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Can a diabetes drug curb obesity in teens with autism?

NCT ID NCT07770152

Disease control Sponsor: Children's Hospital Medical Center, Cincinnati Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This trial investigates whether semaglutide, a medication used for diabetes and obesity, can help adolescents aged 12-18 with autism spectrum disorder (ASD) and obesity reduce their body mass index (BMI). Participants will receive either semaglutide injections or lifestyle counseling alone for six months. The study will measure changes in BMI, body composition, and metabolic health, while also monitoring safety and side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Semaglutide, a glucagon-like peptide-1 receptor agonist, given as a weekly injection, plus lifestyle management counseling.
What this could lead to
If successful, this could offer a safe and effective weight-management option for adolescents with autism and obesity, potentially improving their metabolic health and quality of life.
What could go wrong
This is a small, early-phase trial, so results may not apply to everyone. Semaglutide can cause side effects like nausea and vomiting, and its long-term effects in this population are unknown.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 42 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

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

12 to 18 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria (Semaglutide Group): * 12-18 years of age * Epic-confirmed diagnosis of ASD * Obesity defined as BMI ≥95th percentile for age and sex * Have Medicaid or other insurance that will cover semaglutide or the parent is willing to pay for semaglutide out of pocket * Have a parent who is willing to provide informed consent * Can attend in-person, e-visits, or telehealth visits for 12 months * English speaking Exclusion Criteria (Semaglutide Group): * Healthworks patient who has lost \>5% body weight over the past 3 months * Are on a weight loss-promoting medication such as Metformin or Topamax with a dose change in the past 3 months * Have Type 1 or Type 2 diabetes * Have a personal or first-degree family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia 2 * Have been on GLP-1 RAs in the past 12 months * Have significant GI conditions (e.g., pancreatitis), * Are pregnant or breastfeeding * Have catatonia or a condition that may affect compliance and safety Inclusion Criteria (Historical Control Group): * Healthworks patients treated between January 1, 2021-December 31, 2025 * 12-18 years of age * Confirmed diagnosis of ASD * Have obesity defined as BMI ≥95th percentile for age and sex * Have BMI and SMM outcomes assessed at M0, M6, or M12 * Age groups 12-14 years old and 15-18 years old and sex matched to youth in the semaglutide group

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder Obesity obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autism spectrum disorder Obesity

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45245, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.