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SWEET

RecruitingPhase 4

Treatment to Regress to Normoglycemia in Women with a Recent History of GDM

A Randomized, Placebo-controlled, Double Blind Trial of Semaglutide 1mg (Ozempic®) on Regression to Normoglycemia in WomEn with a Recent History of Gestational DiabETes Mellitus: the SWEET Study

Lead sponsor

Woman's

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

102

estimated

Study population

Gestational diabetes, Obesity / overweight, Prediabetes / glucose intolerance

Key I/E criteria

BMI ≥25Female

Primary endpoint

Regression to normoglycemia

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04873050
Org study IDRP-21-010

Timeline

Milestones

Study first posted2021-05-05actual
Study start2022-01-13actual
Last update posted2025-03-13actual
Primary completion2026-01-01estimated
Study completion2026-03-01estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Gestational diabetesObesity / overweightPrediabetes / glucose intolerance

Eligibility

Who can enroll

Minimum age18 Years
Maximum age45 Years
SexFemale
Healthy volunteersAccepted

Inclusion criteria

1. Female

2. 18 - 45 years old (inclusive)

3. History of gestational diabetes in most recent pregnancy

4. 6 months - 10 years postpartum

5. BMI ≥ 25 kg/m2

6. Use of long-acting reversible contraception or bilateral tubal ligation

7. Dysglycemia as determined by glycemic response to 75g, 2-hour OGTT: either impaired fasting glucose (IFG), impaired glucose tolerance (IGT), or both (IFG/IGT):

1. Fasting glucose 100-125mg/dL (inclusive) and/or

2. 120 minute glucose 140-199mg/dL (inclusive)

8. Willingness to maintain physical activity level throughout study duration

9. Willingness to standardize diet for 3 days prior to OGTT

10. Ability to provide informed consent before any trial-related activities

Exclusion criteria

1. Body weight > 350lb

2. Pregnant or the intention of becoming pregnant or not using adequate contraceptive measures.

3. Breastfeeding within 3 months of screening visit 1

4. Post-menopausal

5. Desiring pregnancy within study participation period or two months after participation ends (i.e. 10 months from enrolment)

6. Use of tobacco products within past 6 months

7. Substance or alcohol abuse

8. Presence of significant systemic disease including: diabetes mellitus (type 1 or type 2), cardiac disease (e.g. congestive heart failure), renal impairment (e.g. serum creatinine levels ≥ 1.4 mg/dL or eGFR < 60), hepatic disease (including viral hepatitis, toxic hepatic damage, jaundice of unknown aetiology, or abnormal liver function tests), pancreatitis, uncontrolled thyroid disease (e.g. documented abnormal TSH), adrenal disease (including Cushing's syndrome, congenital adrenal hyperplasia), hyperlipidemia (fasting triglycerides > 399mg%), untreated or poorly controlled hypertension (resting blood pressure >159/94 mmHg)

9. History of or presence of: eating disorder, malignant disease requiring chemotherapy, or debilitating psychiatric disorder such as psychosis or neurological condition that could confound outcome variables

10. History of bariatric surgery

11. Use of medications for glucose regulation: insulin (e.g. Humalog, Novolog, Humulin), pramlintide, metiglinides, metformin, thiazolidinediones, GLP-1 receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors within four weeks of screening visit 1

12. Use of medications for anti-obesity or weight loss within four weeks of screening visit 1

13. Use of medications known to exacerbate glucose dysfunction (such as isotretinoin or corticosteroids) within four weeks of screening visit 1

14. Known or suspected allergy to trial medication, excipients, or related products

15. Contraindications to study medications: patients with a personal or family history of medullary thyroid cancer or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

16. Current or recent past (within 3 months) participation in another experimental drug trial

17. Previous randomization in this trial

18. Receipt of any investigational drug within 6 months prior to this trial

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
2
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in body weight

Time frame:After 24 weeks of full-dose treatment

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Primary/protocol endpoint/low confidence

Regression to normoglycemia

Time frame:After 24 weeks of full-dose treatment

threshold achievement, improvement

Secondary/protocol endpoint

Change in HbA1c

Time frame:After 24 weeks of full-dose treatment

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.