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← All trials/NCT07770152

GLP1

Not yet recruitingPhase 4

Semaglutide in Youth With Autism Spectrum Disorder

Semaglutide for Metabolic and Adiposity-Related Targets in Youth With Autism Spectrum Disorder (SMART-ASD)

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

-

Estimated enrollment

42

Study population

Autism Spectrum Disorder, Obesity / overweight

Eligibility highlights

-

Primary endpoints

•BMI (kg/m2)•Skeletal Muscle Mass (SMM)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07770152
Org study ID2026-0494

Timeline

Milestones

Study first posted2026-08-18actual
Last update posted2026-08-18actual
Study start2026-09-01estimated
Primary completion2028-09-01estimated
Study completion2029-09-01estimated

Assets

Investigational agents

Semaglutide

Who this study enrolls

Autism Spectrum DisorderObesity / overweight

Who can enroll

Minimum age12 Years
Maximum age18 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (24)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
6
Weight & body composition
4
Cardiometabolic biomarkers
4
Glycemic / diabetes
3
Other clinical outcomes
3
MASH / liver
2
Other (unclassified)
2

Weight & body composition

4 endpoints
Primary/protocol endpoint

Number of Participants With Percent Change in BMI (kg/m2)

Time frame:12 months

percent change from baseline, improvement

Secondary/protocol endpoint

Number of Participants with Change in Body Weight

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint

Number of Participants with Change in BMI z-Score

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint

Number of Participants with Change in Fat Mass

Time frame:12 months

change from baseline, improvement

Glycemic / diabetes

3 endpoints
Secondary/protocol endpoint

Number of Participants with Change in Hemoglobin A1c

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint

Number of Participants with Change in Fasting Insulin

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint

Number of Participants with Change in Fasting Glucose

Time frame:12 months

change from baseline, improvement

MASH / liver

2 endpoints
Secondary/protocol endpoint

Number of Participants with Change in Alanine Aminotransferase (ALT)

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint

Number of Participants with Change in Aspartate Aminotransferase (AST)

Time frame:12 months

change from baseline, improvement

Cardiometabolic biomarkers

4 endpoints
Secondary/protocol endpoint

Number of Participants with Change in Total Cholesterol

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint

Number of Participants with Change in LDL Cholesterol

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint

Number of Participants with Change in HDL Cholesterol

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint

Number of Participants with Change in Triglycerides

Time frame:12 months

change from baseline, improvement

Safety / tolerability / PK

6 endpoints
Primary/protocol endpoint

Number of Participants With Change in Skeletal Muscle Mass (SMM)

Time frame:12 months

change from baseline, event

Secondary/protocol endpoint

Number of Participants with Change in Percent Body Fat

Time frame:12 months

change from baseline, event

Secondary/protocol endpoint

Number of Participants with Change in Fat-Free Mass

Time frame:12 months

change from baseline, event

Secondary/protocol endpoint

Number of Participants with Change in Gamma-Glutamyl Transferase (GGT)

Time frame:12 months

change from baseline, event

Other/protocol endpoint

Rate of Gastrointestinal Adverse Effects

Time frame:12 months

descriptive

Other/protocol endpoint

Rate of Semaglutide Tolerability

Time frame:12 months

descriptive

Other clinical outcomes

3 endpoints
Other/protocol endpoint

Rate of Medication Adherence

Time frame:12 months

descriptive

Other/protocol endpoint

Number of Participants who Achieve Target Dose

Time frame:12 months

threshold achievement, improvement

Other/protocol endpoint

Rate of Recruitment Feasibility

Time frame:Enrollment period

descriptive

Other (unclassified)

2 endpoints
Other/protocol endpoint/low confidence

Rate of Semaglutide Initiation

Time frame:12 months

descriptive

Other/protocol endpoint/low confidence

Rate of Medication Persistence

Time frame:12 months

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.