What this trial studies
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.
Conditions in scope
- Menopause
- Type 2 Diabetes
Interventions
- GLP-1 Receptor Agonist (Drug) — Wegovy®
- Menopausal Hormone Therapy (Drug) — Estradot® and Utrogestan®* (in women with intact uterus*)
Who can join
Women only · Ages 18 Years and up
Inclusion criteria
- 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
Exclusion criteria
- 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
Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.
Where it’s happening
| City | State / Region | Facility | Site status |
|---|---|---|---|
| Bern | University Hospital Bern | Recruiting |
Status & timeline
- Overall status: Recruiting
- Study type: Interventional
- Phase: N/A
- Start date: 2025-02-18
- Primary completion: 2026-08-31
- Last update posted: 2025-03-06
- First posted: 2024-12-04
Sponsor & contact
Lead sponsor: Lia Bally (Other)
For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.
Outcome measures
Primary outcomes
- Change in HbA1C (12 Weeks)
Change in HbA1C from Baseline (Visit 1a) to Visit 2a (units: percentage points). The primary outcome will be compared between the combined MHT+GLP-1RA arm and the GLP-1RA only arm.
Related ClearedRx care
If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.
Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT06715514 before contacting a site.
ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.