NCT07797036Not yet recruitingPhase 2/3
Postpartum Semaglutide to Reduce Cardiometabolic Risk After Gestational Diabetes Mellitus
Postpartum Semaglutide to Reduce Cardiometabolic Risk After Gestational Diabetes: An Effectiveness-Implementation Hybrid Type 1 Randomized Trial
Source: ClinicalTrials.gov · Last updated 28 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 226 (estimated)
- First submitted
- 27 Aug 2026
- Start date
- 1 Sept 2027
- Primary completion date
- 1 Sept 2030
- Lead sponsor
- University of Massachusetts, Worcester
- Diseases
- Type 1 diabetes
- NCT number
- NCT07797036
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 226
- From 1 Sept 2027 to the primary completion date, 1 Sept 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known allergy to semaglutide from prior exposure
- Previous participation in this trial
Other illness
- 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)
- 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
Other
- body mass index \<25 kg/m2
- Plan to attempt pregnancy within next 12 months or confirmed pregnancy
- Actively breastfeeding or lactating
Who the study is looking for
- Age greater than or equal to 18
- Postpartum state (delivered within 6 weeks)
- Ability and willingness to provide informed consent
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UMass Memorial Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.