Clinical trial

Tirzepatide and Muscle Outcomes in Obesity

Recruiting now · Not applicable · 1 countries · Registry ID NCT07373834

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 50 Years

SexFemale

Healthy volunteersNot accepted

ConditionObesity (Disorder)

Full registry 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

Treatments and study arms

Tirzepatide

Drug

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.

Placebo

Drug

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.

Primary outcomes

Change in Body Mass and CompositionBaseline to Week 24

Measured primarily as changes in body weight and body composition measured by dual-energy X-ray absorptiometry (DXA).

Change in Quadriceps Muscle StrengthBaseline to Week 24

Change in maximal knee extensor torque normalized to body mass (Nm/kg) will be evaluated using an isokinetic dynamometer.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Department of Endocrinology, Diabetes and Metabolic Diseases, University Medical Centre Ljubljana🌐 Ljubljana, Slovenia

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Prof. Andrej Janež, MD, PhDContact

Email · Call 0038615223564

Prof. Mojca Jensterle Sever, MD, PhDPrincipal Investigator