Can a diabetes drug boost weight loss after teen bariatric surgery?
NCT ID NCT06575738
First seen Jun 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times
Summary
This study looks at what happens to the body after bariatric surgery in people aged 12 to 24. It also tests whether adding semaglutide (a weekly injection) can help those who haven't lost enough weight 1 to 2 years after surgery. The goal is to understand why some respond better than others and to define success beyond just weight loss.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- semaglutide
- What this could lead to
- If it works, this could point toward a way to help teens who don't lose enough weight after bariatric surgery, improving long-term health outcomes.
- What could go wrong
- This is a small, early-phase study with only 40 participants. It's testing a combination of surgery and medication, so results may not apply to everyone, and side effects from semaglutide (like nausea or vomiting) are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 to 24 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Observation Phase Inclusion Criteria: * Signed and dated informed consent form * Willingness to comply with all study procedures and availability for the duration of the study * Male or female biological sex, age 12 through 24 years * In the preoperative pathway for vertical sleeve gastrectomy Exclusion Criteria: * Planned Roux-en-Y gastric bypass * Hypothalamic obesity * Type 2 Diabetes * Current use of oral glucocorticoids (i.e. within 10 days of baseline visit) * Current use of insulin Intervention/Treatment Phase Inclusion Criteria: * Signed and dated informed consent form * Status post vertical sleeve gastrectomy * Male or female biological sex, age 12 through 24 years * Meeting minimum nutrition goals * Obesity: age 12-17 years: BMI ≥95th%ile for age/sex \| age 18-24 years: BMI ≥ 30kg/m\^2 * If entering the Intervention phase from the Observational phase: ≤22% BMI loss at 6-24 months postop * If entering the Intervention phase from the existing patient pool: ≤22% BMI loss at 6-24 months postop Exclusion Criteria: * Surgically correctable cause of suboptimal postoperative weight loss * Known hypersensitivity to any component of semaglutide * Personal or family history of medullary thyroid carcinoma * Personal history of multiple endocrine neoplasia type 2 * Hypothalamic Obesity * Type 2 Diabetes * History of pancreatitis * Uncontrolled hypertension * Clinically significant arrhythmia or heart disease that could be exacerbated by increased heart rate * Malignant neoplasm within the last 5 years * Untreated thyroid disorder * Tanner Stage 1 * Baseline alanine transaminase (ALT) or aspartate aminotransferase (AST) ≥ 5x upper limit of normal * Baseline Creatinine \>1.2mg/dL * Active treatment for bulimia nervosa * Active major psychiatric disorder limiting informed consent * Suicidal ideation of type 4 or 5 on Columbia-Suicide Severity Rating Scale (C-SSRS) * Intentional self-harm within the previous 1 month * Severe unmanaged depression, defined by Center for Epidemiological Studies Depression (CESD) score of 26 or greater and by clinical evaluation * Recent change to concomitant medications for hypertension, dyslipidemia, depression or anxiety (\<4 weeks prior to enrollment) * Use of oral glucocorticoids (within 10 days of baseline visit) * Use of metformin (within 3 months of baseline visit) * Use of insulin secretagogues (within 4 half-lives of the medication of baseline visit) * Current use of insulin * Use of anti-obesity medications (within 4 half-lives of the medication of baseline visit) * Current pregnancy * For females of reproductive potential: Plan to become pregnant in the next 8 months * For females of reproductive potential: Not on contraception (i.e. two forms of birth control for example oral birth control pills and condoms) for at least 1 month prior to enrollment and agreement to use these during study participation and for an additional 8 weeks after the final dose of study medication
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Childrens Hospital Colorado
RECRUITINGAurora, Colorado, 80045, United States
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Other studies related to the condition(s) this trial covers.
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- Can a cold cloth on the neck calm Post-Surgery nausea?