A Phase 2/3 interventional study of Semaglutide (Wegovy) weekly injection in Gestational Diabetes Mellitus (GDM) and Metabolic Syndrome, sponsored by University of Massachusetts, Worcester. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by University of Massachusetts, Worcester · Phase 2/3, Interventional, and Prevention
Among 251 studies in Diabetes, Gestational with a site in United States — 53 open to participants now, 65 under way, 2 of them phase 3. Diabetes, Gestational · United States.
Among the 251 studies in Diabetes, Gestational with a site in United States, this one is the 40th largest by planned enrollment of the 194 interventional ones that give a count, is the only one that started in 2027, is one of 2 in phase 2/3, reaches primary completion later than 62 of the 64 other live ones, and was the 248th registered.
877 studies on the registry are indexed under Diabetes, Gestational; 203 are open to participants now.
Browse Diabetes, Gestational studies →53 of the 251 studies in Diabetes, Gestational with a site in United States are open now. Recruiting first, the newest first:
Mayo Clinic · Sites in United States
Medical College of Wisconsin · Sites in United States
Texas A&M University · Sites in United States
University of Hawaii · Sites in United States
University of California, Davis · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 139 Diabetes, Gestational studies recruiting now, 63 (45%) set no upper age limit and 74 (53%) stop at 75 or younger; 14 take children under 18; 63 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
251 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 14 · Phase 2 11 · Phase 3 9 · Phase 4 11
First in 2000; this study’s year is marked. 1 started in 2027.
This study's planned enrollment of 226 is above the median of 110 across 564 interventional studies indexed under Diabetes, Gestational.
Median enrollment 80 across the 194 interventional studies, 72 across the 57 observational. Of the 154 that completed or were terminated, 35 (23%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 251 have an industry lead sponsor. The 10 most frequent:
University of Massachusetts, Worcester is the lead sponsor of 291 studies on the registry; 51 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.
University of Massachusetts, Worcester has 3 studies filed under Diabetes, Gestational — fewer than ten, so there is no comparison to draw.
22 of the studies in Diabetes, Gestational with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07356180University of Maryland, BaltimorePhysical Acvitiy in Pregnancy | 2026-12 |
| NCT05909046Ohio State UniversityA Randomized Controlled Trial of Diabetes Screening Immediately Postpartum (DIP) and Follow Up PP CARE | 2026-12 |
| NCT05388643University of Massachusetts, WorcesterEarly Detection of Gestational Diabetes Mellitus in Pregnancy | 2026-12-01 |
| NCT07176793University of California, DavisPregnancy and Postpartum Breastfeeding Support for Patients With Gestational Diabetes | 2026-12-30 |
| NCT05124808Indiana UniversityIntensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes | 2026-12-31 |
Among the 251 studies in Diabetes, Gestational with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Semaglutide (Wegovy) weekly injection
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.
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.
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.
Time frame: 6 months after randomization
Percent Weight Loss
Calculated from measured weight at baseline and from initial prenatal visit weight
Time frame: 3, 6, and 12 months after randomization
Body Mass Index
Calculated from the height and weight
Time frame: Baseline, 3, 6, and 12 months after randomization
Waist Circumference
Standardized anthropometric measurement in centimeters
Time frame: 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
Time frame: Baseline, 3, 6, and 12 months after randomization
Concentration of Fasting Blood Sugar
Laboratory assay of fasting blood sugar
Time frame: Baseline, 3, 6, and 12 months after randomization
Concentration of Triglycerides
Laboratory assay
Time frame: Baseline, 3, 6, and 12 months after randomization
Concentration of High Density Lipoprotein (HDL) Cholesterol
Laboratory assay
Time frame: Baseline, 3, 6, and 12 months after randomization
Type 2 Diabetes Mellitus
Diagnosed by a hemoglobin A1c greater than 6.4%
Time frame: 3, 6, and 12 months after randomization
Concentration of High sensitivity troponin
Laboratory assay assessing cardiac injury
Time frame: Baseline, 3, 6, and 12 months after randomization
Plan to share: No — The investigators will share aggregate summarized level data to protect patient confidentiality.
No publications or documents are linked to this record.
Start is estimated for Sep 2027; primary completion for Sep 2030, 36 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Semaglutide
University of Massachusetts, Worcester →