NCT04873050

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2022

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 5, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

January 13, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

4 years

First QC Date

April 29, 2021

Last Update Submit

March 10, 2025

Conditions

Pre DiabetesPostpartum Disorder

Outcome Measures

Primary Outcomes (1)

  • Regression to normoglycemia

    Glucose tolerance to be determined by glycemic response to a 75 gram, two-hour oral glucose tolerance test (OGTT). Regression to normoglycemia is defined by fasting glucose \<100mg/dL and 120 minute glucose \<140 mg/dL

    After 24 weeks of full-dose treatment

Secondary Outcomes (2)

  • Change in HbA1c

    After 24 weeks of full-dose treatment

  • Change in body weight

    After 24 weeks of full-dose treatment

Study Arms (2)

Semaglutide Pen Injector (Ozempic)

EXPERIMENTAL

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

Drug: Semaglutide Pen Injector [Ozempic]

Placebo

SHAM COMPARATOR

Weekly injections of placebo for 8 months total

Drug: Placebo semaglutide pen injector

Interventions

Semaglutide Pen Injector [Ozempic]DRUG

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

Also known as: Semaglutide 1mg, Ozempic
Semaglutide Pen Injector (Ozempic)
Placebo semaglutide pen injectorDRUG

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

Also known as: Placebo Semaglutide 1mg, Placebo Ozempic
Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female
  • years old (inclusive)
  • History of gestational diabetes in most recent pregnancy
  • months - 10 years postpartum
  • BMI ≥ 25 kg/m2
  • Use of long-acting reversible contraception or bilateral tubal ligation
  • Dysglycemia as determined by glycemic response to 75g, 2-hour OGTT: either impaired fasting glucose (IFG), impaired glucose tolerance (IGT), or both (IFG/IGT):
  • Fasting glucose 100-125mg/dL (inclusive) and/or
  • minute glucose 140-199mg/dL (inclusive)
  • Willingness to maintain physical activity level throughout study duration
  • Willingness to standardize diet for 3 days prior to OGTT
  • Ability to provide informed consent before any trial-related activities

You may not qualify if:

  • Body weight \> 350lb
  • Pregnant or the intention of becoming pregnant or not using adequate contraceptive measures.
  • Breastfeeding within 3 months of screening visit 1
  • Post-menopausal
  • Desiring pregnancy within study participation period or two months after participation ends (i.e. 10 months from enrolment)
  • Use of tobacco products within past 6 months
  • Substance or alcohol abuse
  • 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)
  • 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
  • History of bariatric surgery
  • 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
  • Use of medications for anti-obesity or weight loss within four weeks of screening visit 1
  • Use of medications known to exacerbate glucose dysfunction (such as isotretinoin or corticosteroids) within four weeks of screening visit 1
  • Known or suspected allergy to trial medication, excipients, or related products
  • 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)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Woman's Hospital

Baton Rouge, Louisiana, 70817, United States

RECRUITING

MeSH Terms

Conditions

Glucose IntolerancePuerperal Disorders

Interventions

semaglutide

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Elizabeth Sutton, PhD

    Woman's Hospital, Louisiana

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Briasha Jones, MPH

CONTACT

225-924-8446briasha.jones@womans.org

Elizabeth Sutton, PhD

CONTACT

225-924-8446elizabeth.sutton@womans.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Scientific Research

Study Record Dates

First Submitted

April 29, 2021

First Posted

May 5, 2021

Study Start

January 13, 2022

Primary Completion

January 1, 2026

Study Completion

March 1, 2026

Last Updated

March 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)