Recruiting

Normoglycemia

Sponsor:

Woman's

Code:

NCT04873050

Conditions

Pre Diabetes

Postpartum Disorder

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Semaglutide Pen Injector [Ozempic]

Placebo semaglutide pen injector

Study Details

Brief summary:

The purpose of the study is to determine the efficacy of semaglutide 1mg (Ozempic®) to aid recently postpartum women with dysglycemia and a history of GDM to regress to normoglycemia; thereby filling a gap in efficacious pharmacologic intervention options for clinicians to support postpartum diabetes recovery and reduce future risk of T2DM in young women.

Conditions

Pre Diabetes

Postpartum Disorder

Study ID

NCT04873050

Start date

Jan 13, 2022

Status verified date

Mar, 2025

Completion date

Mar 1, 2026

Anticipated

Primary completion date

Jan 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

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

Study Design

Enrollment

102 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Semaglutide Pen Injector (Ozempic)

Weekly injections of semaglutide for 8 months total (2 months of titration; 6 months of full dose- 1mg/week)

sham comparator: Placebo

Weekly injections of placebo for 8 months total

Interventions

Semaglutide Pen Injector [Ozempic]

Start injection of semaglutide 0.25mg subcutaneously (SC) once a week for 4 weeks; step up to 0.5 mg SC QD for once a week for 4 weeks to a final dose of 1.0 mg semaglutide SQ weekly for 24 doses

Placebo semaglutide pen injector

Start injection of placebo semaglutide 0.25mg subcutaneously (SC) one a week for 4 weeks; step up to 0.5 mg SC QD for once a week for 4 weeks to a final dose of 1.0 mg semaglutide SQ weekly for 24 doses

Primary outcome measure

  • Regression to normoglycemia [ Time Frame: After 24 weeks of full-dose treatment ]

Central Contacts and Locations

Central contacts

Locations

Woman's Hospital

Recruiting

Baton Rouge, Louisiana, United States, 70817

Contacts

More Information

Sponsor

Woman's

Last update posted

Mar 13, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Woman's on 2025-03-13.