Severe ObesityPhase 2NCT02496611
Enhancing Weight Loss Maintenance With GLP-1RA (BYDUREON™) in Adolescents With Severe Obesity
A Phase 2 study testing Weight loss with pharmacotherapy and Weight loss without pharmacotherapy in people with Severe Obesity, run by University of Minnesota at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Severe Obesity
- What is being tested?
- Weight loss with pharmacotherapy and Weight loss without pharmacotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 14 Aug 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- BMI ≥1.2 times the 95th percentile (based on sex and age) or BMI ≥35 kg/m2
- 12-17 years old
Who cannot join
- 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
Show all 27Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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 treatment to target weight regain following short-term meal replacement therapy in youth with severe obesity. Participants who achieve ≥5% BMI reduction during the meal replacement phase will be randomized to GLP-1RA treatment or placebo for an additional 52 weeks while simultaneously engaging in lifestyle modification therapy. Importantly, this study will also allow us to examine the extent to which GLP-1RA treatment addresses mechanisms of weight regain, investigate other pleiotropic benefits of GLP-1RA, and identify predictors of weight loss response.
Read the detailed description
Primary Objective Evaluate the effect of GLP-1RA treatment on the maintenance of weight loss and durability of cardiometabolic risk factor improvements among adolescents with severe obesity following a meal replacement induction period. The investigators hypothesize that adolescents with severe obesity receiving GLP-1RA treatment following a short-term meal replacement induction period will demonstrate superior maintenance of initial BMI reduction 52 weeks following randomization compared to those assigned to placebo (primary endpoint) and that a higher proportion of those assigned to GLP-1RA treatment vs. placebo will maintain ≥5% BMI reduction from baseline to the 52-week time point (secondary endpoint).
- Conditions
- Severe Obesity
- Being tested
- Weight loss with pharmacotherapy, Weight loss without pharmacotherapy
- Keywords
- Obesity, Pharmacotherapy, GLP-1, Children, Exenatide, BYDUREON, Weight Loss, Maintenance
- Medical subject headings
- Obesity, Morbid, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight loss with pharmacotherapyDrug
Also called Exenatide extended release
Participants randomized to the drug intervention group will receive Exenatide extended-release.
Weight loss without pharmacotherapyDrug
Also called Placebo
Participants randomized to the placebo group will receive a placebo.
| Study group | Role | What they receive |
|---|---|---|
| Weight Loss Maintenance without Pharmacotherapy | Placebo comparator | 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. Receives: Drug: Weight loss without pharmacotherapy |
| Weight Loss Maintenance with Pharmacotherapy | Active comparator | 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. Receives: Drug: Weight loss with pharmacotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
Percentage of body mass index change from Randomization to Week 52
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startDec 2015
- Primary completion14 Aug 2020
- Study completion14 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Severe ObesityStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individuals who consented to the project were enrolled in a screening phase of the study where they received meal replacement therapy in attempt to achieve a \>/= 5% body mass reduction. Individuals who did not meet this goal were considered screen failures. Individuals who met this goal were allowed to remain in the study and be randomized to one of the treatment arms (placebo or GLP-1 RA). A total of 100 participants consented and were enrolled and 66 participants achieved the required BMI reduction with MRT and were randomized to study treatment (33 to GLP-1 RA (exenatide) and 33 to placebo).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496611
- Sponsor's protocol ID
- 1505M72081
- Status last verified
- Dec 2021
- First submitted
- 6 Jul 2015
- Last updated
- 3 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 42281167Saunders 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.
PubMed 35537665Fox 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.
PubMed 35403350Ryder 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.
PubMed 27496270
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Weight Loss Maintenance With GLP-1RA (BYDUREON™) in Adolescents With Severe Obesity
- ClinicalTrials.gov ID
- NCT02496611
- Acronym / sponsor ID
- 1505M72081
- Conditions
- Severe Obesity
- Keywords
- Obesity, Pharmacotherapy, GLP-1, Children, Exenatide, BYDUREON, Weight Loss, Maintenance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- 14 Aug 2020 (actual)
- Study completion
- 14 Aug 2020 (actual)
- First posted
- 14 Jul 2015 (estimated)
- Results
- Posted 3 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 treatment to target weight regain following short-term meal replacement therapy in youth with severe obesity. Participants who achieve ≥5% BMI reduction during the meal replacement phase will be randomized to GLP-1RA treatment or placebo for an additional 52 weeks while simultaneously engaging in lifestyle modification therapy. Importantly, this study will also allow us to examine the extent to which GLP-1RA treatment addresses mechanisms of weight regain, investigate other pleiotropic benefits of GLP-1RA, and identify predictors of weight loss response.
Detailed description
Primary Objective Evaluate the effect of GLP-1RA treatment on the maintenance of weight loss and durability of cardiometabolic risk factor improvements among adolescents with severe obesity following a meal replacement induction period. The investigators hypothesize that adolescents with severe obesity receiving GLP-1RA treatment following a short-term meal replacement induction period will demonstrate superior maintenance of initial BMI reduction 52 weeks following randomization compared to those assigned to placebo (primary endpoint) and that a higher proportion of those assigned to GLP-1RA treatment vs. placebo will maintain ≥5% BMI reduction from baseline to the 52-week time point (secondary endpoint).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Individuals who consented to the project were enrolled in a screening phase of the study where they received meal replacement therapy in attempt to achieve a >/= 5% body mass reduction. Individuals who did not meet this goal were considered screen failures. Individuals who met this goal were allowed to remain in the study and be randomized to one of the treatment arms (placebo or GLP-1 RA). A total of 100 participants consented and were enrolled and 66 participants achieved the required BMI reduction with MRT and were randomized to study treatment (33 to GLP-1 RA (exenatide) and 33 to placebo).
| Arm | Type | Receives |
|---|---|---|
| Weight Loss Maintenance without Pharmacotherapy | Placebo comparator | Drug: Weight loss without pharmacotherapyIndividuals 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 | Active comparator | Drug: Weight loss with pharmacotherapyIndividuals 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 may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- BMI ≥1.2 times the 95th percentile (based on sex and age) or BMI ≥35 kg/m2
- 12-17 years old
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight loss with pharmacotherapyAlso: Exenatide extended releaseParticipants randomized to the drug intervention group will receive Exenatide extended-release. | Drug | Weight Loss Maintenance with Pharmacotherapy |
| Weight loss without pharmacotherapyAlso: PlaceboParticipants randomized to the placebo group will receive a placebo. | Drug | Weight Loss Maintenance without Pharmacotherapy |
Primary outcome
Body Mass Index
Time frame: 52 weeks
Percentage of body mass index change from Randomization to Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42281167Rode 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.
- Derived from this study: PubMed 35537665Saunders 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.
- Derived from this study: PubMed 35403350Fox 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.
- Derived from this study: PubMed 27496270Ryder 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Weight loss with pharmacotherapy and Weight loss without pharmacotherapy in people with Severe Obesity, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02496611, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2022.