Postpartum Semaglutide to Reduce Cardiometabolic Risk After Gestational Diabetes Mellitus
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Massachusetts, Worcester
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age greater than or equal to 18
Postpartum state (delivered within 6 weeks)
Ability and willingness to provide informed consent
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Semaglutide (Wegovy) weekly injection
DrugThe 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.
Treatment groups
226 Participants
are divided into 2 treatment groupsGroup A: SemaglutideExperimental treatment 1 intervention
Group B: Standard of CareNo intervention 0 interventions
Trial outcomes
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.
Time frame
6 months after randomizationSecondary outcomes
1
Percent Weight Loss
Calculated from measured weight at baseline and from initial prenatal visit weight
Time frame
3, 6, and 12 months after randomization2
Body Mass Index
Calculated from the height and weight
Time frame
Baseline, 3, 6, and 12 months after randomization3
Waist Circumference
Standardized anthropometric measurement in centimeters
Time frame
Baseline, 3, 6, and 12 months after randomization4
Systolic and Diastolic Blood Pressure
Mean blood pressure from 3 automated measurements taken after resting for 5 minutes
Time frame
Baseline, 3, 6, and 12 months after randomizationSponsors and contacts
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Source ClinicalTrials.gov
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