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TIRMO

RecruitingPhase NA

Tirzepatide and Muscle Outcomes in Obesity

Effects of Tirzepatide on Skeletal Muscle in Obesity

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

1

Enrollment

30

estimated

Study population

Obesity / overweight

Key I/E criterion

Female

Primary endpoints

Body Mass and Composition (Body weight, absolute change (kg), Total fat mass, Lean mass)Quadriceps Muscle Strength

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07373834
Org study IDTIRMO-0120-121/2025-2711-6

Timeline

Milestones

Study first posted2026-01-28actual
Last update posted2026-01-28actual
Study start2026-01estimated (month precision)
Primary completion2026-12estimated (month precision)
Study completion2027-03estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age50 Years
SexFemale
Healthy volunteersNot accepted

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

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
4
Other clinical outcomes
4
Other (unclassified)
3
Heart failure
1

Weight & body composition

4 endpoints
Primary/protocol endpoint

Change in Body Mass and Composition

Time frame:Baseline to Week 24

change from baseline, improvement

componentsBody weight, absolute change (kg), Total fat mass, Lean mass

Secondary/protocol endpoint/low confidence

Change in MRI-derived Skeletal Muscle Composition and Myosteatosis

Time frame:Baseline to Week 24

change from baseline, improvement

componentsLean mass, Total fat mass

Secondary/protocol endpoint

Change in Intramyocellular Lipid Content (IMCL) in Vastus Lateralis Muscle

Time frame:Baseline to Week 24

change from baseline, improvement

Secondary/protocol endpoint

Change in the Muscle Fiber Diameter of Type I and Type II Fibers

Time frame:Baseline to Week 24

change from baseline, improvement

Heart failure

1 endpoint
Other/protocol endpoint

Change in 6-Minute Walk Test (6MWT)

Time frame:Baseline to Week 24

6-minute walk distance

change from baseline, improvement

Other clinical outcomes

4 endpoints
Primary/protocol endpoint

Change in Quadriceps Muscle Strength

Time frame:Baseline to Week 24

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in Handgrip Strenght

Time frame:Baseline to Week 24

change from baseline, improvement

Other/protocol endpoint

Changes in Lower-Limb Functional Performance

Time frame:Baseline to Week 24

change from baseline, improvement

Other/protocol endpoint/low confidence

Electrophysiological Assessment of Motor Responses in Skeletal Muscles

Time frame:Baseline to Week 24

change from baseline, descriptive

Other (unclassified)

3 endpoints
Secondary/protocol endpoint/low confidence

Change in Molecular Markers in Vastus Lateralis Muscle: Gene-level Differential Expression

Time frame:Baseline to Week 24

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in Molecular Markers in Vastus Lateralis Muscle: Pathway-level Enrichment Analysis

Time frame:Baseline to Week 24

descriptive

Other/protocol endpoint

Spatial Transcriptomics Analysis of Vastus Lateralis Muscle Biopsy Samples

Time frame:Baseline to Week 24

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.