A 6-month randomized, double-blind, placebo-controlled trial of weekly exenatide in adolescents with obesity.

Weghuber D, Forslund A, Ahlström H, Alderborn A, Bergström K, Brunner S, Cadamuro J, Ciba I, Dahlbom M, Heu V, Hofmann J, Kristinsson H and 13 more

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Kullberg J, Ladinger A, Lagler FB, Lidström M, Manell H, Meirik M, Mörwald K, Roomp K, Schneider R, Vilén H, Widhalm K, Zsoldos F, Bergsten P

Pediatric obesity16 Feb 2020Cited by 68 (Europe PMC)

PMID32062862DOI10.1111/ijpo.12624PepBankPUB-32062862

Publisher page PubMedAsk about this study

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Summary

BackgroundPharmacological treatment options for adolescents with obesity are very limited. Glucagon-like-peptide-1 (GLP-1) receptor agonist could be a treatment option for adolescent obesity.ObjectiveTo investigate the effect of exenatide extended release on body mass index (BMI)-SDS as primary outcome, and glucose metabolism, cardiometabolic risk factors, liver steatosis, and other BMI metrics as secondary outcomes, and its safety and tolerability in adolescents with obesity.MethodsSix-month, randomized, double-blinded, parallel, placebo-controlled clinical trial in patients (n = 44, 10-18 years, females n = 22) with BMI-SDS > 2.0 or age-adapted-BMI > 30 kg/m² according to WHO were included. Patients received lifestyle intervention and were randomized to exenatide extended release 2 mg (n = 22) or placebo (n = 22) subcutaneous injections given once weekly. Oral glucose tolerance tests (OGTT) were conducted at the beginning and end of the intervention.ResultsExenatide reduced (P < .05) BMI-SDS (-0.09; -0.18, 0.00), % BMI 95th percentile (-2.9%; -5.4, -0.3), weight (-3 kg; -5.8, -0.1), waist circumference (-3.2 cm; -5.8, -0.7), subcutaneous adipose tissue (-552 cm³ ; -989, -114), 2-hour-glucose during OGTT (-15.3 mg/dL; -27.5, -3.1), total cholesterol (11.6 mg/dL; -21.7, -1.5), and BMI (-0.83 kg/m² ; -1.68, 0.01) without significant change in liver fat content (-1.36; -3.12, 0.4; P = .06) in comparison to placebo. Safety and tolerability profiles were comparable to placebo with the exception of mild adverse events being more frequent in exenatide-treated patients.ConclusionsTreatment of adolescents with severe obesity with extended-release exenatide is generally well tolerated and leads to a modest reduction in BMI metrics and improvement in glucose tolerance and cholesterol. The study indicates that the treatment provides additional beneficial effects beyond BMI reduction for the patient group.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study11

11 results from studies that gave the peptide. 11 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adolescents with obesity, exenatide reduced BMI-SDS versus placebo.
In plain wordsIn adolescents with obesity, exenatide reduced BMI-SDS more than placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseBMI-SDS
Study
n = 44
Comparator
Placebo
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
2 mg once weekly · subcutaneous · 6 monthsAs given in this study (human).
Measurements
BMI-SDS difference
−0.09 BMI-SDS
versus placebo
Source sentences
Summary
Exenatide reduced (P < .05) BMI-SDS (-0.09; -0.18, 0.00)
2 context sentences(design, population, supporting numbers)
Summary · context
Six-month, randomized, double-blinded, parallel, placebo-controlled clinical trial in patients (n = 44, 10-18 years, females n = 22) with BMI-SDS > 2.0 or age-adapted-BMI > 30 kg/m² according to WHO were included.
Summary · context
Patients received lifestyle intervention and were randomized to exenatide extended release 2 mg (n = 22) or placebo (n = 22) subcutaneous injections given once weekly.
Show in the study text Report a problemFND-3206286201
02HumanRandomized controlled trialEfficacy outcome
In adolescents with obesity, exenatide reduced percent BMI of the 95th percentile versus placebo.
In plain wordsIn adolescents with obesity, exenatide reduced percent BMI of the 95th percentile more than placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseBMI 95th percentile percentage
Study
n = 44
Comparator
Placebo
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
2 mg once weekly · subcutaneous · 6 monthsAs given in this study (human).
Measurements
BMI 95th percentile difference
−2.9%
versus placebo
Source sentences
Summary
% BMI 95th percentile (-2.9%; -5.4, -0.3)
2 context sentences(design, population, supporting numbers)
Summary · context
Six-month, randomized, double-blinded, parallel, placebo-controlled clinical trial in patients (n = 44, 10-18 years, females n = 22) with BMI-SDS > 2.0 or age-adapted-BMI > 30 kg/m² according to WHO were included.
Summary · context
Patients received lifestyle intervention and were randomized to exenatide extended release 2 mg (n = 22) or placebo (n = 22) subcutaneous injections given once weekly.
Show in the study text Report a problemFND-3206286202
03HumanRandomized controlled trialEfficacy outcome
In adolescents with obesity, exenatide reduced two-hour OGTT glucose versus placebo.
In plain wordsIn adolescents with obesity, exenatide reduced glucose after a glucose drink more than placebo.
Peptide
Exenatide (exendin-4)
Outcome
Decrease2-hour OGTT glucose
Study
n = 44
Comparator
Placebo
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2 mg once weekly · subcutaneous · 6 monthsAs given in this study (human).
Measurements
2-hour OGTT glucose difference
−15.3 mg/dL
versus placebo
Source sentences
Summary
2-hour-glucose during OGTT (-15.3 mg/dL; -27.5, -3.1)
2 context sentences(design, population, supporting numbers)
Summary · context
Six-month, randomized, double-blinded, parallel, placebo-controlled clinical trial in patients (n = 44, 10-18 years, females n = 22) with BMI-SDS > 2.0 or age-adapted-BMI > 30 kg/m² according to WHO were included.
Summary · context
Patients received lifestyle intervention and were randomized to exenatide extended release 2 mg (n = 22) or placebo (n = 22) subcutaneous injections given once weekly.
Show in the study text Report a problemFND-3206286206
04HumanRandomized controlled trialEfficacy outcome
In adolescents with obesity, the abstract reports reduced total cholesterol with exenatide versus placebo.
In plain wordsIn adolescents with obesity, the abstract reports lower cholesterol with exenatide than placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseTotal cholesterol
Study
n = 44
Comparator
Placebo
Analysis
Secondary
Outcome group
Lipids · Metabolic and weight
Studied dose
2 mg once weekly · subcutaneous · 6 monthsAs given in this study (human).
Measurements
Total cholesterol difference
11.6 mg/dL
versus placebo; value printed without a minus sign, interval -21.7 to -1.5
Source sentences
Summary
total cholesterol (11.6 mg/dL; -21.7, -1.5)
2 context sentences(design, population, supporting numbers)
Summary · context
Six-month, randomized, double-blinded, parallel, placebo-controlled clinical trial in patients (n = 44, 10-18 years, females n = 22) with BMI-SDS > 2.0 or age-adapted-BMI > 30 kg/m² according to WHO were included.
Summary · context
Patients received lifestyle intervention and were randomized to exenatide extended release 2 mg (n = 22) or placebo (n = 22) subcutaneous injections given once weekly.
Show in the study text Report a problemFND-3206286207
05HumanRandomized controlled trialEfficacy outcome
In adolescents with obesity, the abstract reports reduced BMI with exenatide versus placebo.
In plain wordsIn adolescents with obesity, the abstract reports lower BMI with exenatide than placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseBMI
Study
n = 44
Comparator
Placebo
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
2 mg once weekly · subcutaneous · 6 monthsAs given in this study (human).
Measurements
BMI difference
−0.83 kg/m<sup>2</sup>
versus placebo
Source sentences
Summary
BMI (-0.83 kg/m² ; -1.68, 0.01)
2 context sentences(design, population, supporting numbers)
Summary · context
Six-month, randomized, double-blinded, parallel, placebo-controlled clinical trial in patients (n = 44, 10-18 years, females n = 22) with BMI-SDS > 2.0 or age-adapted-BMI > 30 kg/m² according to WHO were included.
Summary · context
Patients received lifestyle intervention and were randomized to exenatide extended release 2 mg (n = 22) or placebo (n = 22) subcutaneous injections given once weekly.
Show in the study text Report a problemFND-3206286208
06HumanRandomized controlled trialEfficacy outcome
In adolescents with obesity, exenatide did not significantly change liver fat content versus placebo.
In plain wordsIn adolescents with obesity, liver fat did not differ significantly between exenatide and placebo.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeLiver fat content
Study
n = 44
Comparator
Placebo
Analysis
Secondary
Outcome group
Liver fat and liver function · Liver
Studied dose
2 mg once weekly · subcutaneous · 6 monthsAs given in this study (human).
Measurements
Liver fat content difference
−1.36 not stated in source
versus placebo; P = .06
Source sentences
Summary
without significant change in liver fat content (-1.36; -3.12, 0.4; P = .06) in comparison to placebo.
2 context sentences(design, population, supporting numbers)
Summary · context
Six-month, randomized, double-blinded, parallel, placebo-controlled clinical trial in patients (n = 44, 10-18 years, females n = 22) with BMI-SDS > 2.0 or age-adapted-BMI > 30 kg/m² according to WHO were included.
Summary · context
Patients received lifestyle intervention and were randomized to exenatide extended release 2 mg (n = 22) or placebo (n = 22) subcutaneous injections given once weekly.
Show in the study text Report a problemFND-3206286209
07HumanRandomized controlled trialEfficacy outcome
In adolescents with obesity, exenatide reduced weight versus placebo.
In plain wordsIn adolescents with obesity, exenatide reduced weight more than placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseWeight
Study
n = 44
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
2 mg once weekly · subcutaneous · 6 monthsAs given in this study (human).
Measurements
Weight difference
−3 kg
versus placebo
Source sentences
Summary
weight (-3 kg; -5.8, -0.1)
2 context sentences(design, population, supporting numbers)
Summary · context
Six-month, randomized, double-blinded, parallel, placebo-controlled clinical trial in patients (n = 44, 10-18 years, females n = 22) with BMI-SDS > 2.0 or age-adapted-BMI > 30 kg/m² according to WHO were included.
Summary · context
Patients received lifestyle intervention and were randomized to exenatide extended release 2 mg (n = 22) or placebo (n = 22) subcutaneous injections given once weekly.
Show in the study text Report a problemFND-3206286203
08HumanRandomized controlled trialEfficacy outcome
In adolescents with obesity, exenatide reduced waist circumference versus placebo.
In plain wordsIn adolescents with obesity, exenatide reduced waist size more than placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseWaist circumference
Study
n = 44
Comparator
Placebo
Outcome group
Body composition · Metabolic and weight
Studied dose
2 mg once weekly · subcutaneous · 6 monthsAs given in this study (human).
Measurements
Waist circumference difference
−3.2 cm
versus placebo
Source sentences
Summary
waist circumference (-3.2 cm; -5.8, -0.7)
2 context sentences(design, population, supporting numbers)
Summary · context
Six-month, randomized, double-blinded, parallel, placebo-controlled clinical trial in patients (n = 44, 10-18 years, females n = 22) with BMI-SDS > 2.0 or age-adapted-BMI > 30 kg/m² according to WHO were included.
Summary · context
Patients received lifestyle intervention and were randomized to exenatide extended release 2 mg (n = 22) or placebo (n = 22) subcutaneous injections given once weekly.
Show in the study text Report a problemFND-3206286204
09HumanRandomized controlled trialEfficacy outcome
In adolescents with obesity, exenatide reduced subcutaneous adipose tissue versus placebo.
In plain wordsIn adolescents with obesity, exenatide reduced fat beneath the skin more than placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseSubcutaneous adipose tissue
Study
n = 44
Comparator
Placebo
Outcome group
Body composition · Metabolic and weight
Studied dose
2 mg once weekly · subcutaneous · 6 monthsAs given in this study (human).
Measurements
Subcutaneous adipose tissue difference
−552 cm<sup>3</sup>
versus placebo
Source sentences
Summary
subcutaneous adipose tissue (-552 cm³ ; -989, -114)
2 context sentences(design, population, supporting numbers)
Summary · context
Six-month, randomized, double-blinded, parallel, placebo-controlled clinical trial in patients (n = 44, 10-18 years, females n = 22) with BMI-SDS > 2.0 or age-adapted-BMI > 30 kg/m² according to WHO were included.
Summary · context
Patients received lifestyle intervention and were randomized to exenatide extended release 2 mg (n = 22) or placebo (n = 22) subcutaneous injections given once weekly.
Show in the study text Report a problemFND-3206286205
10HumanRandomized controlled trialSafety outcome
In adolescents with obesity, safety and tolerability were comparable between exenatide and placebo, except for mild adverse events.
In plain wordsIn adolescents with obesity, safety and tolerability were similar with exenatide and placebo, except for mild adverse events.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeSafety and tolerability profile
Study
n = 44
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
2 mg once weekly · subcutaneous · 6 monthsAs given in this study (human).
Source sentences
Summary
Safety and tolerability profiles were comparable to placebo with the exception of mild adverse events being more frequent in exenatide-treated patients.
2 context sentences(design, population, supporting numbers)
Summary · context
Six-month, randomized, double-blinded, parallel, placebo-controlled clinical trial in patients (n = 44, 10-18 years, females n = 22) with BMI-SDS > 2.0 or age-adapted-BMI > 30 kg/m² according to WHO were included.
Summary · context
Patients received lifestyle intervention and were randomized to exenatide extended release 2 mg (n = 22) or placebo (n = 22) subcutaneous injections given once weekly.
Show in the study text Report a problemFND-3206286210
11HumanRandomized controlled trialSafety outcome
In adolescents with obesity, mild adverse events were more frequent with exenatide than placebo.
In plain wordsIn adolescents with obesity, exenatide caused more mild adverse events than placebo.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseMild adverse events
Study
n = 44
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
2 mg once weekly · subcutaneous · 6 monthsAs given in this study (human).
Source sentences
Summary
Safety and tolerability profiles were comparable to placebo with the exception of mild adverse events being more frequent in exenatide-treated patients.
2 context sentences(design, population, supporting numbers)
Summary · context
Six-month, randomized, double-blinded, parallel, placebo-controlled clinical trial in patients (n = 44, 10-18 years, females n = 22) with BMI-SDS > 2.0 or age-adapted-BMI > 30 kg/m² according to WHO were included.
Summary · context
Patients received lifestyle intervention and were randomized to exenatide extended release 2 mg (n = 22) or placebo (n = 22) subcutaneous injections given once weekly.
Show in the study text Report a problemFND-3206286211

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Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
22 Oct 2026, 02:26 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

Subjects

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A 6-month randomized, double-blind, placebo-controlled trial of weekly exenatide in adolescents with obesity.

Summary

Results from this study11

Version history

Subjects

Publication types

MeSH terms

Keywords