What this trial means for you
This study is opening soon at 1 US site. It's studying Semaglutide (Wegovy) weekly injection for gestational diabetes mellitus (gdm), metabolic syndrome.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study, ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry. Bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
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
Study sites by state
Massachusetts
- UMass Memorial, Worcester
View the official record on ClinicalTrials.gov →
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