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

NCT04873050 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2025-03-13

No results posted yet for this study

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

Interventions

DRUG

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

DRUG

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

Sponsors & Collaborators

Principal Investigators

  • Elizabeth Sutton, PhD · Woman's Hospital, Louisiana

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-13
Primary Completion
2026-01-01
Completion
2026-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04873050 on ClinicalTrials.gov