Gestational Diabetes Mellitus (GDM)Phase 2/3NCT07797036
Postpartum Semaglutide to Reduce Cardiometabolic Risk After Gestational Diabetes Mellitus
A Phase 2/3 study testing Semaglutide (Wegovy) weekly injection in people with Gestational Diabetes Mellitus (GDM) and Metabolic Syndrome, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM), Metabolic Syndrome
- What is being tested?
- Semaglutide (Wegovy) weekly injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2027to 31 Dec 2030
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18
- Postpartum state (delivered within 6 weeks)
- Ability and willingness to provide informed consent
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Postpartum Semaglutide to Reduce Cardiometabolic Risk After Gestational Diabetes: An Effectiveness-Implementation Hybrid Type 1 Randomized Trial
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.
- Being tested
- Semaglutide (Wegovy) weekly injection
- Keywords
- postpartum, gestational diabetes mellitus, metabolic syndrome, GLP-1 receptor agonist, semaglutide
- Medical subject headings
- Diabetes, Gestational, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide (Wegovy) weekly injectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Experimental | 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. Receives: Drug: Semaglutide (Wegovy) weekly injection |
| Standard of Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after randomization
Secondary outcomes (9)
Percent Weight Loss
Calculated from measured weight at baseline and from initial prenatal visit weight
Measured: 3, 6, and 12 months after randomization
Body Mass Index
Calculated from the height and weight
Measured: Baseline, 3, 6, and 12 months after randomization
Waist Circumference
Standardized anthropometric measurement in centimeters
Measured: 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
Measured: Baseline, 3, 6, and 12 months after randomization
Concentration of Fasting Blood Sugar
Laboratory assay of fasting blood sugar
Measured: Baseline, 3, 6, and 12 months after randomization
Concentration of Triglycerides
Laboratory assay
Measured: Baseline, 3, 6, and 12 months after randomization
Concentration of High Density Lipoprotein (HDL) Cholesterol
Laboratory assay
Measured: Baseline, 3, 6, and 12 months after randomization
Type 2 Diabetes Mellitus
Diagnosed by a hemoglobin A1c greater than 6.4%
Measured: 3, 6, and 12 months after randomization
Concentration of High sensitivity troponin
Laboratory assay assessing cardiac injury
Measured: Baseline, 3, 6, and 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Sep 2027 (estimated)
- Primary completion1 Sep 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus (GDM)Studies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianna Wilkie, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797036
- Sponsor's protocol ID
- STUDY00003387
- Other IDs
- U1111-1346-0976
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will share aggregate summarized level data to protect patient confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Semaglutide to Reduce Cardiometabolic Risk After Gestational Diabetes: An Effectiveness-Implementation Hybrid Type 1 Randomized Trial
- ClinicalTrials.gov ID
- NCT07797036
- Acronym / sponsor ID
- STUDY00003387
- Keywords
- postpartum, gestational diabetes mellitus, metabolic syndrome, GLP-1 receptor agonist, semaglutide
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- 1 Sep 2027 (estimated)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Experimental | Drug: Semaglutide (Wegovy) weekly injectionThe 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. |
| Standard of Care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than or equal to 18
- Postpartum state (delivered within 6 weeks)
- Ability and willingness to provide informed consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide (Wegovy) weekly injectionThe 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. | Drug | Semaglutide |
Primary outcome
Metabolic Syndrome
Time frame: 6 months after randomization
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.
9 secondary outcomes
Percent Weight Loss
Time frame: 3, 6, and 12 months after randomization
Body Mass Index
Time frame: Baseline, 3, 6, and 12 months after randomization
Waist Circumference
Time frame: Baseline, 3, 6, and 12 months after randomization
Systolic and Diastolic Blood Pressure
Time frame: Baseline, 3, 6, and 12 months after randomization
Concentration of Fasting Blood Sugar
Time frame: Baseline, 3, 6, and 12 months after randomization
Concentration of Triglycerides
Time frame: Baseline, 3, 6, and 12 months after randomization
Concentration of High Density Lipoprotein (HDL) Cholesterol
Time frame: Baseline, 3, 6, and 12 months after randomization
Type 2 Diabetes Mellitus
Time frame: 3, 6, and 12 months after randomization
Concentration of High sensitivity troponin
Time frame: Baseline, 3, 6, and 12 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No. The investigators will share aggregate summarized level data to protect patient confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Semaglutide (Wegovy) weekly injection in people with Gestational Diabetes Mellitus (GDM) and Metabolic Syndrome, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gianna L Wilkie, MD, MSc (508-334-0550, Gianna.Wilkie@umassmemorial.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic Syndrome (time frame: 6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.