NCT06715514Active, not recruiting
Menopausal Hormone Therapy, GLP-1 Agonists, and Glucose and Energy Homeostasis in Postmenopausal Women With Overweight/Obesity and Impaired Glucose Homeostasis
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
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 96 (estimated)
- First submitted
- 28 Nov 2024
- Start date
- 18 Feb 2025
- Primary completion date
- 17 Dec 2026
- Lead sponsor
- Lia Bally
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT06715514
What you commit to
- Study type: Interventional
- Planned participants: 96
- From 18 Feb 2025 to the primary completion date, 17 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Bern Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.