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Not yet recruitingPhase 2 / Phase 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests semaglutide after birth in people who had gestational diabetes (diabetes during pregnancy). It compares the medicine with standard care for 6 months to see if it lowers the risk of metabolic syndrome, a group of health problems linked to heart disease and diabetes. Participants then have 6 more months of follow-up, when medicine use may change.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Gave birth within the past 6 weeks.
  • Able and willing to give informed consent (agree to join after learning about the study).

Who can't join

  • Past pancreatitis (swelling of the pancreas), either sudden or long-lasting.
  • You or a parent, sibling, or child has had multiple endocrine neoplasia type 2 (a disorder that causes tumors in glands) or medullary thyroid cancer.
  • Type 1 or type 2 diabetes diagnosed before pregnancy, or a body mass index (BMI, a measure based on height and weight) below 25.
  • Pregnant now, planning to try to get pregnant within 12 months, or currently breastfeeding or making breast milk.
  • Known allergy from taking semaglutide before, or previous participation in this trial.
  • Thoughts of suicide or a suicide attempt in the past 12 months.
  • An eating disorder diagnosed now or in the past 12 months, including anorexia, bulimia, or binge eating disorder.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 (1)

MA