DECLARED-CT

RecruitingPhase NA

Menopausal Hormone Therapy, GLP-1 Agonists, and Glucose and Energy Homeostasis in Postmenopausal Women With Diabetes

Effects of Combined Menopausal Hormone Therapy and GLP-1 Receptor Agonist Therapy on Glucose and Energy Homeostasis in Early Postmenopausal Women With or at Risk of Diabetes

Lead sponsor

Lia Bally

Assets

GLP-1 / incretin class catch-all / Semaglutide

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Obesity / overweight, Prediabetes / glucose intolerance, Reproductive / infertility, Type 2 diabetes

Key I/E criteria

•BMI ≥27•HbA1c 5.7-8.5%•Female

Primary endpoint

•HbA1c, change

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 IDNCT06715514

Org study IDDECLARED-CT

Secondary ID10000574Swiss National Science Foundation

Secondary ID2024-01882BASEC-ID

Timeline

Milestones

Study first posted2024-12-04actual

Study start2025-02-18actual

Last update posted2025-03-06actual

Primary completion2026-08-31estimated

Study completion2026-08-31estimated

Assets

Investigational agents

GLP-1 / incretin class catch-all Semaglutide

Study populations

Who this study enrolls

Obesity / overweightPrediabetes / glucose intoleranceReproductive / infertilityType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexFemale

Healthy volunteersNot accepted

Eligibility criteria

Individuals fulfilling at enrolment all of the following inclusion criteria are eligible for the study:

•Early postmenopausal status (STRAW+10 stage +1b or +1c and FSH>25.0mU/L)

•Presence of menopausal symptoms (total MRS-II score ≥1)

•BMI ≥ 27.0kg/m2

•Pre- or existing type 2 diabetes (HbA1c 5.7%-8.5%)

•No prior or current use of MHT

The presence of any of the following exclusion criteria will lead to exclusion of the individuals:

•DPP4-inhibitor, SLGT2-inhibitor or sulfonylurea use within 8 weeks prior to study enrolment

•GLP-1RA use within 6 months prior to study enrolment

•Insulin therapy within 8 weeks prior to study enrolment

•History of bariatric surgery

•More than 2% change in body weight within three months prior to study enrolment (based on documented or reported weights)

•Contraindications for the use of the study medication as per prescription labelling: Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2

•Known or suspected cancer of breast or other sexual organ, abnormal genital bleeding of unknown cause, hepatic neoplasia

•Arterial or venous thromboembolic events, porphyria

•Known allergy or hypersensitivity to Wegovy®, Estradot® or Utrogestan® (pharmaceutical agents or any of the excipients)

•Systemic hormone therapy or hormonal contraceptives (e.g. estrogens, progestogens, androgens) during the study and within 12 months prior to participation

•Herbal remedies and complimentary medicines for menopausal symptoms during the study

•Physical or psychological condition or any medical intervention (including medication not specified above) likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator

•Participation in another clinical trial that interferes with the interpretation of the study results

•Inability to read German

•Unwillingness to follow the study procedures

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

Other (unclassified)

Weight & body composition

Patient-reported / QoL

Other clinical outcomes

Cardiometabolic biomarkers

MASH / liver

Weight & body composition

3 endpoints

Secondary/protocol endpoint

Change in body weight

Time frame:12 Weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in body fat percentage

Time frame:12 Weeks

Total fat mass

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in resting energy expenditure

Time frame:12 Weeks

change from baseline, descriptive

Glycemic / diabetes

14 endpoints

Primary/protocol endpoint

Change in HbA1C

Time frame:12 Weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in postprandial plasma glucose exposure during the OGTT (AUC plasma glucose concentration)

Time frame:12 Weeks

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in average sensor glucose levels

Time frame:12 Weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in time with sensor glucose in tight target range [3.9-7.8 mmol/L]

Time frame:12 Weeks

CGM time-in-range

change from baseline, improvement

Secondary/protocol endpoint

Change in fasting plasma glucose levels

Time frame:12 Weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in whole-body insulin sensitivity

Time frame:12 Weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in incretin effect

Time frame:12 Weeks

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in glucose rate of appearance

Time frame:12 Weeks

change from baseline, improvement

Other/protocol endpoint

Change in beta-cell function

Time frame:12 Weeks

change from baseline, improvement

Other/protocol endpoint

Change in beta-cell glucose responsivity

Time frame:12 Weeks

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in beta-cell GLP-1 sensitivity

Time frame:12 Weeks

change from baseline, improvement

Other/protocol endpoint

Change in GLP-1 potentiation of insulin secretion

Time frame:12 Weeks

change from baseline, improvement

Other/protocol endpoint

Change in production ("hepatic") insulin sensitivity

Time frame:12 Weeks

change from baseline, improvement

Other/protocol endpoint

Change in disposal ("peripheral") insulin sensitivity

Time frame:12 Weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

MASH / liver

1 endpoint

Secondary/protocol endpoint

Change in liver fat (controlled attenuation parameter)

Time frame:12 Weeks

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Change in non-HDL cholesterol

Time frame:12 Weeks

Non-HDL cholesterol, change

change from baseline, improvement

Secondary/protocol endpoint

Change in systolic blood pressure

Time frame:12 Weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Patient-reported / QoL

3 endpoints

Secondary/protocol endpoint

Change in quality of life

Time frame:12 Weeks

EQ-5D index

change from baseline, improvement

Secondary/protocol endpoint

Change in postmenopausal symptoms burden

Time frame:12 Weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in intensity of vasomotor symptoms

Time frame:12 Weeks

change from baseline, improvement

Other clinical outcomes

3 endpoints

Secondary/protocol endpoint

Change in frequency of vasomotor symptoms

Time frame:12 Weeks

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in meal frequency

Time frame:12 Weeks

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in diet composition

Time frame:12 Weeks

change from baseline, descriptive

Other (unclassified)

4 endpoints

Other/protocol endpoint/low confidence

Change in gastric emptying

Time frame:12 Weeks

change from baseline, descriptive

Other/protocol endpoint/low confidence

Change in GLP-1 secretion

Time frame:12 Weeks

change from baseline, descriptive

Other/protocol endpoint/low confidence

Change in energy intake

Time frame:12 Weeks

change from baseline, descriptive

Other/protocol endpoint/low confidence

Change in total energy expenditure

Time frame:12 Weeks

change from baseline, descriptive

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.