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

NCT04873050 · Recruiting

Last updated 2026-05-28

This clinical trial is testing a treatment in women who recently had gestational diabetes to see if it helps their blood sugar levels return to normal.

Status Recruiting Currently enrolling participants.

Phase Phase 4 Monitors a drug already on the market.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 102 people Planned (estimated).

Who can join Ages 18–45 · female only Healthy volunteers accepted.

Timeline Started 2022-01 · est. completion 2026-03

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT04873050 ↗

Description as written by the study sponsor.

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.

Treatments tested

Semaglutide Pen Injector [Ozempic] also known as Semaglutide 1mg, 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
Placebo semaglutide pen injector also known as Placebo Semaglutide 1mg, Placebo Ozempic Drug

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

Main thing measured	Regression to normoglycemia
Sponsor	Woman's
Conditions studied	Pre Diabetes, Postpartum Disorder
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT04873050 ↗