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Postpartum Semaglutide to Reduce Cardiometabolic Risk After Gestational Diabetes Mellitus

StatusNot Yet Recruiting
PhasePhase 2/3
Started
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Record History

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  1. Re-verified, no change to tracked fields
  2. Secondary endpoints revised (9)
    • Study title expanded, about 1 word
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07797036
Lead Sponsor University of Massachusetts, Worcester
Conditions
(from sponsor)		 Gestational Diabetes Mellitus (GDM), Metabolic Syndrome
Related terms Diabetes, Gestational, Metabolic Syndrome
Enrollment 226 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov