DelfaGLP-1 Atlas

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SERENA

RecruitingPhase 3

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

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

Assets

GLP-1 / incretin class catch-all / Semaglutide

Listed sites

13

Recruiting sites

13

Enrollment

252

estimated

Study population

Gestational diabetes, Prediabetes / glucose intolerance

Key I/E criterion

•Female

Primary endpoint

•Time to T2DM onset

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05569772
Org study IDS66967
Secondary ID2022-502082-22-00EU CT number

Timeline

Milestones

Study first posted2022-10-06actual
Study start2023-09-14actual
Last update posted2026-06-02actual
Primary completion2029-06estimated (month precision)
Study completion2029-12estimated (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-allSemaglutide

Study populations

Who this study enrolls

Gestational diabetesPrediabetes / glucose intolerance

Eligibility

Who can enroll

Minimum age18 Years
SexFemale
Healthy volunteersNot accepted

Inclusion criteria

1. Voluntary written informed consent of the participant has been obtained prior to any screening procedures

2. Women aged ≥18 years

3. Use of highly effective methods of birth control

4. History of GDM diagnosed according to the 2013 WHO criteria (at 24-32 weeks gestation or <24 weeks for early GDM)

5. Diagnosis of prediabetes 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%])

Exclusion criteria

1. Presence of autoantibodies suggestive of type 1 diabetes, normal glucose tolerance, history of pancreatitis, previous bariatric surgery or planned surgery within two years

2. Unable to understand and speak Dutch, French or English

3. Female who is pregnant or intends to become pregnant within the next year

4. Female who wants to give breastfeeding >22 months

5. Use of medication with significant impact on glycaemia (such as high dose glucocorticoids or metformin)

Endpoints (30)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
11
Weight & body composition
7
Patient-reported / QoL
5
Cardiometabolic biomarkers
4
Safety / tolerability / PK
2
Other clinical outcomes
1

Weight & body composition

7 endpoints
Secondary/protocol endpoint

BMI

Time frame:by 160 weeks

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

waist circumference

Time frame:by 160 weeks

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

waist/hip ratio

Time frame:by 160 weeks

ratio, improvement

Secondary/protocol endpoint

5% weight loss

Time frame:by 160 weeks

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

10% weight loss

Time frame:by 160 weeks

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

15% weight loss

Time frame:by 160 weeks

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

body fat percentage

Time frame:by 160 weeks

Total fat mass

change from baseline, improvement

Glycemic / diabetes

11 endpoints
Primary/protocol endpoint

type 2 diabetes

Time frame:by 160 weeks

Time to T2DM onset

time to event, event

Secondary/protocol endpoint

medication for diabetes

Time frame:by 160 weeks

threshold achievement, event

Secondary/protocol endpoint

prediabetes

Time frame:by 160 weeks

categorical status, improvement

Secondary/protocol endpoint

normoglycaemia

Time frame:by 160 weeks

threshold achievement, improvement

Secondary/protocol endpoint

HOMA-B index

Time frame:by 160 weeks

change from baseline, improvement

Secondary/protocol endpoint

insulinogenic index

Time frame:by 160 weeks

change from baseline, improvement

Secondary/protocol endpoint

ISSI-2 index

Time frame:by 160 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

the Stumvoll index.

Time frame:by 160 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Matsuda index

Time frame:by 160 weeks

descriptive, improvement

Secondary/protocol endpoint

HOMA-IR

Time frame:by 160 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

diabetes remission

Time frame:by 172-184 weeks (3-6 months after end of therapy)

categorical status, improvement

Cardiometabolic biomarkers

4 endpoints
Secondary/protocol endpoint

Hypertension

Time frame:by 160 weeks

threshold achievement, improvement

Secondary/protocol endpoint

heart rate

Time frame:by 160 weeks

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

LDL cholesterol

Time frame:by 160 weeks

LDL-C, change

threshold achievement, improvement

LOINC 13457-7

Secondary/protocol endpoint

Triglycerides

Time frame:by 160 weeks

Triglycerides, change

threshold achievement, improvement

LOINC 2571-8

Patient-reported / QoL

5 endpoints
Secondary/protocol endpoint

self-reported quality of life

Time frame:by 160 weeks

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

symptoms of depression

Time frame:by 160 weeks

descriptive, improvement

Secondary/protocol endpoint/low confidence

anxiety

Time frame:by 160 weeks

descriptive, improvement

Secondary/protocol endpoint

Diabetes risk perception

Time frame:by 160 weeks

descriptive

Secondary/protocol endpoint

sleep quality

Time frame:by 160 weeks

descriptive, improvement

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

hypoglycaemia

Time frame:by 160 weeks

Documented hypoglycemia

threshold achievement, event

Secondary/protocol endpoint

gastro-intestinal side effects

Time frame:by 160 weeks

threshold achievement, event

componentsNausea, Vomiting, Diarrhea

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

metabolic syndrome

Time frame:by 160 weeks

threshold achievement, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.