Gestational Diabetes Mellitus (GDM)Phase 2/3NCT07797036
Postpartum Semaglutide to Reduce Cardiometabolic Risk After Gestational Diabetes Mellitus
A Phase 2/3 study testing Semaglutide (Wegovy) weekly injection in people with Gestational Diabetes Mellitus (GDM) and Metabolic Syndrome, run by University of Massachusetts, Worcester at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM), Metabolic Syndrome
- What is being tested?
- Semaglutide (Wegovy) weekly injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2027to 31 Dec 2030
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18
- Postpartum state (delivered within 6 weeks)
- Ability and willingness to provide informed consent
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Postpartum Semaglutide to Reduce Cardiometabolic Risk After Gestational Diabetes: An Effectiveness-Implementation Hybrid Type 1 Randomized 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.
- Being tested
- Semaglutide (Wegovy) weekly injection
- Keywords
- postpartum, gestational diabetes mellitus, metabolic syndrome, GLP-1 receptor agonist, semaglutide
- Medical subject headings
- Diabetes, Gestational, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide (Wegovy) weekly injectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after randomization
Secondary outcomes (9)
Percent Weight Loss
Calculated from measured weight at baseline and from initial prenatal visit weight
Measured: 3, 6, and 12 months after randomization
Body Mass Index
Calculated from the height and weight
Measured: Baseline, 3, 6, and 12 months after randomization
Waist Circumference
Standardized anthropometric measurement in centimeters
Measured: Baseline, 3, 6, and 12 months after randomization
Systolic and Diastolic Blood Pressure
Mean blood pressure from 3 automated measurements taken after resting for 5 minutes
Measured: Baseline, 3, 6, and 12 months after randomization
Concentration of Fasting Blood Sugar
Laboratory assay of fasting blood sugar
Measured: Baseline, 3, 6, and 12 months after randomization
Concentration of Triglycerides
Laboratory assay
Measured: Baseline, 3, 6, and 12 months after randomization
Concentration of High Density Lipoprotein (HDL) Cholesterol
Laboratory assay
Measured: Baseline, 3, 6, and 12 months after randomization
Type 2 Diabetes Mellitus
Diagnosed by a hemoglobin A1c greater than 6.4%
Measured: 3, 6, and 12 months after randomization
Concentration of High sensitivity troponin
Laboratory assay assessing cardiac injury
Measured: Baseline, 3, 6, and 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Sep 2027 (estimated)
- Primary completion1 Sep 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus (GDM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianna Wilkie, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797036
- Sponsor's protocol ID
- STUDY00003387
- Other IDs
- U1111-1346-0976
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will share aggregate summarized level data to protect patient confidentiality.