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Recruiting NCT07373834

Tirzepatide and Muscle Outcomes in Obesity

No phase Interventional Obesity (Disorder)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tirzepatide, Placebo.
Who it may be relevant to
Registry conditions: Obesity (Disorder). Basic parameters: 18 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Slovenia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effects of Tirzepatide on Skeletal Muscle in Obesity

Overview

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.

Interventions

  • Drug Tirzepatide
    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.
  • Drug Placebo
    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 outcome measures

  • Change in Body Mass and Composition [Time frame: Baseline to Week 24]
  • Change in Quadriceps Muscle Strength [Time frame: Baseline to Week 24]
Secondary outcome measures (5)
  • Change in MRI-derived Skeletal Muscle Composition and Myosteatosis [Time frame: Baseline to Week 24]
  • Change in Molecular Markers in Vastus Lateralis Muscle: Gene-level Differential Expression [Time frame: Baseline to Week 24]
  • Change in Molecular Markers in Vastus Lateralis Muscle: Pathway-level Enrichment Analysis [Time frame: Baseline to Week 24]
  • Change in Intramyocellular Lipid Content (IMCL) in Vastus Lateralis Muscle [Time frame: Baseline to Week 24]
  • Change in the Muscle Fiber Diameter of Type I and Type II Fibers [Time frame: Baseline to Week 24]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Slovenia · 1 center
  • Department of Endocrinology, Diabetes and Metabolic Diseases, University Medical Centre Lj — Ljubljana

Identifiers

NCT: NCT07373834 · TIRMO-0120-121/2025-2711-6

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗