Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
FEMALE
NCT07373834

Tirzepatide and Muscle Outcomes in Obesity

Led by University Medical Centre Ljubljana · Updated on 2026-01-28

30

Participants Needed

1

Research Sites

60 weeks

Total Duration

On this page

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

Tirzepatide and Muscle Outcomes in Obesity

Who Can Participate

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female sex
  • Age between 18 and 50 years
  • BMI between 30 kg/m² and 40 kg/m²
  • Stable body weight within the three months before enrollment (no more than 5% change)
  • No previous pharmacological or surgical treatment for obesity
  • Commitment to use barrier contraception and no plans for pregnancy within 8 months after enrollment
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

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

Ljubljana, Slovenia, 1000

Actively Recruiting

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Research Team

P

Prof. Mojca Jensterle Sever, MD, PhD

CONTACT

A

Andrijana Koceva, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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