Download PDF

Clinical Trial Results:
Effect of liraglutide for weight management in pubertal adolescent subjects with obesity. 56-week, double-blind, randomised, parallel-group, placebo-controlled multi-national trial followed by a 26-week period off study-drug

Summary
EudraCT number	2014-004353-14
Trial protocol	SE BE
Global end of trial date	08 Aug 2019

Results information
Results version number	v1(current)
This version publication date	21 Feb 2020
First version publication date	21 Feb 2020
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

NN8022-4180

ISRCTN number

US NCT number

NCT02918279

WHO universal trial number (UTN)

U1111-1162-7101

Sponsor organisation name

Novo Nordisk A/S

Sponsor organisation address

Novo Allé, Bagsvaerd, Denmark, 2880

Public contact

Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S, clinicaltrials@novonordisk.com

Scientific contact

Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S, clinicaltrials@novonordisk.com

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

Yes

EMA paediatric investigation plan number(s)

EMEA-000128-PIP02-09

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?

Yes

Analysis stage

Final

Date of interim/final analysis

23 Dec 2019

Is this the analysis of the primary completion data?

Yes

Primary completion date

14 Feb 2019

Global end of trial reached?

Yes

Global end of trial date

08 Aug 2019

Was the trial ended prematurely?

Main objective of the trial

To compare the efficacy of liraglutide versus placebo on weight loss in adolescent subjects with obesity after 56 weeks of treatment

Protection of trial subjects

The trial was conducted in accordance with the Declaration of Helsinki (Last amended by the 64th World Medical Association General Assembly, Fortaleza, Brazil. October 2013) and ICH Good Clinical Practice, including archiving of essential documents (E6(R1), Step 4. 10 June 1996) and 21 CFR 312.120.

Background therapy

Not applicable.

Evidence for comparator

Not applicable.

Actual start date of recruitment

29 Sep 2016

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Belgium: 33

Country: Number of subjects enrolled

Mexico: 46

Country: Number of subjects enrolled

Russian Federation: 68

Country: Number of subjects enrolled

Sweden: 44

Country: Number of subjects enrolled

United States: 60

Worldwide total number of subjects

251

EEA total number of subjects

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)

251

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

This trial was conducted at 32 sites in 5 countries: Belgium (6 sites), Sweden (4 sites), Russia (8 sites), Mexico (2 sites) and the United States of America (USA - 12 sites). Additionally, 1 site in the USA was approved by the independent review board, but did not randomise any subject.

Screening details

This trial consisted of a 12-week run-in period, during which participants received counselling on healthy nutrition and physical activity. Completed numbers include participants who completed the trial without prematurely discontinuing the trial product and participants who discontinued the trial product but came for the week 82 follow-up visit.

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

Blinding implementation details

Liraglutide and placebo injections were visually identical.

Are arms mutually exclusive

Yes

Liraglutide 3.0 mg

Arm description

Subjects received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57–82).

Arm type

Experimental

Investigational medicinal product name

Liraglutide

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Liraglutide was administered once daily by subcutaneous (s.c.; under the skin) injection in the abdomen, thigh or upper arm irrespective of the timing of meals.

Placebo

Arm description

Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57–82).

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.

Number of subjects in period 1	Liraglutide 3.0 mg	Placebo
Started	125	126
Full analysis set	125	126
Safety analysis set	125	126
Completed	112	103
Not completed	13	23
Consent withdrawn by subject	5	15
Unspecified	3	1
Lost to follow-up	3	6
Withdrawal by parent/guardian	2	1

Baseline characteristics

Top of page

Reporting group title

Liraglutide 3.0 mg

Reporting group description

Reporting group title

Placebo

Reporting group description

Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57–82).

Reporting group values	Liraglutide 3.0 mg	Placebo	Total
Number of subjects	125	126	251
Age Categorical
Units: Subjects
Adolescents (12-17 years)	125	126	251
Age Continuous
Units: years
arithmetic mean (standard deviation)	14.6 ( 1.6 )	14.5 ( 1.6 )	-
Gender Categorical
Units: Subjects
Female	71	78	149
Male	54	48	102

End points

Top of page

Reporting group title

Liraglutide 3.0 mg

Reporting group description

Reporting group title

Placebo

Reporting group description

Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57–82).

Primary: Change in body mass index (BMI) standard deviation score (SDS)

Top of page

End point title

Change in body mass index (BMI) standard deviation score (SDS)

End point description

Change from baseline (Wk 0) in BMI SDS was evaluated at Wk 56. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents’ BMI provided for each sex and age. For each subject, a SDS Z was calculated based on age and sex referring to the values L, M and S. The method is described in the world health organisation (WHO) Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below −3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation. Results are based on the FAS and included both the participants who completed treatment for 56 weeks and participants who could not complete treatment for 56 weeks, but attended the follow-up visit at week 56.

End point type

Primary

End point timeframe

From baseline (randomisation) to 56 weeks

End point values	Liraglutide 3.0 mg	Placebo
Number of subjects analysed	113	105
Units: SDS score
arithmetic mean (standard deviation)	-0.25 ( 0.51 )	-0.02 ( 0.54 )

Liraglutide 3.0 mg – Placebo

Statistical analysis description

Analysis of in-trial data with missing observations was imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Responses at week 56 were analysed using an analysis of covariance model with treatment, sex, region, baseline glycaemic category, stratification factor for Tanner stage and interaction between baseline glycaemic category and stratification factor for Tanner stage as fixed effects, baseline BMI SDS, age as covariates.

Comparison groups

Placebo v Liraglutide 3.0 mg

Number of subjects included in analysis

218

Analysis specification

Pre-specified

Analysis type

superiority ^[1]

P-value

= 0.0022

Method

ANCOVA

Parameter type

Treatment difference

Point estimate

-0.22

Confidence interval

level

95%

sides

2-sided

lower limit

-0.37

upper limit

-0.08

Notes
[1] - The “number of subjects included in analysis” is being erroneously displayed as 218. Actual “number of subjects included in analysis” is 251.

Secondary: Percent of subjects achieving ≥5% reduction in baseline BMI

Top of page

End point title

Percent of subjects achieving ≥5% reduction in baseline BMI

End point description

Participants achieving more than or equal to 5% reduction in their baseline (week 0) body mass index (BMI) was evaluated at weeks 56. Results are based on the FAS and included both participants who completed the 56-week trial period and participants who could not complete the 56-week trial period, but attended the follow-up visit at week 56. The FAS included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the intention-to-treat [ITT] principle).

End point type

Secondary

End point timeframe

At week 56

End point values	Liraglutide 3.0 mg	Placebo
Number of subjects analysed	113	105
Units: Percentage of participants
number (not applicable)
Yes	45.1	19.0
No	54.9	81.0

No statistical analyses for this end point

Secondary: Percent of subjects achieving ≥10% reduction in baseline BMI

Top of page

End point title

Percent of subjects achieving ≥10% reduction in baseline BMI

End point description

Participants achieving more than or equal to 10% reduction in their baseline (week 0) BMI was evaluated at weeks 56. Results are based on the FAS and included both participants who completed the 56-week trial period and participants who could not complete the 56-week trial period, but attended the follow-up visit at week 56. The FAS included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle).

End point type

Secondary

End point timeframe

At week 56

End point values	Liraglutide 3.0 mg	Placebo
Number of subjects analysed	113	105
Units: Percentage of participants
number (not applicable)
Yes	29.2	8.6
No	70.8	91.4

No statistical analyses for this end point

Secondary: Change in BMI from baseline to 56 weeks

Top of page

End point title

Change in BMI from baseline to 56 weeks

End point description

Change in BMI was evaluated from baseline (week 0) to weeks 56. Results are based on the FAS and included both participants who completed the 56-week trial period and participants who could not complete the 56-week trial period, but attended the follow-up visit at week 56. The FAS included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle).

End point type

Secondary

End point timeframe

From baseline to 56 weeks

End point values	Liraglutide 3.0 mg	Placebo
Number of subjects analysed	113	105
Units: kg/m^2
arithmetic mean (standard deviation)	-1.6 ( 3.1 )	0.1 ( 3.4 )

No statistical analyses for this end point

Secondary: Change in body weight (kilogram [kg]) from baseline to 56 weeks

Top of page

End point title

Change in body weight (kilogram [kg]) from baseline to 56 weeks

End point description

Change in body weight (kg) was evaluated from baseline (week 0) to weeks 56. Results are based on the FAS and included both participants who completed the 56-week trial period and participants who could not complete the 56-week trial period, but attended the follow-up visit at week 56. The FAS included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle).

End point type

Secondary

End point timeframe

From baseline to 56 weeks

End point values	Liraglutide 3.0 mg	Placebo
Number of subjects analysed	113	105
Units: kg
arithmetic mean (standard deviation)	-2.7 ( 9.1 )	2.1 ( 10.2 )

No statistical analyses for this end point

Secondary: Change in body weight (pounds [lb]) from baseline to 56 weeks

Top of page

End point title

Change in body weight (pounds [lb]) from baseline to 56 weeks

End point description

Body weight was not analysed in pounds (lb). It was analysed for standard unit, ‘kg’ only.

End point type

Secondary

End point timeframe

From baseline to 56 weeks

End point values	Liraglutide 3.0 mg	Placebo
Number of subjects analysed	0 ^[2]	0 ^[3]
Units: lb
arithmetic mean (standard deviation)	( )	( )

Notes
[2] - Body weight was not analysed in pounds (lb). It was analysed for standard unit, ‘kg’ only.
[3] - Body weight was not analysed in pounds (lb). It was analysed for standard unit, ‘kg’ only.

No statistical analyses for this end point

Secondary: Change in body weight (percent [%]) from baseline to 56 weeks

Top of page

End point title

Change in body weight (percent [%]) from baseline to 56 weeks

End point description

Relative change in body weight (kg) was evaluated from baseline (week 0) to weeks 56. Results are based on the FAS and included both participants who completed the 56-week trial period and participants who could not complete the 56-week trial period, but attended the follow-up visit at week 56. The FAS included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle).

End point type

Secondary

End point timeframe

From baseline to 56 weeks

End point values	Liraglutide 3.0 mg	Placebo
Number of subjects analysed	113	105
Units: Percentage change
arithmetic mean (standard deviation)	-3.2 ( 9.4 )	2.2 ( 9.5 )

No statistical analyses for this end point

Secondary: Change in systolic and diastolic blood pressure

Top of page

End point title

Change in systolic and diastolic blood pressure

End point description

Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated from baseline (week 0) to weeks 56. Results are based on the FAS and included participants who completed the 56-week trial period. The FAS included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle).

End point type

Secondary

End point timeframe

From baseline to 56 weeks

End point values	Liraglutide 3.0 mg	Placebo
Number of subjects analysed	102	101
Units: mmHg
arithmetic mean (standard deviation)
SBP	-2 ( 10 )	1 ( 10 )
DBP	1 ( 9 )	-1 ( 9 )

No statistical analyses for this end point

Secondary: Change in glycosylated haemoglobin (HbA1c)

Top of page

End point title

Change in glycosylated haemoglobin (HbA1c)

End point description

Change in HbA1c was evaluated from baseline (week 0) to weeks 56. Results are based on the FAS and included participants who completed the 56-week trial period. The FAS included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle).

End point type

Secondary

End point timeframe

From baseline to 56 weeks

End point values	Liraglutide 3.0 mg	Placebo
Number of subjects analysed	105	101
Units: Percentage of HbA1c
arithmetic mean (standard deviation)	-0.1 ( 0.3 )	-0.0 ( 0.2 )

No statistical analyses for this end point

Secondary: Change in fasting plasma glucose

Top of page

End point title

Change in fasting plasma glucose

End point description

Change in fasting plasma glucose (FPG) was evaluated from baseline (week 0) to weeks 56. Results are based on the FAS and included participants who completed the 56-week trial period. The FAS included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle).

End point type

Secondary

End point timeframe

From baseline to 56 weeks

End point values	Liraglutide 3.0 mg	Placebo
Number of subjects analysed	105	100
Units: mmol/L
arithmetic mean (standard deviation)	-0.1 ( 0.5 )	-0.0 ( 0.6 )

No statistical analyses for this end point

Secondary: Number of treatment emergent adverse events

Top of page

End point title

Number of treatment emergent adverse events

End point description

A treatment emergent adverse event (TEAE) was defined as an event that occurred in the “on-treatment” period. ‘On-treatment’ period: Events with onset date between the first day of trial product administration and any of the following date, whichever came first: 1) 14 days after the last day on trial product, or 2) follow-up visit (week 58) for participants who discontinued trial product, or 3) last study visit (participants withdrawn without follow-up visit). Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product.

End point type

Secondary

End point timeframe

Week 0–56 + 14 days

End point values	Liraglutide 3.0 mg	Placebo
Number of subjects analysed	125	126
Units: Events	777	627

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

Week 0–56 + 14 days.

Adverse event reporting additional description

Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. All presented adverse events are TEAEs.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

Reporting group title

Liraglutide 3.0 mg

Reporting group description

Reporting group title

Placebo

Reporting group description

Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57–82).

Serious adverse events	Liraglutide 3.0 mg	Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	3 / 125 (2.40%)	5 / 126 (3.97%)
number of deaths (all causes)	1	0
number of deaths resulting from adverse events	0	0
Injury, poisoning and procedural complications
Post procedural haemorrhage
subjects affected / exposed	1 / 125 (0.80%)	0 / 126 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Thrombophlebitis
subjects affected / exposed	0 / 125 (0.00%)	1 / 126 (0.79%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
subjects affected / exposed	0 / 125 (0.00%)	1 / 126 (0.79%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Cholecystitis acute
subjects affected / exposed	0 / 125 (0.00%)	1 / 126 (0.79%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholelithiasis
subjects affected / exposed	0 / 125 (0.00%)	1 / 126 (0.79%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Completed suicide
subjects affected / exposed	1 / 125 (0.80%)	0 / 126 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Musculoskeletal and connective tissue disorders
Myositis
subjects affected / exposed	1 / 125 (0.80%)	0 / 126 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Appendicitis
subjects affected / exposed	0 / 125 (0.00%)	1 / 126 (0.79%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	0 / 125 (0.00%)	1 / 126 (0.79%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

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

Non-serious adverse events	Liraglutide 3.0 mg	Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	100 / 125 (80.00%)	84 / 126 (66.67%)
Nervous system disorders
Dizziness
subjects affected / exposed	13 / 125 (10.40%)	4 / 126 (3.17%)
occurrences all number	15	5
Headache
subjects affected / exposed	29 / 125 (23.20%)	35 / 126 (27.78%)
occurrences all number	43	53
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	10 / 125 (8.00%)	9 / 126 (7.14%)
occurrences all number	11	11
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	10 / 125 (8.00%)	11 / 126 (8.73%)
occurrences all number	15	15
Abdominal pain upper
subjects affected / exposed	17 / 125 (13.60%)	17 / 126 (13.49%)
occurrences all number	25	23
Diarrhoea
subjects affected / exposed	28 / 125 (22.40%)	18 / 126 (14.29%)
occurrences all number	44	29
Nausea
subjects affected / exposed	53 / 125 (42.40%)	18 / 126 (14.29%)
occurrences all number	101	25
Vomiting
subjects affected / exposed	43 / 125 (34.40%)	5 / 126 (3.97%)
occurrences all number	85	8
Reproductive system and breast disorders
Dysmenorrhoea
subjects affected / exposed	4 / 125 (3.20%)	8 / 126 (6.35%)
occurrences all number	5	16
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
subjects affected / exposed	11 / 125 (8.80%)	15 / 126 (11.90%)
occurrences all number	11	18
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	3 / 125 (2.40%)	8 / 126 (6.35%)
occurrences all number	3	8
Infections and infestations
Gastroenteritis
subjects affected / exposed	16 / 125 (12.80%)	6 / 126 (4.76%)
occurrences all number	22	9
Influenza
subjects affected / exposed	11 / 125 (8.80%)	12 / 126 (9.52%)
occurrences all number	11	12
Nasopharyngitis
subjects affected / exposed	34 / 125 (27.20%)	38 / 126 (30.16%)
occurrences all number	68	80
Pharyngitis
subjects affected / exposed	4 / 125 (3.20%)	7 / 126 (5.56%)
occurrences all number	5	7
Upper respiratory tract infection
subjects affected / exposed	11 / 125 (8.80%)	11 / 126 (8.73%)
occurrences all number	14	16

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:
Effect of liraglutide for weight management in pubertal adolescent subjects with obesity. 56-week, double-blind, randomised, parallel-group, placebo-controlled multi-national trial followed by a 26-week period off study-drug

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Change in body mass index (BMI) standard deviation score (SDS)

Primary: Change in body mass index (BMI) standard deviation score (SDS)

Secondary: Percent of subjects achieving ≥5% reduction in baseline BMI

Secondary: Percent of subjects achieving ≥5% reduction in baseline BMI

Secondary: Percent of subjects achieving ≥10% reduction in baseline BMI

Secondary: Percent of subjects achieving ≥10% reduction in baseline BMI

Secondary: Change in BMI from baseline to 56 weeks

Secondary: Change in BMI from baseline to 56 weeks

Secondary: Change in body weight (kilogram [kg]) from baseline to 56 weeks

Secondary: Change in body weight (kilogram [kg]) from baseline to 56 weeks

Secondary: Change in body weight (pounds [lb]) from baseline to 56 weeks

Secondary: Change in body weight (pounds [lb]) from baseline to 56 weeks

Secondary: Change in body weight (percent [%]) from baseline to 56 weeks

Secondary: Change in body weight (percent [%]) from baseline to 56 weeks

Secondary: Change in systolic and diastolic blood pressure

Secondary: Change in systolic and diastolic blood pressure

Secondary: Change in glycosylated haemoglobin (HbA1c)

Secondary: Change in glycosylated haemoglobin (HbA1c)

Secondary: Change in fasting plasma glucose

Secondary: Change in fasting plasma glucose

Secondary: Number of treatment emergent adverse events

Secondary: Number of treatment emergent adverse events

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: Effect of liraglutide for weight management in pubertal adolescent subjects with obesity. 56-week, double-blind, randomised, parallel-group, placebo-controlled multi-national trial followed by a 26-week period off study-drug

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Change in body mass index (BMI) standard deviation score (SDS)

Primary: Change in body mass index (BMI) standard deviation score (SDS)

Secondary: Percent of subjects achieving ≥5% reduction in baseline BMI

Secondary: Percent of subjects achieving ≥5% reduction in baseline BMI

Secondary: Percent of subjects achieving ≥10% reduction in baseline BMI

Secondary: Percent of subjects achieving ≥10% reduction in baseline BMI

Secondary: Change in BMI from baseline to 56 weeks

Secondary: Change in BMI from baseline to 56 weeks

Secondary: Change in body weight (kilogram [kg]) from baseline to 56 weeks

Secondary: Change in body weight (kilogram [kg]) from baseline to 56 weeks

Secondary: Change in body weight (pounds [lb]) from baseline to 56 weeks

Secondary: Change in body weight (pounds [lb]) from baseline to 56 weeks

Secondary: Change in body weight (percent [%]) from baseline to 56 weeks

Secondary: Change in body weight (percent [%]) from baseline to 56 weeks

Secondary: Change in systolic and diastolic blood pressure

Secondary: Change in systolic and diastolic blood pressure

Secondary: Change in glycosylated haemoglobin (HbA1c)

Secondary: Change in glycosylated haemoglobin (HbA1c)

Secondary: Change in fasting plasma glucose

Secondary: Change in fasting plasma glucose

Secondary: Number of treatment emergent adverse events

Secondary: Number of treatment emergent adverse events

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
Effect of liraglutide for weight management in pubertal adolescent subjects with obesity. 56-week, double-blind, randomised, parallel-group, placebo-controlled multi-national trial followed by a 26-week period off study-drug