Not yet recruitingPhase 2, PHASE3

Postpartum Semaglutide to Reduce Cardiometabolic Risk After Gestational Diabetes Mellitus

Postpartum Semaglutide to Reduce Cardiometabolic Risk After Gestational Diabetes: An Effectiveness-Implementation Hybrid Type 1 Randomized Trial

Lead sponsor

University of Massachusetts, Worcester

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

226

Study population

Gestational diabetes, Metabolic syndrome

Eligibility highlights

•Female

Primary endpoint

•Metabolic Syndrome

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 IDNCT07797036

Org study IDSTUDY00003387

Secondary IDU1111-1346-0976WHO/UTN

Timeline

Milestones

Study first posted2026-09-01actual

Last update posted2026-09-28actual

Study start2027-09-01estimated

Primary completion2030-09-01estimated

Study completion2030-12-31estimated

Assets

Investigational agents

Semaglutide

Who this study enrolls

Gestational diabetesMetabolic syndrome

Who can enroll

Minimum age18 Years

SexFemale

Healthy volunteersNot accepted

Inclusion criteria

•Age greater than or equal to 18

•Postpartum state (delivered within 6 weeks)

•Ability and willingness to provide informed consent

Exclusion criteria

•a history of acute or chronic pancreatitis

•personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma

•diagnosis of pre-gestational diabetes (type 1 or 2 diabetes mellitus)

•body mass index <25 kg/m2

•Plan to attempt pregnancy within next 12 months or confirmed pregnancy

•Known allergy to semaglutide from prior exposure

•Previous participation in this trial

•History of suicidal ideation/attempt in the past 12 months

•Current or recent diagnosis in the last 12 months of anorexia nervosa, bulimia nervosa, binge eating disorder, or other eating disorder

•Actively breastfeeding or lactating

Endpoints (10)

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

Weight & body composition

Cardiometabolic biomarkers

Other (unclassified)

Glycemic / diabetes

Weight & body composition

3 endpoints

Secondary/protocol endpoint

Percent Weight Loss

Time frame:3, 6, and 12 months after randomization

descriptive

Secondary/protocol endpoint

Body Mass Index

Time frame:Baseline, 3, 6, and 12 months after randomization

descriptive

Secondary/protocol endpoint

Waist Circumference

Time frame:Baseline, 3, 6, and 12 months after randomization

descriptive

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

Type 2 Diabetes Mellitus

Time frame:3, 6, and 12 months after randomization

descriptive

Cardiometabolic biomarkers

3 endpoints

Secondary/protocol endpoint

Systolic and Diastolic Blood Pressure

Time frame:Baseline, 3, 6, and 12 months after randomization

descriptive

Secondary/protocol endpoint

Concentration of Triglycerides

Time frame:Baseline, 3, 6, and 12 months after randomization

concentration, descriptive

Secondary/protocol endpoint

Concentration of High Density Lipoprotein (HDL) Cholesterol

Time frame:Baseline, 3, 6, and 12 months after randomization

concentration, descriptive

Other (unclassified)

3 endpoints

Primary/protocol endpoint/low confidence

Metabolic Syndrome

Time frame:6 months after randomization

descriptive

Secondary/protocol endpoint/low confidence

Concentration of Fasting Blood Sugar

Time frame:Baseline, 3, 6, and 12 months after randomization

concentration, descriptive

Secondary/protocol endpoint/low confidence

Concentration of High sensitivity troponin

Time frame:Baseline, 3, 6, and 12 months after randomization

concentration, 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.