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NCT Number: NCT07797036

Postpartum Semaglutide to Reduce Cardiometabolic Risk After Gestational Diabetes

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.

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Key information

Conditions

Gestational Diabetes Mellitus (GDM) Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

UMass Memorial

Worcester, Massachusetts, 01605, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. Metabolic Syndrome

    Time frame: 6 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.

Secondary outcomes

  1. Percent Weight Loss

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

    Calculated from measured weight at baseline and from initial prenatal visit weight

  2. Body Mass Index

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

    Calculated from the height and weight

  3. Waist Circumference

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

    Standardized anthropometric measurement in centimeters

  4. Systolic and Diastolic Blood Pressure

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

    Mean blood pressure from 3 automated measurements taken after resting for 5 minutes

  5. Fasting Blood Sugar

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

    Laboratory assay of fasting blood sugar

  6. Triglycerides

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

    Laboratory assay

  7. HDL Cholesterol

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

    Laboratory assay

  8. Type 2 Diabetes Mellitus

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

    Diagnosed by a hemoglobin A1c greater than 6.4%

  9. High sensitivity troponin

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

    Laboratory assay assessing cardiac injury

Study contacts

Contact information is provided by the study sponsor or research team.

Gianna L Wilkie, MD, MSc

CONTACT

[email protected]

508-334-0550

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Registry information

Official study title

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

Important dates

Study start
2027
Primary completion
2030
Study completion
2030
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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