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Clinical Trials in Switzerland / NCT06715514
Active, not recruiting Not applicable

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

NCT06715514 · tracked via the Priya Life Science Switzerland tracker
Sponsor
Lia Bally
Phase
Not applicable
Started
2025-02-18
Last updated
2026-08-04

Condition(s) studied

MenopauseType 2 Diabetes

Investigational drug(s) / intervention(s)

GLP-1 Receptor Agonist →Menopausal Hormone Therapy →

GLP-1 Receptor Agonist: Wegovy®

Menopausal Hormone Therapy: Estradot® and Utrogestan®\* (in women with intact uterus\*)

Study summary

The overall aim is to investigate the hypothesis that restoring E2 levels through MHT improves glucose and energy homeostasis and potentiates the beneficial effects of GLP-1RA in early postmenopausal women with pre- or existing type 2 diabetes.

The primary objective is to assess the efficacy of combined MHT and GLP-1RA in improving glucose control in early postmenopausal women with pre- or existing type 2 diabetes, compared to GLP-1RA alone. Secondary objectives include efficacy analyses on body weight, other measures of cardiometabolic health, lifestyle behaviour, menopausal symptoms, and the exploration of mechanisms underpinning potential glycaemic and weight control benefits, and biomarkers of haemostasis.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University Hospital Bern Bern Switzerland

Other trials for the same condition

Closed-Loop Impact on Chronic Kidney Disease in Type 2 Diabetes Recruiting
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Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide Active, not recruiting
Time-Restricted Eating in Menopause and HOrmone-sensitive Breast Cancers (TREMHO) Recruiting
No More Sleepless Nights in Perimenopause Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06715514 on ClinicalTrials.gov ↗ ← All trials in Switzerland