Download PDF

Clinical Trial Results:
A Phase 2 Study of Once-Daily LY3502970 Compared with Placebo and Once-Weekly Dulaglutide in Participants with Type 2 Diabetes Mellitus

Summary
EudraCT number	2021-002806-29
Trial protocol	HU SK PL
Global end of trial date	30 Sep 2022

Results information
Results version number	v1(current)
This version publication date	15 Oct 2023
First version publication date	15 Oct 2023
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

J2A-MC-GZGE

ISRCTN number

US NCT number

NCT05048719

WHO universal trial number (UTN)

Other trial identifiers

Trial Number: 17787

Sponsor organisation name

Eli Lilly and Company

Sponsor organisation address

Lilly Corporate Center, Indianapolis, IN, United States, 46285

Public contact

Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,

Scientific contact

Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

30 Sep 2022

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

30 Sep 2022

Was the trial ended prematurely?

Main objective of the trial

The main purpose of this study is to evaluate the efficacy and safety of LY3502970 in participants with type 2 diabetes (T2D) who failed to achieve adequate glycemic control on diet and exercise alone or on a stable dose of metformin. This study will last about 30 weeks.

Protection of trial subjects

This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.

Background therapy

Evidence for comparator

Actual start date of recruitment

15 Sep 2021

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Hungary: 63

Country: Number of subjects enrolled

Poland: 85

Country: Number of subjects enrolled

Slovakia: 65

Country: Number of subjects enrolled

United States: 170

Worldwide total number of subjects

383

EEA total number of subjects

213

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

251

From 65 to 84 years

132

85 years and over

Subject disposition

Top of page

Recruitment details

No Text Available

Screening details

For maintenance doses of LY3502970: 3, 12, 24, 36, and 45 milligrams (mg), the initial dose will be 2 or 3 mg followed by additional escalation steps as appropriate. The dose escalation varied by dose group where the target maintenance dose was achieved between Weeks 4 and 12.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Placebo

Arm description

Participants received matching placebo administered orally or subcutaneously.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Administered orally

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Administered subcutaneously

3 mg LY3502970

Arm description

Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally once daily (QD).

Arm type

Experimental

Investigational medicinal product name

LY3502970

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Administered orally

12 mg LY3502970

Arm description

Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.

Arm type

Experimental

Investigational medicinal product name

LY3502970

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Administered orally

24 mg LY3502970

Arm description

Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD.

Arm type

Experimental

Investigational medicinal product name

LY3502970

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Administered orally

36 mg LY3502970 - 1

Arm description

Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.

Arm type

Experimental

Investigational medicinal product name

LY3502970

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Administered orally

36 mg LY3502970 - 2

Arm description

Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.

Arm type

Experimental

Investigational medicinal product name

LY3502970

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Administered orally

45 mg LY3502970 - 1

Arm description

Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.

Arm type

Experimental

Investigational medicinal product name

LY3502970

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Administered orally

45 mg LY3502970 - 2

Arm description

Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.

Arm type

Active comparator

Investigational medicinal product name

LY3502970

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Administered orally

1.5 mg Dulaglutide

Arm description

Participants received 1.5 mg Dulaglutide administered subcutaneously (SC) once weekly (QW).

Arm type

Placebo

Investigational medicinal product name

Dulaglutide

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Administered subcutaneously

Number of subjects in period 1	Placebo	3 mg LY3502970	12 mg LY3502970	24 mg LY3502970	36 mg LY3502970 - 1	36 mg LY3502970 - 2	45 mg LY3502970 - 1	45 mg LY3502970 - 2	1.5 mg Dulaglutide
Started	55	51	56	47	27	34	31	32	50
Received At Least One Dose of Study Drug	55	51	56	47	27	34	31	32	50
Completed	51	47	50	42	25	30	29	29	49
Not completed	4	4	6	5	2	4	2	3	1
Adverse event, serious fatal	1	-	-	-	-	-	-	-	-
Sponsor decision due To inadvertent Enrollment	-	1	-	-	-	-	-	-	-
Consent withdrawn by subject	2	1	3	1	-	2	1	1	-
Physician decision	-	-	-	-	-	-	-	1	1
Participant decided to Discontinue Treatment	-	-	-	1	-	-	-	-	-
Adverse event, non-fatal	-	1	2	-	1	-	-	-	-
Participant was Unresponsive	-	1	-	-	-	-	-	-	-
Patient Decision due To Changes in Personal Life	1	-	-	-	-	-	-	-	-
Lost to follow-up	-	-	1	3	1	1	1	1	-
Site Terminated Participant due to Sponsor	-	-	-	-	-	1	-	-	-

Baseline characteristics

Top of page

Reporting group title

Placebo

Reporting group description

Participants received matching placebo administered orally or subcutaneously.

Reporting group title

3 mg LY3502970

Reporting group description

Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally once daily (QD).

Reporting group title

12 mg LY3502970

Reporting group description

Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.

Reporting group title

24 mg LY3502970

Reporting group description

Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD.

Reporting group title

36 mg LY3502970 - 1

Reporting group description

Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.

Reporting group title

36 mg LY3502970 - 2

Reporting group description

Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.

Reporting group title

45 mg LY3502970 - 1

Reporting group description

Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.

Reporting group title

45 mg LY3502970 - 2

Reporting group description

Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.

Reporting group title

1.5 mg Dulaglutide

Reporting group description

Participants received 1.5 mg Dulaglutide administered subcutaneously (SC) once weekly (QW).

Reporting group values	Placebo	3 mg LY3502970	12 mg LY3502970	24 mg LY3502970	36 mg LY3502970 - 1	36 mg LY3502970 - 2	45 mg LY3502970 - 1	45 mg LY3502970 - 2	1.5 mg Dulaglutide	Total
Number of subjects	55	51	56	47	27	34	31	32	50	383
Age categorical
Units: Subjects
In utero										0
Preterm newborn infants (gestational age < 37 wks)										0
Newborns (0-27 days)										0
Infants and toddlers (28 days-23 months)										0
Children (2-11 years)										0
Adolescents (12-17 years)										0
Adults (18-64 years)										0
From 65-84 years										0
85 years and over										0
Age continuous
Units: years
arithmetic mean (standard deviation)	58.30 ( 9.52 )	59.00 ( 9.43 )	57.40 ( 9.23 )	60.50 ( 9.11 )	59.20 ( 9.07 )	60.10 ( 9.37 )	58.10 ( 10.63 )	58.90 ( 8.18 )	58.80 ( 10.19 )	-
Gender categorical
Units: Subjects
Female	27	25	20	17	9	16	10	13	20	157
Male	28	26	36	30	18	18	21	19	30	226
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	14	7	15	5	6	7	7	6	7	74
Not Hispanic or Latino	41	44	41	42	21	27	24	26	43	309
Unknown or Not Reported	0	0	0	0	0	0	0	0	0	0
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	1	0	1	1	0	0	0	1	0	4
Asian	0	1	1	1	1	0	0	0	1	5
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0	0	0
Black or African American	4	2	5	2	0	0	2	3	4	22
White	50	47	49	43	25	33	29	28	44	348
More than one race	0	1	0	0	1	1	0	0	1	4
Unknown or Not Reported	0	0	0	0	0	0	0	0	0	0
Region of Enrollment
Units: Subjects
Hungary	10	8	9	8	3	6	6	4	9	63
Poland	11	13	11	10	6	9	7	6	12	85
Slovakia	10	8	10	9	5	5	5	6	7	65
United States	24	22	26	20	13	14	13	16	22	170

End points

Top of page

Reporting group title

Placebo

Reporting group description

Participants received matching placebo administered orally or subcutaneously.

Reporting group title

3 mg LY3502970

Reporting group description

Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally once daily (QD).

Reporting group title

12 mg LY3502970

Reporting group description

Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.

Reporting group title

24 mg LY3502970

Reporting group description

Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD.

Reporting group title

36 mg LY3502970 - 1

Reporting group description

Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.

Reporting group title

36 mg LY3502970 - 2

Reporting group description

Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.

Reporting group title

45 mg LY3502970 - 1

Reporting group description

Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.

Reporting group title

45 mg LY3502970 - 2

Reporting group description

Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.

Reporting group title

1.5 mg Dulaglutide

Reporting group description

Participants received 1.5 mg Dulaglutide administered subcutaneously (SC) once weekly (QW).

Subject analysis set title

36 mg LY3502970

Subject analysis set type

Per protocol

Subject analysis set description

Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally QD.

Subject analysis set title

45 mg LY3502970

Subject analysis set type

Per protocol

Subject analysis set description

Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally QD.

Primary: Change from Baseline in HbA1c in LY3502970 as Compared to Placebo

Top of page

End point title

Change from Baseline in HbA1c in LY3502970 as Compared to Placebo ^[1]

End point description

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Country + Baseline HbA1c Group (<=8.0%, >8.0%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Analysis Population Description (APD): All participants who received at least one dose of LY3502970 or placebo and had baseline and at least one post-baseline value for HbA1c. The statistical analyses were conducted to compare LY3502970 against placebo i.e., comparison groups = LY3502970 vs Placebo. Comparison groups in the individual statistical analyses below may be disregarded.

End point type

Primary

End point timeframe

Baseline, Week 26

Notes
[1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Descriptive statistics was added in baseline period reporting arms, subject analysis set with evaluable endpoint data.

End point values	Placebo	3 mg LY3502970	12 mg LY3502970	24 mg LY3502970	36 mg LY3502970	45 mg LY3502970
Number of subjects analysed	55	46	49	42	57	58
Units: Percentage of HbA1c
least squares mean (standard error)	-0.43 ( 0.128 )	-1.19 ( 0.137 )	-1.91 ( 0.133 )	-1.79 ( 0.149 )	-2.03 ( 0.127 )	-2.10 ( 0.124 )

Outcome measure No.1

Comparison groups

Placebo v 3 mg LY3502970

Number of subjects included in analysis

101

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Least square mean difference

Point estimate

-0.77

Confidence interval

level

95%

sides

2-sided

lower limit

-1.13

upper limit

-0.4

Outcome measure No.1

Comparison groups

Placebo v 12 mg LY3502970

Number of subjects included in analysis

104

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Least square mean difference

Point estimate

-1.49

Confidence interval

level

95%

sides

2-sided

lower limit

-1.85

upper limit

-1.12

Outcome measure No.1

Comparison groups

Placebo v 24 mg LY3502970

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Least square mean difference

Point estimate

-1.36

Confidence interval

level

95%

sides

2-sided

lower limit

-1.75

upper limit

-0.98

Outcome measure No.1

Comparison groups

Placebo v 36 mg LY3502970

Number of subjects included in analysis

112

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Least square mean difference

Point estimate

-1.6

Confidence interval

level

95%

sides

2-sided

lower limit

-1.96

upper limit

-1.25

Outcome measure No.1

Comparison groups

Placebo v 45 mg LY3502970

Number of subjects included in analysis

113

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Least square mean difference

Point estimate

-1.67

Confidence interval

level

95%

sides

2-sided

lower limit

-2.02

upper limit

-1.32

Secondary: Change from Baseline in HbA1c in LY3502970 as Compared to Dulaglutide

Top of page

End point title

Change from Baseline in HbA1c in LY3502970 as Compared to Dulaglutide ^[2]

End point description

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Country + Baseline HbA1c Group (<=8.0%, >8.0%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. APD: All participants who received at least one dose of LY3502970 or dulaglutide, had a baseline, and at least one post-baseline value for HbA1c. The statistical analyses were conducted to compare LY3502970 against Dulaglutide i.e., comparison groups= LY3502970 vs Dulaglutide. Comparison groups in the individual statistical analyses below may be disregarded.

End point type

Secondary

End point timeframe

Baseline, Week 26

Notes
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Descriptive statistics was added in baseline period reporting arms, subject analysis set with evaluable endpoint data.

End point values	3 mg LY3502970	12 mg LY3502970	24 mg LY3502970	1.5 mg Dulaglutide	36 mg LY3502970	45 mg LY3502970
Number of subjects analysed	46	49	42	49	57	58
Units: Percentage of HbA1c
least squares mean (standard error)	-1.19 ( 0.137 )	-1.91 ( 0.133 )	-1.79 ( 0.149 )	-1.10 ( 0.131 )	-2.03 ( 0.127 )	-2.10 ( 0.124 )

Outcome measure No.2

Comparison groups

3 mg LY3502970 v 1.5 mg Dulaglutide

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.626

Method

Mixed models analysis

Parameter type

Least square mean difference

Point estimate

-0.09

Confidence interval

level

95%

sides

2-sided

lower limit

-0.47

upper limit

0.28

Outcome measure No.2

Comparison groups

12 mg LY3502970 v 1.5 mg Dulaglutide

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Least square mean difference

Point estimate

-0.81

Confidence interval

level

95%

sides

2-sided

lower limit

-1.18

upper limit

-0.44

Outcome measure No.2

Comparison groups

24 mg LY3502970 v 1.5 mg Dulaglutide

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Least square mean difference

Point estimate

-0.69

Confidence interval

level

95%

sides

2-sided

lower limit

-1.08

upper limit

-0.3

Outcome measure No.2

Comparison groups

1.5 mg Dulaglutide v 36 mg LY3502970

Number of subjects included in analysis

106

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Least square mean difference

Point estimate

-0.93

Confidence interval

level

95%

sides

2-sided

lower limit

-1.29

upper limit

-0.57

Outcome measure No.2

Comparison groups

1.5 mg Dulaglutide v 45 mg LY3502970

Number of subjects included in analysis

107

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Least square mean difference

Point estimate

-1

Confidence interval

level

95%

sides

2-sided

lower limit

-1.36

upper limit

-0.64

Secondary: Percentage of Participants with HbA1c <7.0%

Top of page

End point title

Percentage of Participants with HbA1c <7.0% ^[3]

End point description

Percentage of Participants with HbA1c <7.0%. Odds ratio was calculated using logistic regression model. APD: All participants who received at least one dose of study drug, had a baseline and at least one post-baseline HbA1c value. The statistical analyses were conducted to compare LY3502970 against placebo i.e., comparison groups = LY3502970 vs Placebo, and LY3502970 against Dulaglutide i.e., comparison groups= LY3502970 vs Dulaglutide. Comparison groups in the individual statistical analyses below may be disregarded.

End point type

Secondary

End point timeframe

Week 26

Notes
[3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Descriptive statistics was added in baseline period reporting arms, subject analysis set with evaluable endpoint data.

End point values	Placebo	3 mg LY3502970	12 mg LY3502970	24 mg LY3502970	1.5 mg Dulaglutide	36 mg LY3502970	45 mg LY3502970
Number of subjects analysed	55	46	49	42	49	57	58
Units: Percentage of participants
number (not applicable)	24.27	65.17	78.92	91.24	64.06	92.75	95.76

Outcome measure No.3

Comparison groups

3 mg LY3502970 v Placebo

Number of subjects included in analysis

101

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

8.19

Confidence interval

level

95%

sides

2-sided

lower limit

2.93

upper limit

22.9

Outcome measure No.3

Comparison groups

Placebo v 12 mg LY3502970

Number of subjects included in analysis

104

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

25.02

Confidence interval

level

95%

sides

2-sided

lower limit

7.57

upper limit

82.69

Outcome measure No.3

Comparison groups

24 mg LY3502970 v Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

62.31

Confidence interval

level

95%

sides

2-sided

lower limit

12.26

upper limit

316.63

Outcome measure No.3

Comparison groups

Placebo v 36 mg LY3502970

Number of subjects included in analysis

112

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

67.57

Confidence interval

level

95%

sides

2-sided

lower limit

17.56

upper limit

259.97

Outcome measure No.3

Comparison groups

Placebo v 45 mg LY3502970

Number of subjects included in analysis

113

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

129.55

Confidence interval

level

95%

sides

2-sided

lower limit

26.72

upper limit

628.09

Outcome measure No.3

Comparison groups

3 mg LY3502970 v 1.5 mg Dulaglutide

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.802

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.13

Confidence interval

level

95%

sides

2-sided

lower limit

0.43

upper limit

2.96

Outcome measure No.3

Comparison groups

12 mg LY3502970 v 1.5 mg Dulaglutide

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.026

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

3.46

Confidence interval

level

95%

sides

2-sided

lower limit

1.16

upper limit

10.31

Outcome measure No.3

Comparison groups

24 mg LY3502970 v 1.5 mg Dulaglutide

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.006

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

8.61

Confidence interval

level

95%

sides

2-sided

lower limit

1.83

upper limit

40.51

Outcome measure No.3

Comparison groups

1.5 mg Dulaglutide v 36 mg LY3502970

Number of subjects included in analysis

106

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

9.34

Confidence interval

level

95%

sides

2-sided

lower limit

2.67

upper limit

32.71

Outcome measure No.3

Comparison groups

1.5 mg Dulaglutide v 45 mg LY3502970

Number of subjects included in analysis

107

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

17.9

Confidence interval

level

95%

sides

2-sided

lower limit

4.02

upper limit

79.7

Secondary: Percentage of Participants with HbA1c ≤ 6.5%

Top of page

End point title

Percentage of Participants with HbA1c ≤ 6.5% ^[4]

End point description

Percentage of Participants with HbA1c ≤ 6.5%. Odds ratio was calculated using logistic regression model. APD: All participants who received at least one dose of study drug, had a baseline and at least one post-baseline HbA1c value. The statistical analyses were conducted to compare LY3502970 against placebo i.e., comparison groups = LY3502970 vs Placebo, and LY3502970 against Dulaglutide i.e., comparison groups= LY3502970 vs Dulaglutide. Comparison groups in the individual statistical analyses below may be disregarded.

End point type

Secondary

End point timeframe

Week 26

Notes
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Descriptive statistics was added in baseline period reporting arms, subject analysis set with evaluable endpoint data.

End point values	Placebo	3 mg LY3502970	12 mg LY3502970	24 mg LY3502970	1.5 mg Dulaglutide	36 mg LY3502970	45 mg LY3502970
Number of subjects analysed	55	46	49	42	49	57	58
Units: Percentage of participants
number (not applicable)	14.56	45.30	70.73	80.12	41.04	79.39	83.52

Outcome measure No.4

Comparison groups

3 mg LY3502970 v Placebo

Number of subjects included in analysis

101

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

6.77

Confidence interval

level

95%

sides

2-sided

lower limit

2.21

upper limit

20.75

Outcome measure No.4

Comparison groups

12 mg LY3502970 v Placebo

Number of subjects included in analysis

104

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

34.09

Confidence interval

level

95%

sides

2-sided

lower limit

9.92

upper limit

117.16

Outcome measure No.4

Comparison groups

24 mg LY3502970 v Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

48.33

Confidence interval

level

95%

sides

2-sided

lower limit

11.9

upper limit

196.24

Outcome measure No.4

Comparison groups

Placebo v 36 mg LY3502970

Number of subjects included in analysis

112

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

45.72

Confidence interval

level

95%

sides

2-sided

lower limit

13.61

upper limit

153.64

Outcome measure No.4

Comparison groups

Placebo v 45 mg LY3502970

Number of subjects included in analysis

113

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

77.23

Confidence interval

level

95%

sides

2-sided

lower limit

20.26

upper limit

294.48

Outcome measure No.4

Comparison groups

3 mg LY3502970 v 1.5 mg Dulaglutide

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.678

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.22

Confidence interval

level

95%

sides

2-sided

lower limit

0.48

upper limit

3.13

Outcome measure No.4

Comparison groups

12 mg LY3502970 v 1.5 mg Dulaglutide

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

6.15

Confidence interval

level

95%

sides

2-sided

lower limit

2.19

upper limit

17.24

Outcome measure No.4

Comparison groups

24 mg LY3502970 v 1.5 mg Dulaglutide

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

8.71

Confidence interval

level

95%

sides

2-sided

lower limit

2.55

upper limit

29.79

Outcome measure No.4

Comparison groups

1.5 mg Dulaglutide v 36 mg LY3502970

Number of subjects included in analysis

106

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

8.24

Confidence interval

level

95%

sides

2-sided

lower limit

3.05

upper limit

22.3

Outcome measure No.4

Comparison groups

1.5 mg Dulaglutide v 45 mg LY3502970

Number of subjects included in analysis

107

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

13.93

Confidence interval

level

95%

sides

2-sided

lower limit

4.51

upper limit

43.01

Secondary: Change From Baseline in Fasting Serum Glucose

Top of page

End point title

Change From Baseline in Fasting Serum Glucose ^[5]

End point description

Fasting glucose is a test to determine sugar levels in blood sample after an overnight fast. LS mean was determined by MMRM model with Baseline + Country + Baseline HbA1c Group (<=8.0%, 8.0%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. APD: All participants who received at least one dose of study drug, had baseline and at least one post-baseline fasting glucose data. The statistical analyses were conducted to compare LY3502970 against placebo i.e., comparison groups = LY3502970 vs Placebo, and LY3502970 against Dulaglutide i.e., comparison groups= LY3502970 vs Dulaglutide. Comparison groups in the individual statistical analyses below may be disregarded.

End point type

Secondary

End point timeframe

Baseline, Week 26

Notes
[5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Descriptive statistics was added in baseline period reporting arms, subject analysis set with evaluable endpoint data.

End point values	Placebo	3 mg LY3502970	12 mg LY3502970	24 mg LY3502970	1.5 mg Dulaglutide	36 mg LY3502970	45 mg LY3502970
Number of subjects analysed	55	46	49	42	49	57	58
Units: milligrams per deciliter (mg/dL)
least squares mean (standard error)	-11.1 ( 3.90 )	-32.6 ( 4.14 )	-53.7 ( 3.92 )	-52.2 ( 4.49 )	-33.2 ( 3.91 )	-53.9 ( 3.79 )	-55.9 ( 3.69 )

Outcome measure No.5

Comparison groups

Placebo v 3 mg LY3502970

Number of subjects included in analysis

101

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Least square mean difference

Point estimate

-21.5

Confidence interval

level

95%

sides

2-sided

lower limit

-32.7

upper limit

-10.3

Outcome measure No.5

Comparison groups

Placebo v 12 mg LY3502970

Number of subjects included in analysis

104

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Least square mean difference

Point estimate

-42.5

Confidence interval

level

95%

sides

2-sided

lower limit

-53.4

upper limit

-31.7

Outcome measure No.5

Comparison groups

Placebo v 24 mg LY3502970

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Least square mean difference

Point estimate

-41

Confidence interval

level

95%

sides

2-sided

lower limit

-52.7

upper limit

-29.3

Outcome measure No.5

Comparison groups

Placebo v 36 mg LY3502970

Number of subjects included in analysis

112

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Least square mean difference

Point estimate

-42.7

Confidence interval

level

95%

sides

2-sided

lower limit

-53.5

upper limit

-32

Outcome measure No.5

Comparison groups

Placebo v 45 mg LY3502970

Number of subjects included in analysis

113

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Least square mean difference

Point estimate

-44.7

Confidence interval

level

95%

sides

2-sided

lower limit

-55.3

upper limit

-34.2

Outcome measure No.5

Comparison groups

3 mg LY3502970 v 1.5 mg Dulaglutide

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Least square mean difference

Point estimate

0.6

Confidence interval

level

95%

sides

2-sided

lower limit

-10.6

upper limit

11.8

Outcome measure No.5

Comparison groups

12 mg LY3502970 v 1.5 mg Dulaglutide

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Least square mean difference

Point estimate

-20.5

Confidence interval

level

95%

sides

2-sided

lower limit

-31.4

upper limit

-9.5

Outcome measure No.5

Comparison groups

24 mg LY3502970 v 1.5 mg Dulaglutide

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.002

Method

Mixed models analysis

Parameter type

Least square mean difference

Point estimate

-19

Confidence interval

level

95%

sides

2-sided

lower limit

-30.7

upper limit

-7.2

Outcome measure No.5

Comparison groups

1.5 mg Dulaglutide v 36 mg LY3502970

Number of subjects included in analysis

106

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Least square mean difference

Point estimate

-20.7

Confidence interval

level

95%

sides

2-sided

lower limit

-31.4

upper limit

-9.9

Outcome measure No.5

Comparison groups

1.5 mg Dulaglutide v 45 mg LY3502970

Number of subjects included in analysis

107

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Least square mean difference

Point estimate

-22.7

Confidence interval

level

95%

sides

2-sided

lower limit

-33.2

upper limit

-12.1

Secondary: Change from Baseline in Body Weight

Top of page

End point title

Change from Baseline in Body Weight ^[6]

End point description

LS mean was determined by MMRM model with Baseline + Country + Baseline HbA1c Group (<=8.0%, >8.0%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. APD: All participants who received at least one dose of study drug, had baseline and at least one post-baseline body weight data. The statistical analyses were conducted to compare LY3502970 against placebo i.e., comparison groups = LY3502970 vs Placebo, and LY3502970 against Dulaglutide i.e., comparison groups= LY3502970 vs Dulaglutide. Comparison groups in the individual statistical analyses below may be disregarded.

End point type

Secondary

End point timeframe

Baseline, Week 26

Notes
[6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Descriptive statistics was added in baseline period reporting arms, subject analysis set with evaluable endpoint data.

End point values	Placebo	3 mg LY3502970	12 mg LY3502970	24 mg LY3502970	1.5 mg Dulaglutide	36 mg LY3502970	45 mg LY3502970
Number of subjects analysed	55	50	53	46	50	57	62
Units: kilograms (kg)
least squares mean (standard error)	-2.2 ( 0.74 )	-3.7 ( 0.79 )	-6.5 ( 0.76 )	-9.7 ( 0.85 )	-3.9 ( 0.76 )	-9.5 ( 0.73 )	-10.1 ( 0.71 )

Outcome measure No.6

Comparison groups

Placebo v 3 mg LY3502970

Number of subjects included in analysis

105

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.153

Method

Mixed models analysis

Parameter type

Least square mean difference

Point estimate

-1.6

Confidence interval

level

95%

sides

2-sided

lower limit

-3.7

upper limit

0.6

Outcome measure No.6

Comparison groups

Placebo v 12 mg LY3502970

Number of subjects included in analysis

108

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Least square mean difference

Point estimate

-4.3

Confidence interval

level

95%

sides

2-sided

lower limit

-6.4

upper limit

-2.2

Outcome measure No.6

Comparison groups

Placebo v 24 mg LY3502970

Number of subjects included in analysis

101

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Least square mean difference

Point estimate

-7.6

Confidence interval

level

95%

sides

2-sided

lower limit

-9.8

upper limit

-5.3

Outcome measure No.6

Comparison groups

Placebo v 36 mg LY3502970

Number of subjects included in analysis

112

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Least square mean difference

Point estimate

-7.4

Confidence interval

level

95%

sides

2-sided

lower limit

-9.4

upper limit

-5.3

Outcome measure No.6

Comparison groups

Placebo v 45 mg LY3502970

Number of subjects included in analysis

117

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Least square mean difference

Point estimate

-7.9

Confidence interval

level

95%

sides

2-sided

lower limit

-9.9

upper limit

-5.9

Outcome measure No.6

Comparison groups

3 mg LY3502970 v 1.5 mg Dulaglutide

Number of subjects included in analysis

100

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.914

Method

Mixed models analysis

Parameter type

Least square mean difference

Point estimate

0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-2

upper limit

2.3

Outcome measure No.6

Comparison groups

12 mg LY3502970 v 1.5 mg Dulaglutide

Number of subjects included in analysis

103

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.015

Method

Mixed models analysis

Parameter type

Least square mean difference

Point estimate

-2.6

Confidence interval

level

95%

sides

2-sided

lower limit

-4.7

upper limit

-0.5

Outcome measure No.6

Comparison groups

24 mg LY3502970 v 1.5 mg Dulaglutide

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Least square mean difference

Point estimate

-5.9

Confidence interval

level

95%

sides

2-sided

lower limit

-8.1

upper limit

-3.6

Outcome measure No.6

Comparison groups

1.5 mg Dulaglutide v 36 mg LY3502970

Number of subjects included in analysis

107

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Least square mean difference

Point estimate

-5.7

Confidence interval

level

95%

sides

2-sided

lower limit

-7.8

upper limit

-3.6

Outcome measure No.6

Comparison groups

1.5 mg Dulaglutide v 45 mg LY3502970

Number of subjects included in analysis

112

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Least square mean difference

Point estimate

-6.2

Confidence interval

level

95%

sides

2-sided

lower limit

-8.3

upper limit

-4.2

Secondary: Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970

Top of page

End point title

Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970 ^[7]

End point description

PK: Steady State AUC of LY3502970. APD: All participants who received at least one dose of LY3502970 and had evaluable PK data.

End point type

Secondary

End point timeframe

Pre-dose (Week (wk) 0, wk 8, wk 12, and wk 26); Post-dose (wk 4, wk 8, wk 16, wk 20, and end of treatment).

Notes
[7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Descriptive statistics was added in baseline period reporting arms, subject analysis set with evaluable endpoint data.

End point values	3 mg LY3502970	12 mg LY3502970	24 mg LY3502970	36 mg LY3502970 - 1	36 mg LY3502970 - 2	45 mg LY3502970 - 1	45 mg LY3502970 - 2
Number of subjects analysed	45	48	43	24	29	25	28
Units: nanogram hour per milliliter (ng*h/mL)
geometric mean (geometric coefficient of variation)	364 ( 38.7 )	1020 ( 63.5 )	1500 ( 84.5 )	1830 ( 94.6 )	2430 ( 39.8 )	2230 ( 80.4 )	2550 ( 55.3 )

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

Entire Study

Adverse event reporting additional description

J2A-MC-GZGE

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

25.0

Reporting group title

Placebo

Reporting group description

Participants received matching placebo.

Reporting group title

3 mg LY3502970

Reporting group description

Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally QD.

Reporting group title

12 mg LY3502970

Reporting group description

Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.

Reporting group title

24 mg LY3502970

Reporting group description

Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD.

Reporting group title

36 mg LY3502970 - 1

Reporting group description

Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.

Reporting group title

36 mg LY3502970 - 2

Reporting group description

Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.

Reporting group title

45 mg LY3502970 - 1

Reporting group description

Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.

Reporting group title

45 mg LY3502970 - 2

Reporting group description

Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.

Reporting group title

1.5 mg Dulaglutide

Reporting group description

Participants received 1.5 mg Dulaglutide administered SC QW.

Serious adverse events	Placebo	3 mg LY3502970	12 mg LY3502970	24 mg LY3502970	36 mg LY3502970 - 1	36 mg LY3502970 - 2	45 mg LY3502970 - 1	45 mg LY3502970 - 2	1.5 mg Dulaglutide
Total subjects affected by serious adverse events
subjects affected / exposed	3 / 55 (5.45%)	3 / 51 (5.88%)	1 / 56 (1.79%)	5 / 47 (10.64%)	1 / 27 (3.70%)	1 / 34 (2.94%)	0 / 31 (0.00%)	1 / 32 (3.13%)	1 / 50 (2.00%)
number of deaths (all causes)	1	0	0	0	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0	0	0	0	0
Injury, poisoning and procedural complications
facial bones fracture
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	1 / 55 (1.82%)	0 / 51 (0.00%)	0 / 56 (0.00%)	0 / 47 (0.00%)	0 / 27 (0.00%)	0 / 34 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
fractured coccyx
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 55 (0.00%)	0 / 51 (0.00%)	0 / 56 (0.00%)	0 / 47 (0.00%)	0 / 27 (0.00%)	0 / 34 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	1 / 50 (2.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
lumbar vertebral fracture
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 55 (0.00%)	0 / 51 (0.00%)	0 / 56 (0.00%)	0 / 47 (0.00%)	0 / 27 (0.00%)	0 / 34 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	1 / 50 (2.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
radius fracture
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	1 / 55 (1.82%)	0 / 51 (0.00%)	0 / 56 (0.00%)	0 / 47 (0.00%)	0 / 27 (0.00%)	0 / 34 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
atrial fibrillation
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 55 (0.00%)	1 / 51 (1.96%)	0 / 56 (0.00%)	0 / 47 (0.00%)	0 / 27 (0.00%)	0 / 34 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
cardiac failure
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	1 / 55 (1.82%)	0 / 51 (0.00%)	0 / 56 (0.00%)	0 / 47 (0.00%)	0 / 27 (0.00%)	0 / 34 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
ischaemic stroke
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	1 / 55 (1.82%)	0 / 51 (0.00%)	0 / 56 (0.00%)	0 / 47 (0.00%)	1 / 27 (3.70%)	0 / 34 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Immune system disorders
haemophagocytic lymphohistiocytosis
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 55 (0.00%)	1 / 51 (1.96%)	0 / 56 (0.00%)	0 / 47 (0.00%)	0 / 27 (0.00%)	0 / 34 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
gastrointestinal haemorrhage
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 55 (0.00%)	0 / 51 (0.00%)	0 / 56 (0.00%)	1 / 47 (2.13%)	0 / 27 (0.00%)	0 / 34 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
pancreatitis acute
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 55 (0.00%)	0 / 51 (0.00%)	0 / 56 (0.00%)	1 / 47 (2.13%)	0 / 27 (0.00%)	0 / 34 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
pylorospasm
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 55 (0.00%)	0 / 51 (0.00%)	0 / 56 (0.00%)	1 / 47 (2.13%)	0 / 27 (0.00%)	0 / 34 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
varices oesophageal
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 55 (0.00%)	0 / 51 (0.00%)	0 / 56 (0.00%)	1 / 47 (2.13%)	0 / 27 (0.00%)	0 / 34 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
urethral haemorrhage
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 55 (0.00%)	0 / 51 (0.00%)	0 / 56 (0.00%)	0 / 47 (0.00%)	0 / 27 (0.00%)	1 / 34 (2.94%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
osteoarthritis
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	1 / 55 (1.82%)	0 / 51 (0.00%)	0 / 56 (0.00%)	0 / 47 (0.00%)	0 / 27 (0.00%)	0 / 34 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
appendicitis
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 55 (0.00%)	0 / 51 (0.00%)	0 / 56 (0.00%)	1 / 47 (2.13%)	0 / 27 (0.00%)	0 / 34 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
covid-19
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 55 (0.00%)	0 / 51 (0.00%)	1 / 56 (1.79%)	0 / 47 (0.00%)	0 / 27 (0.00%)	0 / 34 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
pneumonia
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 55 (0.00%)	1 / 51 (1.96%)	0 / 56 (0.00%)	0 / 47 (0.00%)	0 / 27 (0.00%)	0 / 34 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
dehydration
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 55 (0.00%)	0 / 51 (0.00%)	0 / 56 (0.00%)	1 / 47 (2.13%)	0 / 27 (0.00%)	0 / 34 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
diabetic ketoacidosis
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 55 (0.00%)	0 / 51 (0.00%)	0 / 56 (0.00%)	0 / 47 (0.00%)	0 / 27 (0.00%)	0 / 34 (0.00%)	0 / 31 (0.00%)	1 / 32 (3.13%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
hypoglycaemia
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 55 (0.00%)	0 / 51 (0.00%)	0 / 56 (0.00%)	0 / 47 (0.00%)	0 / 27 (0.00%)	1 / 34 (2.94%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 50 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Placebo	3 mg LY3502970	12 mg LY3502970	24 mg LY3502970	36 mg LY3502970 - 1	36 mg LY3502970 - 2	45 mg LY3502970 - 1	45 mg LY3502970 - 2	1.5 mg Dulaglutide
Total subjects affected by non serious adverse events
subjects affected / exposed	25 / 55 (45.45%)	34 / 51 (66.67%)	40 / 56 (71.43%)	32 / 47 (68.09%)	21 / 27 (77.78%)	18 / 34 (52.94%)	21 / 31 (67.74%)	23 / 32 (71.88%)	23 / 50 (46.00%)
Investigations
haemoglobin decreased
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 55 (0.00%)	0 / 51 (0.00%)	0 / 56 (0.00%)	0 / 47 (0.00%)	2 / 27 (7.41%)	0 / 34 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 50 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0	0
lipase increased
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	2 / 55 (3.64%)	2 / 51 (3.92%)	5 / 56 (8.93%)	4 / 47 (8.51%)	1 / 27 (3.70%)	2 / 34 (5.88%)	2 / 31 (6.45%)	0 / 32 (0.00%)	1 / 50 (2.00%)
occurrences all number	2	2	5	4	1	2	2	0	1
weight decreased
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 55 (0.00%)	0 / 51 (0.00%)	2 / 56 (3.57%)	2 / 47 (4.26%)	3 / 27 (11.11%)	2 / 34 (5.88%)	1 / 31 (3.23%)	0 / 32 (0.00%)	0 / 50 (0.00%)
occurrences all number	0	0	2	2	3	2	1	0	0
Vascular disorders
hypertension
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	4 / 55 (7.27%)	3 / 51 (5.88%)	1 / 56 (1.79%)	0 / 47 (0.00%)	1 / 27 (3.70%)	2 / 34 (5.88%)	0 / 31 (0.00%)	1 / 32 (3.13%)	2 / 50 (4.00%)
occurrences all number	4	3	1	0	1	2	0	1	2
Cardiac disorders
palpitations
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 55 (0.00%)	1 / 51 (1.96%)	3 / 56 (5.36%)	0 / 47 (0.00%)	1 / 27 (3.70%)	0 / 34 (0.00%)	0 / 31 (0.00%)	1 / 32 (3.13%)	1 / 50 (2.00%)
occurrences all number	0	1	3	0	1	0	0	1	1
sinus tachycardia
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 55 (0.00%)	1 / 51 (1.96%)	0 / 56 (0.00%)	2 / 47 (4.26%)	0 / 27 (0.00%)	2 / 34 (5.88%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 50 (0.00%)
occurrences all number	0	1	0	2	0	2	0	0	0
Nervous system disorders
dizziness
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	1 / 55 (1.82%)	4 / 51 (7.84%)	1 / 56 (1.79%)	2 / 47 (4.26%)	0 / 27 (0.00%)	1 / 34 (2.94%)	0 / 31 (0.00%)	1 / 32 (3.13%)	0 / 50 (0.00%)
occurrences all number	1	4	1	2	0	1	0	1	0
headache
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 55 (0.00%)	7 / 51 (13.73%)	2 / 56 (3.57%)	2 / 47 (4.26%)	0 / 27 (0.00%)	1 / 34 (2.94%)	2 / 31 (6.45%)	4 / 32 (12.50%)	0 / 50 (0.00%)
occurrences all number	0	9	2	2	0	1	2	4	0
paraesthesia
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	1 / 55 (1.82%)	0 / 51 (0.00%)	0 / 56 (0.00%)	1 / 47 (2.13%)	0 / 27 (0.00%)	0 / 34 (0.00%)	0 / 31 (0.00%)	2 / 32 (6.25%)	0 / 50 (0.00%)
occurrences all number	1	0	0	2	0	0	0	3	0
General disorders and administration site conditions
asthenia
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 55 (0.00%)	0 / 51 (0.00%)	0 / 56 (0.00%)	0 / 47 (0.00%)	2 / 27 (7.41%)	0 / 34 (0.00%)	1 / 31 (3.23%)	0 / 32 (0.00%)	0 / 50 (0.00%)
occurrences all number	0	0	0	0	2	0	1	0	0
fatigue
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	2 / 55 (3.64%)	3 / 51 (5.88%)	5 / 56 (8.93%)	0 / 47 (0.00%)	1 / 27 (3.70%)	2 / 34 (5.88%)	2 / 31 (6.45%)	1 / 32 (3.13%)	0 / 50 (0.00%)
occurrences all number	2	3	5	0	2	2	2	1	0
Gastrointestinal disorders
abdominal distension
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 55 (0.00%)	2 / 51 (3.92%)	3 / 56 (5.36%)	2 / 47 (4.26%)	2 / 27 (7.41%)	0 / 34 (0.00%)	0 / 31 (0.00%)	1 / 32 (3.13%)	0 / 50 (0.00%)
occurrences all number	0	2	3	2	3	0	0	1	0
abdominal pain upper
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 55 (0.00%)	3 / 51 (5.88%)	1 / 56 (1.79%)	3 / 47 (6.38%)	2 / 27 (7.41%)	0 / 34 (0.00%)	0 / 31 (0.00%)	1 / 32 (3.13%)	0 / 50 (0.00%)
occurrences all number	0	5	2	3	3	0	0	1	0
constipation
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	1 / 55 (1.82%)	7 / 51 (13.73%)	7 / 56 (12.50%)	6 / 47 (12.77%)	6 / 27 (22.22%)	1 / 34 (2.94%)	1 / 31 (3.23%)	4 / 32 (12.50%)	0 / 50 (0.00%)
occurrences all number	1	9	8	7	6	1	1	5	0
diarrhoea
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	4 / 55 (7.27%)	11 / 51 (21.57%)	9 / 56 (16.07%)	7 / 47 (14.89%)	7 / 27 (25.93%)	2 / 34 (5.88%)	9 / 31 (29.03%)	9 / 32 (28.13%)	6 / 50 (12.00%)
occurrences all number	6	18	10	11	8	3	10	11	7
dyspepsia
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	2 / 55 (3.64%)	6 / 51 (11.76%)	4 / 56 (7.14%)	3 / 47 (6.38%)	3 / 27 (11.11%)	2 / 34 (5.88%)	2 / 31 (6.45%)	2 / 32 (6.25%)	1 / 50 (2.00%)
occurrences all number	2	6	4	3	5	2	2	2	1
eructation
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 55 (0.00%)	4 / 51 (7.84%)	2 / 56 (3.57%)	3 / 47 (6.38%)	5 / 27 (18.52%)	3 / 34 (8.82%)	2 / 31 (6.45%)	1 / 32 (3.13%)	1 / 50 (2.00%)
occurrences all number	0	4	3	3	11	3	2	1	1
flatulence
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	1 / 55 (1.82%)	0 / 51 (0.00%)	0 / 56 (0.00%)	4 / 47 (8.51%)	3 / 27 (11.11%)	1 / 34 (2.94%)	1 / 31 (3.23%)	1 / 32 (3.13%)	1 / 50 (2.00%)
occurrences all number	2	0	0	5	5	1	1	1	1
gastrooesophageal reflux disease
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 55 (0.00%)	0 / 51 (0.00%)	4 / 56 (7.14%)	3 / 47 (6.38%)	0 / 27 (0.00%)	2 / 34 (5.88%)	1 / 31 (3.23%)	1 / 32 (3.13%)	1 / 50 (2.00%)
occurrences all number	0	0	4	4	0	3	2	1	1
nausea
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	3 / 55 (5.45%)	12 / 51 (23.53%)	21 / 56 (37.50%)	16 / 47 (34.04%)	10 / 27 (37.04%)	9 / 34 (26.47%)	9 / 31 (29.03%)	8 / 32 (25.00%)	9 / 50 (18.00%)
occurrences all number	4	15	27	20	20	18	15	9	13
retching
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 55 (0.00%)	0 / 51 (0.00%)	0 / 56 (0.00%)	0 / 47 (0.00%)	2 / 27 (7.41%)	0 / 34 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 50 (0.00%)
occurrences all number	0	0	0	0	3	0	0	0	0
vomiting
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	1 / 55 (1.82%)	3 / 51 (5.88%)	12 / 56 (21.43%)	13 / 47 (27.66%)	9 / 27 (33.33%)	7 / 34 (20.59%)	11 / 31 (35.48%)	7 / 32 (21.88%)	4 / 50 (8.00%)
occurrences all number	1	3	16	16	28	9	18	10	4
Reproductive system and breast disorders
epididymal cyst
alternative dictionary used: MedDRA 25.0
subjects affected / exposed ^[1]	0 / 28 (0.00%)	0 / 26 (0.00%)	0 / 36 (0.00%)	0 / 30 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 21 (0.00%)	0 / 19 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0
Skin and subcutaneous tissue disorders
urticaria
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 55 (0.00%)	0 / 51 (0.00%)	2 / 56 (3.57%)	0 / 47 (0.00%)	2 / 27 (7.41%)	0 / 34 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 50 (0.00%)
occurrences all number	0	0	3	0	2	0	0	0	0
Musculoskeletal and connective tissue disorders
arthralgia
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 55 (0.00%)	0 / 51 (0.00%)	2 / 56 (3.57%)	1 / 47 (2.13%)	1 / 27 (3.70%)	1 / 34 (2.94%)	0 / 31 (0.00%)	2 / 32 (6.25%)	0 / 50 (0.00%)
occurrences all number	0	0	2	1	1	1	0	4	0
back pain
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	1 / 55 (1.82%)	1 / 51 (1.96%)	0 / 56 (0.00%)	3 / 47 (6.38%)	0 / 27 (0.00%)	0 / 34 (0.00%)	1 / 31 (3.23%)	1 / 32 (3.13%)	0 / 50 (0.00%)
occurrences all number	1	1	0	3	0	0	1	1	0
muscle spasms
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	1 / 55 (1.82%)	1 / 51 (1.96%)	1 / 56 (1.79%)	0 / 47 (0.00%)	0 / 27 (0.00%)	0 / 34 (0.00%)	0 / 31 (0.00%)	2 / 32 (6.25%)	0 / 50 (0.00%)
occurrences all number	1	1	1	0	0	0	0	2	0
Infections and infestations
bacterial vaginosis
alternative dictionary used: MedDRA 25.0
subjects affected / exposed ^[2]	0 / 27 (0.00%)	0 / 25 (0.00%)	0 / 20 (0.00%)	0 / 17 (0.00%)	0 / 9 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	1 / 20 (5.00%)
occurrences all number	0	0	0	0	0	0	0	0	1
covid-19
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	3 / 55 (5.45%)	2 / 51 (3.92%)	5 / 56 (8.93%)	2 / 47 (4.26%)	0 / 27 (0.00%)	2 / 34 (5.88%)	1 / 31 (3.23%)	2 / 32 (6.25%)	2 / 50 (4.00%)
occurrences all number	3	2	5	2	0	2	1	2	2
upper respiratory tract infection
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	4 / 55 (7.27%)	2 / 51 (3.92%)	1 / 56 (1.79%)	2 / 47 (4.26%)	0 / 27 (0.00%)	2 / 34 (5.88%)	0 / 31 (0.00%)	1 / 32 (3.13%)	2 / 50 (4.00%)
occurrences all number	5	2	1	2	0	2	0	1	3
urinary tract infection
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 55 (0.00%)	3 / 51 (5.88%)	0 / 56 (0.00%)	1 / 47 (2.13%)	0 / 27 (0.00%)	1 / 34 (2.94%)	1 / 31 (3.23%)	1 / 32 (3.13%)	2 / 50 (4.00%)
occurrences all number	0	3	0	1	0	1	1	1	3
Metabolism and nutrition disorders
decreased appetite
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	0 / 55 (0.00%)	3 / 51 (5.88%)	3 / 56 (5.36%)	2 / 47 (4.26%)	2 / 27 (7.41%)	1 / 34 (2.94%)	2 / 31 (6.45%)	3 / 32 (9.38%)	2 / 50 (4.00%)
occurrences all number	0	3	4	2	2	1	2	4	2
hyperglycaemia
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	5 / 55 (9.09%)	1 / 51 (1.96%)	0 / 56 (0.00%)	0 / 47 (0.00%)	0 / 27 (0.00%)	0 / 34 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	1 / 50 (2.00%)
occurrences all number	5	1	0	0	0	0	0	0	1

Notes
[1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
[2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.

More information

Top of page

Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Clinical trials

Clinical Trial Results:
A Phase 2 Study of Once-Daily LY3502970 Compared with Placebo and Once-Weekly Dulaglutide in Participants with Type 2 Diabetes Mellitus

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Change from Baseline in HbA1c in LY3502970 as Compared to Placebo

Primary: Change from Baseline in HbA1c in LY3502970 as Compared to Placebo

Secondary: Change from Baseline in HbA1c in LY3502970 as Compared to Dulaglutide

Secondary: Change from Baseline in HbA1c in LY3502970 as Compared to Dulaglutide

Secondary: Percentage of Participants with HbA1c <7.0%

Secondary: Percentage of Participants with HbA1c <7.0%

Secondary: Percentage of Participants with HbA1c ≤ 6.5%

Secondary: Percentage of Participants with HbA1c ≤ 6.5%

Secondary: Change From Baseline in Fasting Serum Glucose

Secondary: Change From Baseline in Fasting Serum Glucose

Secondary: Change from Baseline in Body Weight

Secondary: Change from Baseline in Body Weight

Secondary: Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970

Secondary: Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: A Phase 2 Study of Once-Daily LY3502970 Compared with Placebo and Once-Weekly Dulaglutide in Participants with Type 2 Diabetes Mellitus

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Change from Baseline in HbA1c in LY3502970 as Compared to Placebo

Primary: Change from Baseline in HbA1c in LY3502970 as Compared to Placebo

Secondary: Change from Baseline in HbA1c in LY3502970 as Compared to Dulaglutide

Secondary: Change from Baseline in HbA1c in LY3502970 as Compared to Dulaglutide

Secondary: Percentage of Participants with HbA1c <7.0%

Secondary: Percentage of Participants with HbA1c <7.0%

Secondary: Percentage of Participants with HbA1c ≤ 6.5%

Secondary: Percentage of Participants with HbA1c ≤ 6.5%

Secondary: Change From Baseline in Fasting Serum Glucose

Secondary: Change From Baseline in Fasting Serum Glucose

Secondary: Change from Baseline in Body Weight

Secondary: Change from Baseline in Body Weight

Secondary: Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970

Secondary: Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase 2 Study of Once-Daily LY3502970 Compared with Placebo and Once-Weekly Dulaglutide in Participants with Type 2 Diabetes Mellitus