NCT07373834 Tirzepatide and Muscle Outcomes in Obesity
| NCT ID | NCT07373834 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Medical Centre Ljubljana |
| Condition | Obesity (Disorder) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2026-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Mojca Jensterle Sever, Prof.MD, PhD
PRINCIPAL INVESTIGATOR
Department of Endocrinology, Diabetes and Metabolic Diseases, University Medical Centre Ljubljana
Frequently Asked Questions
Who can join the NCT07373834 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Obesity (Disorder). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07373834 currently recruiting?
Yes, NCT07373834 is actively recruiting participants. Contact the research team at mojca.jensterlesever@kclj.si for enrollment information.
Where is the NCT07373834 trial being conducted?
This trial is being conducted at Ljubljana, Slovenia.
Who is sponsoring the NCT07373834 clinical trial?
NCT07373834 is sponsored by University Medical Centre Ljubljana. The principal investigator is Mojca Jensterle Sever, Prof.MD, PhD at Department of Endocrinology, Diabetes and Metabolic Diseases, University Medical Centre Ljubljana. The trial plans to enroll 30 participants.
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