Postpartum Semaglutide to Reduce Cardiometabolic Risk After Gestational Diabetes Mellitus

NCT07797036 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: STUDY00003387U1111-1346-0976
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Syndrome; Gestational Diabetes Mellitus (GDM)

Keywords

postpartum; gestational diabetes mellitus; metabolic syndrome; GLP-1 receptor agonist; semaglutide

Outcome Measures

Primary Outcomes (1)

• Metabolic Syndrome

  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 and fasting blood sugar greater than or equal to 110 mg/dL.

  6 months after randomization

Secondary Outcomes (9)

• Percent Weight Loss

  3, 6, and 12 months after randomization

• Body Mass Index

  Baseline, 3, 6, and 12 months after randomization

• Waist Circumference

  Baseline, 3, 6, and 12 months after randomization

• Systolic and Diastolic Blood Pressure

  Baseline, 3, 6, and 12 months after randomization

• Concentration of Fasting Blood Sugar

  Baseline, 3, 6, and 12 months after randomization

Study Arms (2)

Semaglutide

EXPERIMENTAL

The intervention/active arm 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.

Drug: Semaglutide (Wegovy) weekly injection

Standard of Care

NO INTERVENTION

Participants randomized to the control arm will receive standard postpartum care following a pregnancy complicated by gestational diabetes mellitus (GDM). Standard care will include educational materials addressing postpartum diabetes screening, healthy nutrition, physical activity, weight management, and long-term cardiometabolic risk following GDM. Participants will otherwise receive routine clinical care according to their treating providers and will not receive study-provided semaglutide during the 6-month randomized active phase.

Interventions

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.

Semaglutide

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 18
• Postpartum state (delivered within 6 weeks)
• Ability and willingness to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

UMass Memorial

Worcester, Massachusetts, 01605, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational; Metabolic Syndrome

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism

Central Study Contacts

Gianna L Wilkie, MD, MSc

CONTACT

508-334-0550; Gianna.Wilkie@umassmemorial.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 1, 2026
• Study Start (Estimated): September 1, 2027
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)