RecruitingNot ApplicableNCT07373834

Tirzepatide and Muscle Outcomes in Obesity

Effects of Tirzepatide on Skeletal Muscle in Obesity

Sponsor

University Medical Centre Ljubljana

Enrollment

30 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Obesity (Disorder)

Summary

This study is evaluating whether a dual glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist, tirzepatide, can affect the function, structure and metabolism of skeletal muscles in adults with obesity. Participants, premenopausal females with obesity, will receive either tirzepatide or placebo over 24 weeks. Researchers will assess body weight, body composition, muscle strength and functional performance, neuromuscular function and will perform muscle biopsies before and after treatment to study molecular and histological changes following treatment. The goal of this study is to investigate the effects of tirzepatide on skeletal muscle function, quantity, quality and metabolism in adults with obesity as well as clarify the molecular and structural adaptations in skeletal muscle during tirzepatide-induced weight loss, addressing an important gap in understanding the impact of incretin-based therapies on muscle health.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study investigates what happens to skeletal muscle — its function, structure, and metabolism — when premenopausal women with obesity lose weight using tirzepatide, a dual GLP-1/GIP receptor agonist medication approved for weight management. Rapid weight loss can sometimes cause muscle loss, and this study aims to understand whether tirzepatide-induced weight loss preserves or affects muscle health. Premenopausal women aged 18 to 50 with a BMI between 30 and 40 who have not previously used weight-loss medications or had bariatric surgery may be eligible, while women with diabetes, pregnancy, history of cancer, pancreatitis, or myopathy are excluded. Participation involves receiving tirzepatide or placebo injections for 24 weeks, with assessments of body composition, strength, muscle biopsies, and neuromuscular function at the start and end of the study. This summary was generated with AI assistance to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTirzepatide

Tirzepatide is a dual glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist. It will be administered via subcutaneous injection once weekly in a dose-titration scheme: starting at 2.5 mg and increased every 4 weeks by 2.5 mg up to a maximum of 15 mg, based on tolerability.

DRUGPlacebo

Placebo (saline solution) will be administered via subcutaneous injection once weekly with dose escalation following the same schedule (2.5 mg equivalent increments every 4 weeks) to preserve blinding integrity.