Semaglutide for the Treatment of Glucose Intolerance in Women With Prior Gestational Diabetes

NCT05569772 · Recruiting

Last updated 2026-05-28

This clinical trial is testing whether semaglutide, a medication, can help prevent type 2 diabetes in women who recently had gestational diabetes and now have glucose intolerance.

Status Recruiting Currently enrolling participants.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, triple-blind prevention study

Participants 252 people Planned (estimated).

Who can join Ages 18+ · female only

Timeline Started 2023-09 · est. completion 2029-12

Where 13 sites · Belgium

What this study is testing ClinicalTrials.gov NCT05569772 ↗

Description as written by the study sponsor.

Gestational diabetes (GDM) is an important contributor to the increasing prevalence of type 2 diabetes (T2DM). Women with glucose intolerance in early postpartum are a particularly high-risk group with about 50% who will develop T2DM within 5 years after the delivery. Moreover, women with a history of GDM progress more rapidly to T2DM compared to women with similarly elevated glucose levels. Early intervention after the index pregnancy is therefore crucial to prevent T2DM. With the SERENA project, the investigators aim to reduce the risk to develop T2DM with the long-acting GLP-1 agonist semaglutide in women with a recent history of GDM and glucose intolerance in early postpartum.

Treatments tested

Semaglutide Pen Injector also known as Ozempic Drug

maintenance dose of 1mg SC once weekly
Semaglutide placebo Drug

maintenance dose of 1mg SC once weekly

Main thing measured	type 2 diabetes
Sponsor	Universitaire Ziekenhuizen KU Leuven
Conditions studied	Glucose Intolerance After a Recent History of Gestational Diabetes
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05569772 ↗