Clinical trial

Postpartum Semaglutide to Reduce Cardiometabolic Risk After Gestational Diabetes

Opening soon · Phase 2, Phase 3 · 1 countries · Registry ID NCT07797036

Opening soonPhase 2, Phase 3Interventional

What this study is about

This is an effectiveness-implementation Hybrid Type 1 study using a randomized clinical trial design to evaluate the effectiveness and potential real-world integration of immediate postpartum semaglutide following a pregnancy complicated by gestational diabetes mellitus (GDM). A total of 226 postpartum individuals with recent GDM will be randomized 1:1 to semaglutide or standard postpartum care for a 6-month active treatment phase. The primary effectiveness outcome, development of metabolic syndrome, will be assessed at 6 months postpartum. Participants will subsequently enter a 6-month maintenance phase, during which semaglutide continuation, discontinuation, or initiation will reflect patient preferences, clinical decision-making, medication access, and insurance coverage.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexFemale

Healthy volunteersNot accepted

ConditionGestational Diabetes Mellitus (GDM), Metabolic Syndrome

Full registry criteria

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

Treatments and study arms

Semaglutide (Wegovy) weekly injection

Drug

The intervention is semaglutide initiated within 6 weeks of delivery and administered once weekly for 6 months to postpartum individuals following a pregnancy complicated by gestational diabetes mellitus (GDM). Participants randomized to the intervention arm will receive semaglutide in addition to standard postpartum care. Treatment will be initiated using a standardized dose-escalation regimen consistent with the approved prescribing approach to improve tolerability, with dose adjustments or discontinuation based on tolerability and clinical safety.

Primary outcomes

Metabolic Syndrome6 months after randomization

Metabolic syndrome will be treated as a binary variable. Metabolic syndrome is defined as a cluster of cardiovascular risk factors that is defined as having three or more of the following five criteria: waist circumference over 88 centimeters in women, blood pressure greater than or equal to 130/85 mmHg, fasting triglyceride (TG) level greater than or equal to 150 mg/dL, fasting high-density lipoprotein (HDL) cholesterol level less than 50 mg/dl (women) and fasting blood sugar greater than or equal to 110 mg/dL.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

UMass Memorial🇺🇸 Worcester, Massachusetts, United States

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