Tirzepatide effects on skeletal muscle in women with obesity
Official title: Effects of Tirzepatide on Skeletal Muscle in Obesity
Run by University Medical Centre Ljubljana · NCT07373834 · Data updated 2026-11-12
This trial will test whether tirzepatide changes muscle strength, size, quality, and metabolism in premenopausal adult women with obesity over 24 weeks.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 30 (estimated) |
| Sponsor | University Medical Centre Ljubljana Academic / other |
| Locations | 1 site (Ljubljana) |
| Status | Recruiting |
| Started | January 2026 |
| Main results expected | December 2026 |
| Study ends | March 2027 |
| Registry record updated | January 28, 2026 |
| Trial ID | NCT07373834 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are premenopausal females aged 18–50 with BMI 30–40 kg/m², stable weight over the prior three months, no prior pharmacologic or surgical obesity treatments, and willing to use barrier contraception.
✕Probably not a fit
People who are postmenopausal, male, have sarcopenic obesity, diabetes, recent pancreatitis, myopathy, active malignancy, are pregnant or lactating, or are taking metformin or systemic corticosteroids are excluded and likely would not benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adult premenopausal women with obesity (BMI 30–40 kg/m²) will be assigned to receive tirzepatide or matching placebo for 24 weeks. Investigators will track body weight and composition, measure muscle strength and functional performance, and evaluate neuromuscular function. Muscle biopsies taken before and after treatment will undergo molecular and histological analyses to characterize changes in muscle metabolism, fiber structure, and quality. The trial excludes participants with diabetes, sarcopenic obesity, recent obesity treatments, and other specified medical conditions.
Why it matters
Potential benefit: If successful, the trial could show that tirzepatide preserves or improves muscle mass, quality, and function during weight loss, helping to reduce the risk of functional decline in women with obesity.
How similar studies have gone: GLP-1 and dual GIP/GLP-1 agonists, including tirzepatide, have produced substantial weight loss and favorable body composition changes in other trials, but direct biopsy-level effects on skeletal muscle are not well established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female sex * Age between 18 and 50 years * BMI between 30 kg/m² and 40 kg/m² * Stable body weight within the three months preceding study enrolment (defined as ≤ 5% change) * No prior pharmacological or surgical interventions for obesity treatment * Commitment to use barrier contraception and absence of plans for pregnancy within 8 months following enrolment Exclusion Criteria: * Sarcopenic obesity * Pregnancy or lactation * Postmenopausal status * Diabetes * Immobility * Personal history of malignancy * Personal history of pancreatitis * Personal history of major depressive episodes * Personal history of myopathy * Personal or family history of medullary thyroid carcinoma * Current treatment with metformin or systemic corticosteroids
Where it's running
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Department of Endocrinology, Diabetes and Metabolic Diseases, University Medical Centre Ljubljana
Ljubljana, Slovenia Recruiting
Study contacts
- Principal investigator: Mojca Jensterle Sever, Prof.MD, PhD — Department of Endocrinology, Diabetes and Metabolic Diseases, University Medical Centre Ljubljana
- Study coordinator: Prof. Mojca Jensterle Sever, MD, PhD
- Email: mojca.jensterlesever@kclj.si
- Phone: 0038631312977
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.