Tirzepatide effects on skeletal muscle in women with obesity
Effects of Tirzepatide on Skeletal Muscle in Obesity
This trial will test whether tirzepatide changes muscle strength, size, quality, and metabolism in premenopausal adult women with obesity over 24 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | University Medical Centre Ljubljana Academic / other |
| Locations | 1 site (Ljubljana) |
| Trial ID | NCT07373834 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Ljubljana
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.