Glucose Intolerance After a Recent History of Gestational DiabetesPhase 3SERENANCT05569772

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

A Phase 3 study testing Semaglutide Pen Injector in people with Glucose Intolerance After a Recent History of Gestational Diabetes, run by Universitaire Ziekenhuizen KU Leuven at 13 sites in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Glucose Intolerance After a Recent History of Gestational Diabetes
What is being tested?: Semaglutide Pen Injector
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 252 participants
Where: 13 sitesBelgium
Study dates: 14 Sep 2023to May 2030
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Eligible participants are women aged ≥18 years, with a history of GDM diagnosed according to the 2013 WHO criteria (at 24-32 weeks gestation or <24 weeks for early GDM). Participants must have prediabetes diagnosed between 6 weeks and 12 months postpartum according to ADA criteria (FPG 5.6-6.9 mmol/L, 2-hour OGTT glucose 7.8-11.0 mmol/L and/or HbA1c 39-46 mmol/mol [5.7-6.4%]).

Additional inclusion criteria include cessation of breastfeeding, no intention to become pregnant within the next year, use of effective contraception and no use of medication affecting glucose metabolism. Written ICF is obtained prior to any study-related procedures.

Exclusion criteria include established diabetes, presence of autoantibodies suggestive of type 1 diabetes, normal glucose tolerance, history of pancreatitis, previous bariatric surgery or planned surgery within two years, unable to understand and speak Dutch, French or English and current pregnant or planning to become pregnant within one year after participating in the study.

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Katrien Benhalima, MD PhD contact

16340614 ext. 32

katrien.benhalima@uzleuven.be

City, postcode or hospital

Sites recruiting now only

13 sites in 1 country

Belgium13 sites, 13 recruiting

AZORG
Aalst
Katrien Wierckx
Recruiting
UZA
Antwerp
Niels Bochanen
Recruiting
ZAS
Antwerp
Ann Verhaegen
Recruiting
AZ St Jan Brugge
Bruges
Sara Vandewalle, MD, 003250 45 23 3, SARA.VANDEWALLE@azsintjan.be
Recruiting
Erasme
Brussels
Maria Lytrivi
Recruiting
UZ Brussel
Brussels
Nancy Van Wilder
Recruiting
Jan Yperman
Ieper
An Nollet, MD, 003257 35 72 70, an.nollet@yperman.net
Recruiting
AZ Groeninge Kortrijk
Kortrijk
Gertjan Vereecke
Recruiting
UZ Leuven
Leuven
Katrien Benhalima
Recruiting
CHU de Liège
Liège
JC Philips
Recruiting
Centre Hospitalier Mouscron
Mouscron
Philippe Oriot
Recruiting
Vitaz
Sint-Niklaas
Peter Coremans
Recruiting
AZ Turnhout
Turnhout
Joke Cuypers, MD, 003214 44 44 32, joke.cuypers@azturnhout.be
Recruiting

Other trials in Belgium

About this study

Official title: Semaglutide for the Treatment of Glucose Intolerance in Women With Prior Gestational Diabetes: a Double Blind RCT

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.

Read the detailed description

Patient population: Women with a recent history of gestational diabetes (GDM) and persistent glucose intolerance in early postpartum are a particularly high risk group, with about 50% developing type 2 diabetes (T2DM) within 5 years after the delivery. Semaglutide is a long-acting glucagon-like peptide-1 (GLP-1) agonist with multiple beneficial metabolic effects, including glucose lowering effect, weight loss and cardiovascular protective effects. The investigators hypothesize that in women with prior GDM and glucose intolerance in early postpartum, treatment with semaglutide will reduce the risk to develop T2DM on the long-term compared to placebo.

Intervention and comparison: Belgian multi-centric double blind RCT with 13 centers to compare semaglutide (once weekly) with placebo in women with a recent history of GDM and glucose intolerance [impaired fasting glycaemia (IFG) and/or impaired glucose tolerance (IGT)] 6weeks - 12 months postpartum. Participants will be 1/1 randomized to semaglutide or placebo on a background of lifestyle measures. Semaglutide will be uptitrated to 1mg/week over a 8-week period. Participants will be followed-up for 3 years. Participants will receive a 75g oral glucose tolerance test (OGTT) 3-6 months after the stop of the intervention. Randomization will be stratified according to BMI at the early postpartum visit (<25; 25-29.9 and ≥30Kg/m²).

Outcomes: The primary endpoint is the development of T2DM by 160 weeks defined by fasting plasma glucose, OGTT and/or HbA1c according to the ADA criteria. Important secondary endpoints are assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication) and include:

Glycaemic outcomes

Need for glucose-lowering (rescue) therapy;
Frequency of prediabetes based on FPG, OGTT, and/or HbA1c;
Regression to normoglycaemia. Anthropometric and body composition outcomes
Change in body weight, BMI, waist circumference, waist-to-hip ratio;
Proportion of participants achieving ≥5%, ≥10%, and ≥15% weight loss;
Body fat percentage assessed by bioelectrical impedance analysis (Bodystat 1500®).

Insulin sensitivity and β-cell function

β-cell function, assessed by HOMA-B, insulinogenic index divided by HOMA-IR, insulin secretion-sensitivity index-2, and the Stumvoll index;
Insulin sensitivity, assessed by the Matsuda index (reflecting whole body insulin sensitivity) and 1/HOMA-IR, reflecting primarily hepatic insulin sensitivity.

Cardiometabolic risk factors

Prevalence of the metabolic syndrome;
Blood pressure (blood pressure ≥140/90 mmHg) and heart rate;
Lipid profile, including low density lipoprotein-cholesterol (LDL-cholesterol, ≥100 mg/dL or ≥2,6 mmol/L) and triglycerides (≥150 mg/dL or ≥1,7 mmol/L).

Patient-reported outcomes

Health-related quality of life assessed by SF-36 and EQ-5D-5L;
Symptoms of depression (CES-D) and anxiety (short-form STAI);
Treatment satisfaction assessed using a study-specific questionnaire based on the Diabetes Treatment Satisfaction Questionnaire;
Sleep quality (Pittsburgh Sleep Quality Index) and food security (short-form HFSSM).

Biomarker outcomes

Changes in and associations of metabolomic profiles, with cardiometabolic risk and treatment response.

Health economic outcomes

Quality-adjusted life years (QALYs);
Incremental costs and incremental cost-effectiveness ratio (ICER) of semaglutide compared with placebo.
Health economic analyses are considered exploratory and hypothesis-generating, as the study was primarily powered for the clinical endpoint of incident T2DM rather than economic outcomes.

To achieve 80% power, we plan a sample size of 252 to detect an estimated 50% reduction in the risk to develop T2DM between both groups, assuming a 30% loss to follow-up during the study.

Conditions: Glucose Intolerance After a Recent History of Gestational Diabetes
Being tested: Semaglutide Pen Injector, Semaglutide placebo
Keywords: gestational diabetes, glucose intolerance postpartum, prevention, type 2 diabetes, GLP-1 agonist, semaglutide
Medical subject headings: Diabetes, Gestational, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Semaglutide Pen InjectorDrug
Also called Ozempic
maintenance dose of 1mg SC once weekly
Semaglutide placeboDrug
maintenance dose of 1mg SC once weekly

Study groups in NCT05569772
Study group	Role	What they receive
semaglutide	Active comparator	semaglutide SC once weekly, up titration over 2 month period to 1mg/week (0.25mg once weekly, after 4 weeks 0.5mg once weekly and after 8 weeks the maintenance dose of 1mg once weekly), treatment duration of max. 3 years Receives: Drug: Semaglutide Pen Injector
placebo	Placebo comparator	placebo SC once weekly, the same dose-escalation regimen, using matching injections, treatment duration of max. 3 years Receives: Drug: Semaglutide placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Development of T2DM
Defined by FPG, OGTT, and/or HbA1c according to the ADA criteria
Measured: by 160 weeks

Secondary outcomes (33)

Need for glucose-lowering (rescue) therapy
Percentage need for rescue therapy for diabetes
Measured: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Frequency of prediabetes based on FPG, OGTT, and/or HbA1c
Percentage of prediabetes based on FPG, OGTT, and/or HbA1c
Measured: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Regression to normoglycaemia
Percentage regression to normoglycaemia, based on fasting glycaemia, oral glucose tolerance test and/or HbA1c (ADA criteria)
Measured: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Change in body weight
Change in body weight (kg)
Measured: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
BMI
Mean BMI (Kg/m2)
Measured: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Waist circumference
Mean waist circumference (cm)
Measured: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Waist-to-hip ratio
Waist/hip circumference ratio
Measured: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Proportion of participants achieving ≥5% weight loss
Percentage weight loss ≥5%
Measured: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Proportion of participants achieving ≥10% weight loss
Percentage weight loss ≥10%
Measured: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Proportion of participants achieving ≥15% weight loss
Percentage weight loss ≥15%
Measured: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Body fat percentage assessed by bioelectrical impedance analysis (Bodystat 1500®)
Percentage body fat measured by bioelectrical impedance analysis
Measured: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
β-cell function, assessed by HOMA-B
Beta-cell function measured by the HOMA-B index
Measured: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Insulinogenic index divided by HOMA-IR
Beta-cell function measured by the by the insulinogenic index divided by HOMA-insulin resistance index
Measured: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Insulin secretion-sensitivity index-2
Beta-cell function measured by theby the insulin-secretion sensitivity-2 index
Measured: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Stumvoll index
Beta-cell function measured by the Stumvoll index
Measured: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Insulin sensitivity, assessed by the Matsuda index (reflecting whole body insulin sensitivity)
Whole body Insulin sensitivity measured by the insulin sensitivity index of Matsuda
Measured: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
1/HOMA-IR, reflecting primarily hepatic insulin sensitivity
The reciprocal of the homeostasis model assessment of insulin resistance (1/HOMA-IR)
Measured: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Prevalence of the metabolic syndrome
Percentage of the metabolic syndrome based on the WHO criteria
Measured: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Blood pressure (blood pressure ≥140/90 mmHg)
Percentage blood pressure ≥140/90mmHg
Measured: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Heart rate
Mean heart rate
Measured: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Lipid profile, including low density lipoprotein-cholesterol (LDL-cholesterol, ≥100 mg/dL or ≥2,6 mmol/L)
Percentage LDL cholesterol ≥100mg/dl or ≥2,6 mmol/L
Measured: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Lipid profile, including triglycerides (≥150 mg/dL or ≥1,7 mmol/L)
Percentage triglycerides ≥150mg/dl or ≥1,7 mmol/L
Measured: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Health-related quality of life assessed by SF-36
Health-related quality of life assessed using the 36-Item Short Form Health Survey (SF-36). Scores range from 0 to 100, with higher scores indicating better health-related quality of life
Measured: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Health-related quality of life assessed by EQ-5D-5L
Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale (EQ VAS). Scores range from 0 to 100, with higher scores indicating better perceived health status
Measured: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Symptoms of depression (CES-D)
Depressive symptoms assessed using the 20-item Center for Epidemiologic Studies Depression Scale (CES-D). Total scores range from 0 to 60, with higher scores indicating more depressive symptoms
Measured: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Symptoms of anxiety (short-form STAI)
Symptoms of anxiety assessed using the 6-item short-form State-Trait Anxiety Inventory (STAI). Total scores range from 20 to 80 after score transformation, with higher scores indicating greater anxiety symptoms
Measured: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Treatment satisfaction assessed using a study-specific questionnaire based on the Diabetes Treatment Satisfaction Questionnaire
Diabetes risk perception assessed using the Diabetes Risk Perception Questionnaire, a validated questionnaire that evaluates perceived risk of developing diabetes
Measured: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Sleep quality (Pittsburgh Sleep Quality Index)
Sleep quality assessed using the validated Pittsburgh Sleep Quality Index (PSQI)
Measured: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Food security (short-form HFSSM)
Food security assessed using the short-form Household Food Security Survey Module (HFSSM). Scores indicate the level of food security, with higher scores reflecting greater food insecurity
Measured: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Plasma metabolite concentrations
Changes in and associations of metabolomic profiles, with cardiometabolic risk and treatment response. Assessed using metabolomic profiling. Blood samples will be collected at baseline and every 6 months during a 3.5-year follow-up period (study visits).
Measured: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Quality-adjusted life years (QALYs)
Quality-adjusted life years (QALYs), calculated as the area under the curve of health-related quality of life utility values over time, where higher values indicate better health outcomes
Measured: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Incremental costs and incremental cost-effectiveness ratio (ICER) of semaglutide compared with placebo
Incremental costs and incremental cost-effectiveness ratio (ICER) of semaglutide versus placebo
Measured: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Incremental healthcare costs
Incremental healthcare costs associated with the intervention compared with control, calculated from collected healthcare resource utilization and unit cost data. Currency (e.g., EUR per participant)
Measured: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Sep 2023May 2030

First posted6 Oct 2022
Study start14 Sep 2023
Primary completionMar 2030 (estimated)
Study completionMay 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Glucose Intolerance After a Recent History of Gestational DiabetesStudies of the same condition, open and under way.
More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: multi-centric double blind RCT
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 252 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05569772
Sponsor's protocol ID: S66967
Other IDs: 2022-502082-22-00
Acronym: SERENA
Status last verified: Sep 2026
First submitted: 28 Sep 2022
Last updated: 15 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data will be made available upon reasonable request after study completion, database lock, unblinding, and publication of the primary results, subject to applicable ethical, legal, and data protection requirements.

Publications

Vanlaer Y, Embo N, Bochanen N, Van Wilder N, Vereecke G, Wierckx K, Verhaegen A, Coremans P, Philips JC, Lytrivi M, Oriot P, Vandewalle S, Cuypers J, Deconinck B, Laenen A, Mathieu C, Benhalima K. Semaglutide for prevention of type 2 diabetes in women with postpartum prediabetes after gestational diabetes: protocol for a Belgian multicentre double-blind randomised placebo-controlled trial. BMJ Open. 2026 Jul 23;16(7):e118191. doi: 10.1136/bmjopen-2026-118191.
PubMed 42493207

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Semaglutide for the Treatment of Glucose Intolerance in Women With Prior Gestational Diabetes: a Double Blind RCT
ClinicalTrials.gov ID: NCT05569772
Acronym / sponsor ID: SERENA / S66967
Conditions: Glucose Intolerance After a Recent History of Gestational Diabetes
Keywords: gestational diabetes, glucose intolerance postpartum, prevention, type 2 diabetes, GLP-1 agonist, semaglutide
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 252 participants (estimated)
Lead sponsor: Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
Collaborators: University Hospital, Antwerp, Universitair Ziekenhuis Brussel, General Hospital Groeninge, Vitaz, Centre Hospitalier Universitaire de Liege, Erasme University Hospital, Centre Hospitalier Mouscron, Jan Yperman Ziekenhuis, AZ Turnhout, AZ Sint-Lucas Brugge, Ziekenhuis aan de Stroom, Onze Lieve Vrouw Hospital
Study start: 14 Sep 2023 (actual)
Primary completion: Mar 2030 (estimated)
Study completion: May 2030 (estimated)
First posted: 6 Oct 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Glycaemic outcomes

Need for glucose-lowering (rescue) therapy;
Frequency of prediabetes based on FPG, OGTT, and/or HbA1c;
Regression to normoglycaemia. Anthropometric and body composition outcomes
Change in body weight, BMI, waist circumference, waist-to-hip ratio;
Proportion of participants achieving ≥5%, ≥10%, and ≥15% weight loss;
Body fat percentage assessed by bioelectrical impedance analysis (Bodystat 1500®).

Insulin sensitivity and β-cell function

β-cell function, assessed by HOMA-B, insulinogenic index divided by HOMA-IR, insulin secretion-sensitivity index-2, and the Stumvoll index;
Insulin sensitivity, assessed by the Matsuda index (reflecting whole body insulin sensitivity) and 1/HOMA-IR, reflecting primarily hepatic insulin sensitivity.

Cardiometabolic risk factors

Prevalence of the metabolic syndrome;
Blood pressure (blood pressure ≥140/90 mmHg) and heart rate;
Lipid profile, including low density lipoprotein-cholesterol (LDL-cholesterol, ≥100 mg/dL or ≥2,6 mmol/L) and triglycerides (≥150 mg/dL or ≥1,7 mmol/L).

Patient-reported outcomes

Health-related quality of life assessed by SF-36 and EQ-5D-5L;
Symptoms of depression (CES-D) and anxiety (short-form STAI);
Treatment satisfaction assessed using a study-specific questionnaire based on the Diabetes Treatment Satisfaction Questionnaire;
Sleep quality (Pittsburgh Sleep Quality Index) and food security (short-form HFSSM).

Biomarker outcomes

Changes in and associations of metabolomic profiles, with cardiometabolic risk and treatment response.

Health economic outcomes

Quality-adjusted life years (QALYs);
Incremental costs and incremental cost-effectiveness ratio (ICER) of semaglutide compared with placebo.
Health economic analyses are considered exploratory and hypothesis-generating, as the study was primarily powered for the clinical endpoint of incident T2DM rather than economic outcomes.

To achieve 80% power, we plan a sample size of 252 to detect an estimated 50% reduction in the risk to develop T2DM between both groups, assuming a 30% loss to follow-up during the study.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
Model description: multi-centric double blind RCT

Arm	Type	Receives
semaglutide	Active comparator	Drug: Semaglutide Pen Injectorsemaglutide SC once weekly, up titration over 2 month period to 1mg/week (0.25mg once weekly, after 4 weeks 0.5mg once weekly and after 8 weeks the maintenance dose of 1mg once weekly), treatment duration of max. 3 years
placebo	Placebo comparator	Drug: Semaglutide placeboplacebo SC once weekly, the same dose-escalation regimen, using matching injections, treatment duration of max. 3 years

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Semaglutide Pen InjectorAlso: Ozempicmaintenance dose of 1mg SC once weekly	Drug	semaglutide
Semaglutide placebomaintenance dose of 1mg SC once weekly	Drug	placebo

Primary outcome

Development of T2DM
Time frame: by 160 weeks
Defined by FPG, OGTT, and/or HbA1c according to the ADA criteria

33 secondary outcomes

Need for glucose-lowering (rescue) therapy
Time frame: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Frequency of prediabetes based on FPG, OGTT, and/or HbA1c
Time frame: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Regression to normoglycaemia
Time frame: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Change in body weight
Time frame: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
BMI
Time frame: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Waist circumference
Time frame: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Waist-to-hip ratio
Time frame: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Proportion of participants achieving ≥5% weight loss
Time frame: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Proportion of participants achieving ≥10% weight loss
Time frame: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Proportion of participants achieving ≥15% weight loss
Time frame: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Body fat percentage assessed by bioelectrical impedance analysis (Bodystat 1500®)
Time frame: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
β-cell function, assessed by HOMA-B
Time frame: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Insulinogenic index divided by HOMA-IR
Time frame: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Insulin secretion-sensitivity index-2
Time frame: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Stumvoll index
Time frame: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Insulin sensitivity, assessed by the Matsuda index (reflecting whole body insulin sensitivity)
Time frame: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
1/HOMA-IR, reflecting primarily hepatic insulin sensitivity
Time frame: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Prevalence of the metabolic syndrome
Time frame: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Blood pressure (blood pressure ≥140/90 mmHg)
Time frame: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Heart rate
Time frame: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Lipid profile, including low density lipoprotein-cholesterol (LDL-cholesterol, ≥100 mg/dL or ≥2,6 mmol/L)
Time frame: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Lipid profile, including triglycerides (≥150 mg/dL or ≥1,7 mmol/L)
Time frame: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Health-related quality of life assessed by SF-36
Time frame: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Health-related quality of life assessed by EQ-5D-5L
Time frame: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Symptoms of depression (CES-D)
Time frame: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Symptoms of anxiety (short-form STAI)
Time frame: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Treatment satisfaction assessed using a study-specific questionnaire based on the Diabetes Treatment Satisfaction Questionnaire
Time frame: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Sleep quality (Pittsburgh Sleep Quality Index)
Time frame: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Food security (short-form HFSSM)
Time frame: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Plasma metabolite concentrations
Time frame: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Quality-adjusted life years (QALYs)
Time frame: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Incremental costs and incremental cost-effectiveness ratio (ICER) of semaglutide compared with placebo
Time frame: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)
Incremental healthcare costs
Time frame: Assessed at 160 weeks (end of treatment) and at 172-184 weeks (3-6 months after discontinuation of study medication)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
Results publication: PubMed 42493207Vanlaer Y, Embo N, Bochanen N, Van Wilder N, Vereecke G, Wierckx K, Verhaegen A, Coremans P, Philips JC, Lytrivi M, Oriot P, Vandewalle S, Cuypers J, Deconinck B, Laenen A, Mathieu C, Benhalima K. Semaglutide for prevention of type 2 diabetes in women with postpartum prediabetes after gestational diabetes: protocol for a Belgian multicentre double-blind randomised placebo-controlled trial. BMJ Open. 2026 Jul 23;16(7):e118191. doi: 10.1136/bmjopen-2026-118191.
Semaglutide for prevention of type 2 diabetes in women with postpartum prediabetes after gestational diabetes: protocol for a Belgian multicentre double-blind randomised placebo-controlled trialLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Individual participant data will be made available upon reasonable request after study completion, database lock, unblinding, and publication of the primary results, subject to applicable ethical, legal, and data protection requirements.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Katrien Benhalima, MD PhD contact

16340614 ext. 32

katrien.benhalima@uzleuven.be

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Semaglutide Pen Injector in people with Glucose Intolerance After a Recent History of Gestational Diabetes, run by Universitaire Ziekenhuizen KU Leuven at 13 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Katrien Benhalima, MD PhD (16340614 ext. 32, katrien.benhalima@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Development of T2DM (time frame: by 160 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05569772, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.