Clinical Trial Results:
A Double-Blind, Placebo-Controlled, Cross-over Phase II Study to Evaluate the Effect of a 6-week Elafibranor (120mg) treatment administered once daily on hepatic lipid composition in subjects with Nonalcoholic Fatty Liver (NAFL).
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Summary
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EudraCT number |
2019-000645-12 |
Trial protocol |
NL |
Global end of trial date |
14 Jul 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
24 Nov 2021
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First version publication date |
24 Nov 2021
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
GFT505-219-8
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03953456 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
GENFIT
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Sponsor organisation address |
Parc Eurasanté, 885, Avenue Eugène Avinée, Loos, France, 59120
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Public contact |
clinicaltrial@genfit.com , GENFIT, +33 320164038,
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Scientific contact |
Carol Addy, MD MMSc, GENFIT, +01 6179536469,
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
14 Jul 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
14 Jul 2020
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Global end of trial reached? |
Yes
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Global end of trial date |
14 Jul 2020
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
The primary objective was to evaluate the effect of a 6-week treatment with elafibranor versus placebo on hepatic lipid composition in subjects with a fatty liver.
The secondary objectives were to evaluate the between-treatment difference (elafibranor 120 mg/day vs. placebo) in hepatic glucose production (HGP) measured at the end of 6 weeks of treatment, and to compare the changes from baseline achieved after 6 weeks of treatment with elafibranor 120 mg/day versus placebo in glucose homeostasis, lipid metabolism, inflammatory markers, liver function, renal function and anthropometry.
The safety objectives were to assess the safety and tolerability profile of 6 weeks elafibranor administration orally (120 mg/day) in NAFL subjects in terms of serious adverse events (SAE), adverse events (AE), vital signs, haematological parameters, liver markers, renal biomarkers, metabolic parameters and other biochemical safety markers.
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Protection of trial subjects |
This study was conducted in accordance with Good Clinical Practice standards, ethical principles stated in the Declaration of Helsinki and applicable regulatory requirements. After the subject has ended his/her participation in the trial, the investigator provided appropriate medication and/or arranged access to appropriate care for the patient.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
20 Aug 2019
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Netherlands: 17
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Worldwide total number of subjects |
17
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EEA total number of subjects |
17
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
5
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From 65 to 84 years |
12
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85 years and over |
0
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Recruitment
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Recruitment details |
A liver fat percentage (intrahepatic lipid [IHL]) of ≥5% as determined with magnetic resonance spectroscopy (1H-MRS), body mass index (BMI) between 25 and 38 kg/m2, and age between 40 and 75 years. | |||||||||||||||
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Pre-assignment
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Screening details |
A total of 36 subjects were screened for the study: 19 subjects were screen failures (18 subjects did not meet the study eligibility criteria and 1 subject had low quality 1H-MRS data that made determination of liver fat composition not possible) and 17 subjects were eligible and randomised. | |||||||||||||||
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Period 1
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Period 1 title |
overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||
Roles blinded |
Subject, Investigator, Monitor | |||||||||||||||
Blinding implementation details |
A randomisation list was generated by a random number system. Individual randomisation code referred to either of the two sequence groups: sequence Group A: placebo first followed by elafibranor 120mg, sequence Group B: elafibranor 120mg first followed by placebo. The subjects who successfully passed screening were assigned an individual randomisation code and randomly allocated to one of the two sequence groups (A or B).
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Arms
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Are arms mutually exclusive |
No
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Arm title
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Elafibranor 120 mg | |||||||||||||||
Arm description |
Elafibranor 120 mg tablet qd | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Elafibranor
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Investigational medicinal product code |
GFT505
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Elafibranor 120 mg was administered orally to study subjects once daily for 6 weeks.
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Arm title
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Placebo | |||||||||||||||
Arm description |
Matched placebo tablet qd | |||||||||||||||
Arm type |
Placebo | |||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
-
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Other name |
-
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Placebo was administered orally to study subjects once daily for 6 weeks.
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Baseline characteristics reporting groups
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Reporting group title |
overall trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
ITT set
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Subject analysis set type |
Intention-to-treat | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All the subjects that were randomized.
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Subject analysis set title |
PP set
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Subject analysis set type |
Per protocol | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All randomized subjects who completed the study without any major protocol deviation affecting the primary efficacy endpoint.
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Subject analysis set title |
Safety set
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Subject analysis set type |
Safety analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All subjects who received at least one dose of study treatment.
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End points reporting groups
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Reporting group title |
Elafibranor 120 mg
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Reporting group description |
Elafibranor 120 mg tablet qd | ||
Reporting group title |
Placebo
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Reporting group description |
Matched placebo tablet qd | ||
Subject analysis set title |
ITT set
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
All the subjects that were randomized.
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Subject analysis set title |
PP set
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
All randomized subjects who completed the study without any major protocol deviation affecting the primary efficacy endpoint.
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Subject analysis set title |
Safety set
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
All subjects who received at least one dose of study treatment.
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End point title |
relative amount of saturated fatty acid in the liver (%SFA) at the end of each 6-week treatment period [1] | ||||||||||||
End point description |
The primary endpoint was the relative amount of SFA in the liver (%SFA) measured by 1H-MRS at the end of each 6-week treatment period.
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End point type |
Primary
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End point timeframe |
Visit 3 and Visit 6
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
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| Notes [2] - analysis not performed due to lack of data [3] - analysis not performed due to lack of data |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change from baseline achieved after 6 weeks of treatment in Polyunsaturated Fatty Acids (PUFA) [4] | ||||||||||||||||||||
End point description |
Secondary endpoints were measured at the end of each of the 6-week treatment periods
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End point type |
Primary
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End point timeframe |
Visit 3 and Visit 6
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
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| Notes [5] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [6] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [7] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [8] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Change from baseline achieved after 6 weeks of treatment in Monounsaturated Fatty Acids (MUFA) [9] | ||||||||||||||||||||
End point description |
Secondary endpoints were measured at the end of each of the 6-week treatment periods
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End point type |
Primary
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End point timeframe |
Visit 3 and Visit 6
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| Notes [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
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| Notes [10] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [11] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [12] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [13] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Change from baseline achieved after 6 weeks of treatment in Saturated Fatty Acids (SFA) [14] | ||||||||||||||||||||
End point description |
Secondary endpoints were measured at the end of each of the 6-week treatment periods
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End point type |
Primary
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End point timeframe |
Visit 3 and Visit 6
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| Notes [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
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| Notes [15] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [16] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [17] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [18] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Change from baseline achieved after 6 weeks of treatment in MRS liver fat fraction ( %Fat w/w) [19] | ||||||||||||||||||||
End point description |
Secondary endpoints were measured at the end of each of the 6-week treatment periods
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End point type |
Primary
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End point timeframe |
Visit 3 and Visit 6
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| Notes [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
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| Notes [20] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [21] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [22] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [23] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Hepatic Glucose Production (HGP) at the end of each 6-week treatment period | ||||||||||||||||||||
End point description |
Hepatic glucose production at the end of each 6-week treatment period was used as a measure of hepatic insulin sensitivity.
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End point type |
Secondary
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End point timeframe |
Visit 3 and Visit 6
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| Notes [24] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [25] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [26] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [27] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Change from baseline achieved after 6 weeks of treatment in HbA1c | ||||||||||||||||||||
End point description |
Secondary endpoints were measured at the end of each of the 6-week treatment periods
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End point type |
Secondary
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End point timeframe |
Visit 3 and Visit 6
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| Notes [28] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [29] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [30] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [31] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Change from baseline achieved after 6 weeks of treatment in fasting plasma glucose (FPG) | ||||||||||||||||||||
End point description |
Secondary endpoints were measured at the end of each of the 6-week treatment periods
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End point type |
Secondary
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End point timeframe |
Visit 3 and Visit 6
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| Notes [32] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [33] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [34] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [35] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Change from baseline achieved after 6 weeks of treatment in fasting insulin | ||||||||||||||||||||
End point description |
Secondary endpoints were measured at the end of each of the 6-week treatment periods
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End point type |
Secondary
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End point timeframe |
Visit 3 and Visit 6
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|
|||||||||||||||||||||
| Notes [36] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [37] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [38] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [39] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
Change from baseline achieved after 6 weeks of treatment in HOMA-IR | ||||||||||||||||||||
End point description |
HOMA-IR: homeostasis model assessment of insulin resistance
Secondary endpoints were measured at the end of each of the 6-week treatment periods
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Visit 3 and Visit 6
|
||||||||||||||||||||
|
|||||||||||||||||||||
| Notes [40] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [41] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [42] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [43] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
Change from baseline achieved after 6 weeks of treatment in fructosamine | ||||||||||||||||||||
End point description |
Secondary endpoints were measured at the end of each of the 6-week treatment periods
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Visit 3 and Visit 6
|
||||||||||||||||||||
|
|||||||||||||||||||||
| Notes [44] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [45] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [46] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [47] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
Change from baseline achieved after 6 weeks of treatment in C-peptide | ||||||||||||||||||||
End point description |
Secondary endpoints were measured at the end of each of the 6-week treatment periods
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Visit 3 and Visit 6
|
||||||||||||||||||||
|
|||||||||||||||||||||
| Notes [48] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [49] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [50] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [51] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
Change from baseline achieved after 6 weeks of treatment in total cholesterol | ||||||||||||||||||||
End point description |
Secondary endpoints were measured at the end of each of the 6-week treatment periods
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Visit 3 and Visit 6
|
||||||||||||||||||||
|
|||||||||||||||||||||
| Notes [52] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [53] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [54] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [55] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
Change from baseline achieved after 6 weeks of treatment in HDL cholesterol (HDL-C) | ||||||||||||||||||||
End point description |
HDL: high density lioprotein
Secondary endpoints were measured at the end of each of the 6-week treatment periods
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Visit 3 and Visit 6
|
||||||||||||||||||||
|
|||||||||||||||||||||
| Notes [56] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [57] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [58] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [59] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
Change from baseline achieved after 6 weeks of treatment in non-HDL cholesterol | ||||||||||||||||||||
End point description |
Secondary endpoints were measured at the end of each of the 6-week treatment periods
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Visit 3 and Visit 6
|
||||||||||||||||||||
|
|||||||||||||||||||||
| Notes [60] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [61] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [62] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [63] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
Change from baseline achieved after 6 weeks of treatment in LDL cholesterol (calculated) | ||||||||||||||||||||
End point description |
LDL: low density lipoprotein
Secondary endpoints were measured at the end of each of the 6-week treatment periods
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Visit 3 and Visit 6
|
||||||||||||||||||||
|
|||||||||||||||||||||
| Notes [64] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [65] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [66] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [67] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
Change from baseline achieved after 6 weeks of treatment in fasting triglycerides | ||||||||||||||||||||
End point description |
Secondary endpoints were measured at the end of each of the 6-week treatment periods
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Visit 3 and Visit 6
|
||||||||||||||||||||
|
|||||||||||||||||||||
| Notes [68] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [69] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [70] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [71] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
Change from baseline achieved after 6 weeks of treatment in free fatty acid | ||||||||||||||||||||
End point description |
Secondary endpoints were measured at the end of each of the 6-week treatment periods
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Visit 3 and Visit 6
|
||||||||||||||||||||
|
|||||||||||||||||||||
| Notes [72] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [73] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [74] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [75] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
Change from baseline achieved after 6 weeks of treatment in high-sensitivity C-reactive protein hsCRP | ||||||||||||||||||||
End point description |
hs-CRP: high sensitivity C-reactive protein
Secondary endpoints were measured at the end of each of the 6-week treatment periods
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Visit 3 and Visit 6
|
||||||||||||||||||||
|
|||||||||||||||||||||
| Notes [76] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [77] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [78] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [79] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
Change from baseline achieved after 6 weeks of treatment in fibrinogen | ||||||||||||||||||||
End point description |
Secondary endpoints were measured at the end of each of the 6-week treatment periods
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Visit 3 and Visit 6
|
||||||||||||||||||||
|
|||||||||||||||||||||
| Notes [80] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [81] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [82] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [83] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
Change from baseline achieved after 6 weeks of treatment in haptoglobin | ||||||||||||||||||||
End point description |
Secondary endpoints were measured at the end of each of the 6-week treatment periods
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Visit 3 and Visit 6
|
||||||||||||||||||||
|
|||||||||||||||||||||
| Notes [84] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [85] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [86] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [87] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
Change from baseline achieved after 6 weeks of treatment in gamma-glutamyl transferase (GGT) | ||||||||||||||||||||
End point description |
Secondary endpoints were measured at the end of each of the 6-week treatment periods
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Visit 3 and Visit 6
|
||||||||||||||||||||
|
|||||||||||||||||||||
| Notes [88] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [89] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [90] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [91] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
Change from baseline achieved after 6 weeks of treatment in aspartate aminotransferase (AST) | ||||||||||||||||||||
End point description |
Secondary endpoints were measured at the end of each of the 6-week treatment periods
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Visit 3 and Visit 6
|
||||||||||||||||||||
|
|||||||||||||||||||||
| Notes [92] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [93] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [94] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [95] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
Change from baseline achieved after 6 weeks of treatment in alanine aminotransferase (ALT) | ||||||||||||||||||||
End point description |
Secondary endpoints were measured at the end of each of the 6-week treatment periods
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Visit 3 and Visit 6
|
||||||||||||||||||||
|
|||||||||||||||||||||
| Notes [96] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [97] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [98] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [99] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
Change from baseline achieved after 6 weeks of treatment in alkaline phosphatase | ||||||||||||||||||||
End point description |
Secondary endpoints were measured at the end of each of the 6-week treatment periods
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Visit 3 and Visit 6
|
||||||||||||||||||||
|
|||||||||||||||||||||
| Notes [100] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [101] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [102] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [103] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
Change from baseline achieved after 6 weeks of treatment in total bilirubin | ||||||||||||||||||||
End point description |
Secondary endpoints were measured at the end of each of the 6-week treatment periods
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Visit 3 and Visit 6
|
||||||||||||||||||||
|
|||||||||||||||||||||
| Notes [104] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [105] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [106] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [107] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
Change from baseline achieved after 6 weeks of treatment in conjugated bilirubin | ||||||||||||||||||||
End point description |
Secondary endpoints were measured at the end of each of the 6-week treatment periods
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Visit 3 and Visit 6
|
||||||||||||||||||||
|
|||||||||||||||||||||
| Notes [108] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [109] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [110] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [111] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
Change from baseline achieved after 6 weeks of treatment in serum creatinine | ||||||||||||||||||||
End point description |
Secondary endpoints were measured at the end of each of the 6-week treatment periods
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Visit 3 and Visit 6
|
||||||||||||||||||||
|
|||||||||||||||||||||
| Notes [112] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [113] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [114] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [115] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
Change from baseline achieved after 6 weeks of treatment in eGFR | ||||||||||||||||||||
End point description |
eGFR, i.e. estimated glomerular filtration rate, was calculated according to the MDRD (Modification of Diet in Renal Disease) equation.
Secondary endpoints were measured at the end of each of the 6-week treatment periods
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Visit 3 and Visit 6
|
||||||||||||||||||||
|
|||||||||||||||||||||
| Notes [116] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [117] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [118] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [119] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
Change from baseline achieved after 6 weeks of treatment in albumin | ||||||||||||||||||||
End point description |
Secondary endpoints were measured at the end of each of the 6-week treatment periods
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Visit 3 and Visit 6
|
||||||||||||||||||||
|
|||||||||||||||||||||
| Notes [120] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [121] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [122] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [123] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
Change from baseline achieved after 6 weeks of treatment in total protein | ||||||||||||||||||||
End point description |
Secondary endpoints were measured at the end of each of the 6-week treatment periods
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Visit 3 and Visit 6
|
||||||||||||||||||||
|
|||||||||||||||||||||
| Notes [124] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [125] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [126] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [127] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
Change from baseline achieved after 6 weeks of treatment in urea (BUN) | ||||||||||||||||||||
End point description |
Urea: blood urea nitrogen
Secondary endpoints were measured at the end of each of the 6-week treatment periods
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Visit 3 and Visit 6
|
||||||||||||||||||||
|
|||||||||||||||||||||
| Notes [128] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [129] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [130] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [131] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
Change from baseline achieved after 6 weeks of treatment in uric acid | ||||||||||||||||||||
End point description |
Secondary endpoints were measured at the end of each of the 6-week treatment periods
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Visit 3 and Visit 6
|
||||||||||||||||||||
|
|||||||||||||||||||||
| Notes [132] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [133] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [134] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [135] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
Change from baseline achieved after 6 weeks of treatment in body weight | ||||||||||||||||||||
End point description |
Secondary endpoints were measured at the end of each of the 6-week treatment periods
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Visit 3 and Visit 6
|
||||||||||||||||||||
|
|||||||||||||||||||||
| Notes [136] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [137] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [138] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [139] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
Change from baseline achieved after 6 weeks of treatment in Body Mass Index (BMI) | ||||||||||||||||||||
End point description |
Secondary endpoints were measured at the end of each of the 6-week treatment periods
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Visit 3 and Visit 6
|
||||||||||||||||||||
|
|||||||||||||||||||||
| Notes [140] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [141] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [142] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [143] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
Waist circumference Change from baseline at the end of each 6-week treatment period | ||||||||||||||||||||
End point description |
Secondary endpoints were measured at the end of each of the 6-week treatment periods
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Visit 3 and Visit 6
|
||||||||||||||||||||
|
|||||||||||||||||||||
| Notes [144] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [145] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [146] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. [147] - No efficacy analyses produced as the number of subjects who completed the study was insufficient. |
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
||||||||||
End point title |
incidence of clinically significant hematology parameter abnormality | |||||||||
End point description |
abnormalities considered clinically significant by the PI.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
from the first screening visit until Visit 6 of the second treatment period
|
|||||||||
|
||||||||||
| No statistical analyses for this end point | ||||||||||
|
||||||||||
End point title |
incidence of clinically significant chemistry, liver function and renal function parameter abnormality | |||||||||
End point description |
abnormalities considered clinically significant by the PI
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
from the first screening visit until Visit 6 of the second treatment period
|
|||||||||
|
||||||||||
| No statistical analyses for this end point | ||||||||||
|
||||||||||
End point title |
incidence of clinically significant vital signs abnormality | |||||||||
End point description |
abnormalities considered clinically significant by the PI
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
from the first screening visit until Visit 6 of the second treatment period
|
|||||||||
|
||||||||||
| No statistical analyses for this end point | ||||||||||
|
||||||||||
End point title |
incidence of clinically significant change in diet | |||||||||
End point description |
changes considered clinically significant by the PI
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
from the first screening visit until Visit 6 of the second treatment period
|
|||||||||
|
||||||||||
| No statistical analyses for this end point | ||||||||||
|
||||||||||
End point title |
incidence of clinically significant change in alcohol consumption | |||||||||
End point description |
changes considered clinically significant by the PI
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
from the first screening visit until Visit 6 of the second treatment period
|
|||||||||
|
||||||||||
| No statistical analyses for this end point | ||||||||||
|
||||||||||
End point title |
incidence of clinically significant change in physical activity | |||||||||
End point description |
changes considered clinically significant by the PI
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
from the first screening visit until Visit 6 of the second treatment period
|
|||||||||
|
||||||||||
| No statistical analyses for this end point | ||||||||||
|
||||||||||
End point title |
incidence of strenuous and unusual exercise | |||||||||
End point description |
||||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
from the first screening visit until Visit 6 of the second treatment period
|
|||||||||
|
||||||||||
| No statistical analyses for this end point | ||||||||||
|
|||||||
End point title |
Incidence of adverse events | ||||||
End point description |
|||||||
End point type |
Secondary
|
||||||
End point timeframe |
from signature of the subject ICF at the first Screening Visit until the end of study visit
|
||||||
|
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||
End point title |
Incidence of treatment emergent adverse event | ||||||
End point description |
|||||||
End point type |
Secondary
|
||||||
End point timeframe |
from signature of the subject ICF at the first Screening Visit until the end of study visit
|
||||||
|
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||
End point title |
Incidence of treatment emergent adverse events related to study treatment | ||||||
End point description |
|||||||
End point type |
Secondary
|
||||||
End point timeframe |
from signature of the subject ICF at the first Screening Visit until the end of study visit
|
||||||
|
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||
End point title |
Incidence of treatment emergent adverse events related to study procedures | ||||||
End point description |
|||||||
End point type |
Secondary
|
||||||
End point timeframe |
from signature of the subject ICF at the first Screening Visit until the end of study visit
|
||||||
|
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||
End point title |
Incidence of serious adverse events | ||||||
End point description |
|||||||
End point type |
Secondary
|
||||||
End point timeframe |
from signature of the subject ICF at the first Screening Visit until the end of study visit
|
||||||
|
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||
End point title |
Incidence of serious treatment emergent adverse events | ||||||
End point description |
|||||||
End point type |
Secondary
|
||||||
End point timeframe |
from signature of the subject ICF at the first Screening Visit until the end of study visit
|
||||||
|
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||
End point title |
Incidence of serious treatment emergent adverse events related to study treatment | ||||||
End point description |
|||||||
End point type |
Secondary
|
||||||
End point timeframe |
from signature of the subject ICF at the first Screening Visit until the end of study visit
|
||||||
|
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||
End point title |
Incidence of serious treatment emergent adverse events related to study procedure | ||||||
End point description |
|||||||
End point type |
Secondary
|
||||||
End point timeframe |
from signature of the subject ICF at the first Screening Visit until the end of study visit
|
||||||
|
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||
End point title |
Incidence of adverse events leading to treatment withdrawal | ||||||
End point description |
|||||||
End point type |
Secondary
|
||||||
End point timeframe |
from signature of the subject ICF at the first Screening Visit until the end of study visit
|
||||||
|
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||
End point title |
Incidence of treatment emergent adverse event leading to treatment withdrawal | ||||||
End point description |
|||||||
End point type |
Secondary
|
||||||
End point timeframe |
from signature of the subject ICF at the first Screening Visit until the end of study visit
|
||||||
|
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||
End point title |
Incidence of adverse events leading to study withdrawal | ||||||
End point description |
|||||||
End point type |
Secondary
|
||||||
End point timeframe |
from signature of the subject ICF at the first Screening Visit until the end of study visit
|
||||||
|
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||
End point title |
Incidence of treatment emergent adverse events leading to study withdrawal | ||||||
End point description |
|||||||
End point type |
Secondary
|
||||||
End point timeframe |
from signature of the subject ICF at the first Screening Visit until the end of study visit
|
||||||
|
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||
End point title |
Incidence of fatal adverse events | ||||||
End point description |
|||||||
End point type |
Secondary
|
||||||
End point timeframe |
from signature of the subject ICF at the first Screening Visit until the end of study visit
|
||||||
|
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||
End point title |
Incidence of fatal treatment emergent adverse event | ||||||
End point description |
|||||||
End point type |
Secondary
|
||||||
End point timeframe |
from signature of the subject ICF at the first Screening Visit until the end of study visit
|
||||||
|
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||
End point title |
Incidence of adverse events of special interest | ||||||
End point description |
AESI are TEAEs corresponding to the conceptual definition of:
CPK elevations of severe intensity or leading to permanent study drug discontinuation;
Muscle injury symptoms of severe intensity corresponding to muscle pain or myalgia, Muscle spasms or tremor, muscle weakness;
Transaminases elevations from baseline of severe intensity or leading to permanent study drug discontinuation;
Liver injury events of severe intensity corresponding to hepatic impairment, hepatic failure;
Gastrointestinal symptoms of severe intensity corresponding to abdominal pain, constipation, diarrhea, nausea, vomiting, acute cholecystis, acute pancreatitis;
Fatigue and asthenia of severe intensity;
Serum creatinine elevations of severe intensity or leading to permanent study drug
discontinuation;
Renal injury events of moderate or severe intensity corresponding to renal failure, renal impairment, renal colic.
|
||||||
End point type |
Secondary
|
||||||
End point timeframe |
from signature of the subject ICF at the first Screening Visit until the end of study visit
|
||||||
|
|||||||
| No statistical analyses for this end point | |||||||
|
||||||||||
End point title |
Incidence of clinically significant change in smoking habits | |||||||||
End point description |
||||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
from the first screening visit until Visit 6 of the second treatment period
|
|||||||||
|
||||||||||
| No statistical analyses for this end point | ||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
from signature of the subject ICF at the first Screening Visit until the end of study visit
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
23.0
|
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|
Reporting groups
|
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Reporting group title |
Overall population
|
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||
Substantial protocol amendments (globally) |
|||||||
| Were there any global substantial amendments to the protocol? Yes | |||||||
Date |
Amendment |
||||||
16 Dec 2019 |
The protocol was amended in order to add an analysis set and update a series of endpoints.
The changes mainly concerned:
Specification of a PP set to be included for analysis purposes; inclusion of renal function and anthropometry as objectives, in line with existing endpoints; medical history was removed as a safety objective and safety endpoints were presented in more detail; specification that whole body insulin sensitivity rather than glucose infusion rate at the end of 6 weeks of treatment would be assessed as an exploratory objective and endpoint, with details of assessment parameters included; specification that waist circumference was to be assessed at the end of each 6-week treatment period, rather than as change from baseline; clarification of various other endpoints.
|
||||||
Interruptions (globally) |
|||||||
| Were there any global interruptions to the trial? Yes | |||||||
|
|||||||
Limitations and caveats |
|||||||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||||||
| Due to the premature termination of this study no efficacy analyses were conducted since too few subjects completed both study periods. As such the efficacy objectives were not met and no conclusions can be drawn from the efficacy data. | |||||||
