Primary outcome
What NCT02496611 measured first
| Weight Loss Maintenance Without Pharmacotherapyn=33 | Weight Loss Maintenance With Pharmacotherapyn=33 |
|---|---|
| 10.1(9.0) | 4.6(10.5) |
Phase 2 · Exenatide
NCT02496611 trial results
Enhancing Weight Loss Maintenance With GLP-1RA (BYDUREON™) in Adolescents With Severe Obesity
Body Mass Index (percentage (body mass index)), 52 weeks. Weight Loss Maintenance Without Pharmacotherapy: 10.1; Weight Loss Maintenance With Pharmacotherapy: 4.6.
- Participants
- 100
- Status
- completed
- Completed
- 2020-08-14
- Sponsor
- University of Minnesota
As posted on ClinicalTrials.gov (NCT02496611), updated at source Jan 3, 2022. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Side effects by arm
Side effects in NCT02496611
Percent of participants affected, Adverse event and serious adverse event data was collected from Baseline to Week 52.. The most common events the registry lists.
| Event | Weight Loss Maintenance Without Pharmacotherapy | Weight Loss Maintenance With Pharmacotherapy | Meal Replacement Induction |
|---|---|---|---|
| Any serious event | 0% | 3% | 0% |
| Injection Site Reaction | 72.7% | 78.8% | not reported |
| Headache | 42.4% | 57.6% | not reported |
| Nausea | 21.2% | 39.4% | not reported |
| Vomiting | 6.1% | 39.4% | not reported |
| Upper respiratory infection | 39.4% | 21.2% | not reported |
| Diarrhea | 18.2% | 33.3% | not reported |
| Constipation | 18.2% | 18.2% | not reported |
| Dyspepsia | 12.1% | 15.2% | not reported |
| Dizziness | 9.1% | 12.1% | not reported |
| Flu-like symptoms | 12.1% | 9.1% | not reported |
| Abdominal pain | 9.1% | 9.1% | not reported |
The trial
How NCT02496611 was run
Long-term weight loss maintenance is seldom achieved by individuals with obesity owing to numerous biological adaptations involving appetite, satiety, and energy expenditure in the post- weight loss setting. Following a loss in body weight, peripheral and central mechanisms convey a sense that energy reserves have dwindled, activating a strong counter response to increase caloric intake. Adolescents with severe obesity are not immune to the vexing issue of weight regain. Indeed, only 2% are able to achieve and maintain clinically-meaningful weight loss with lifestyle modification therapy. Therefore, novel treatment paradigms focused on long-term weight loss maintenance are urgently needed. Pharmacotherapy has the potential to prevent weight regain by targeting specific counter-regulatory mechanisms in the post- weight loss setting. One of the most promising candidates is the glucagon like peptide-1 receptor agonist (GLP-1RA) class, which greatly enhanced weight loss maintenance following a short-term low calorie diet among adults with obesity. The rationale for focusing on GLP-1RA treatment (BYDUREON™) to prevent weight regain is supported by the multiple central and peripheral mechanisms of action targeted by this class of drug; many of which specifically address the biological adaptations known to induce relapse. The investigators have strong preliminary data demonstrating that GLP-1RA treatment reduces BMI in adolescents with severe obesity. Moreover, the investigators and others have shown that although meal replacement therapy (structured meals of known caloric content) can elicit robust short-term weight loss among adolescents with severe obesity, weight regain is a pervasive problem. Therefore, in this clinical trial, our innovative approach will utilize GLP-1RA...
- Weight Loss Maintenance without Pharmacotherapy: Individuals who, after a short-term (1-3 month) meal replacement induction period, achieve ≥5% BMI reduction. A selection of these participants are then randomized to receive treatment with placebo.
- Weight Loss Maintenance with Pharmacotherapy: Individuals who, after a short-term (1-3 month) meal replacement induction period, achieve a \>/= 5% BMI reduction. A selection of these participants are then randomized to receive treatment with GLP-1RA.
Who could join the trial
Inclusion Criteria: * BMI ≥1.2 times the 95th percentile (based on sex and age) or BMI ≥35 kg/m2 * 12-17 years old Exclusion Criteria: * Type 1 or 2 diabetes mellitus * Previous (within 6 months) or current use of medication(s) prescribed primarily for weight loss (refer to appendix material for comprehensive list) * If currently using weight altering drug(s) for non-obesity indication(s) (refer to appendix material for comprehensive list), any change in drug(s) or dose within the previous 6 months * Previous bariatric surgery * If currently using anti-hypertensive medication(s), lipid medication(s), and/or medication(s) to treat insulin resistance (refer to appendix material for comprehensive list), any change in drug(s) or dose within the previous 6 months * If currently using CPAP/BIPAP (for sleep apnea), change in frequency of use or settings within the previous 6 months * History of treatment with growth hormone * Neurodevelopmental disorder severe enough to impair ability to comply with study protocol * Clinical diagnosis of bipolar illness, schizophrenia, conduct disorder, and/or substance use/abuse * Females: currently pregnant, planning to become pregnant, or unwilling to use 2 or more acceptable methods of contraception when engaging in sexual activity throughout the study * Tobacco use * Liver/renal dysfunction * ALT or AST \>2 times the upper limit of normal * Bicarbonate \<18 mmol/L * Creatinine \>1.2 mg/dL * History of pancreatitis * Personal- and/or family history of medullary thyroid carcinoma * Personal- and/or family history of multiple endocrine neoplasia type 2 * Calcitonin level \>50 ng/L * Bulimia nervosa * Neurological disorder * Hypothalamic obesity * Obesity associated with genetic disorder (monogenetic obesity) * Hyperthyroidism or uncontrolled hypothyroidism * History of suicide attempt * History of suicidal ideation or self-harm within the past year * History of cholelithiasis
Published papers
Papers from NCT02496611
- Rode JB, Wolf JM, Bolan PJ, Palzer E, Rudser KD, Aboobacker S, Fox CK, Kelly AS, Ryder JR. Meal Replacement Therapy for Metabolic Dysfunction-Associated Steatotic Liver Disease in Adolescents with Severe Obesity. Child Obes. 2026 Sep;22(6):389-398. doi: 10.1177/21532176261457202. Epub 2026 Jun 11.
- Saunders SL, Clark JM, Rudser K, Chauhan A, Ryder JR, Bolan PJ. Comparison of automatic liver volumetry performance using different types of magnetic resonance images. Magn Reson Imaging. 2022 Sep;91:16-23. doi: 10.1016/j.mri.2022.05.002. Epub 2022 May 7.
- Fox CK, Clark JM, Rudser KD, Ryder JR, Gross AC, Nathan BM, Sunni M, Dengel DR, Billington CJ, Bensignor MO, Kelly AS. Exenatide for weight-loss maintenance in adolescents with severe obesity: A randomized, placebo-controlled trial. Obesity (Silver Spring). 2022 May;30(5):1105-1115. doi: 10.1002/oby.23395. Epub 2022 Apr 10.
- Ryder JR, Kaizer AM, Rudser KD, Daniels SR, Kelly AS. Utility of Body Mass Index in Identifying Excess Adiposity in Youth Across the Obesity Spectrum. J Pediatr. 2016 Oct;177:255-261.e2. doi: 10.1016/j.jpeds.2016.06.059. Epub 2016 Aug 2.
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
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