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RecruitingPhase 2

Effects of Tirzepatide on Muscle and Vascular Health in Obese Older Adults

The Effects of Tirzepatide Use on Muscle and Vascular Function Among Obese Older Adults

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

1

Enrollment

20

estimated

Study population

Obesity / overweight

Key I/E criteria

BMI ≥30HbA1c ≤6.5%

Primary endpoints

Lean massMuscle Strength6-minute walk distance

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 IDNCT06811324
Org study IDSTUDY00001208

Timeline

Milestones

Study first posted2025-02-06actual
Study start2026-04-01actual
Last update posted2026-04-15actual
Primary completion2027-04-01estimated
Study completion2027-06-01estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age50 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Men and postmenopausal women aged 50 years or older.
Body Mass Index (BMI) ≥30 kg/m².
Untreated HbA1c <6.5% at baseline.
Willingness and ability to comply with all study procedures, including fasting requirements for certain visits.
Able to provide informed consent and participate in all study assessments.

Exclusion criteria

Active diagnosis of type 2 diabetes mellitus (T2DM), defined by active use of glucose-lowering medications or hemoglobin A1c ≥ 6.5%.
Body Mass Index (BMI) ≥ 40 kg/m².
Moderate to severe gastroesophageal reflux disease based on patient history.
Inability to comply with the treatment protocol or to understand the consent form.
Chronic Kidney Disease (CKD) Stage 4.
Aspartate aminotransferase (AST) > 33 U/L or alanine aminotransferase (ALT) > 36 U/L.
Active pregnancy.
Personal or family history of medullary thyroid carcinoma.
Personal or family history of multiple endocrine neoplasia type 2 syndrome.
Personal history of gastroparesis.
Personal history of diabetic retinopathy.
Known serious hypersensitivity, including anaphylaxis and angioedema, to Tirzepatide or any of its excipients.
Known serious hypersensitivity, including anaphylaxis and angioedema, to any GLP-1 receptor agonist class of therapies.
Concomitant treatment with GLP-1 receptor agonist therapy

Endpoints (3)

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
2
Heart failure
1

Weight & body composition

2 endpoints
Primary/protocol endpoint

Appendicular lean muscle mass

Time frame:6 months

Lean mass

change from baseline, improvement

Primary/protocol endpoint/low confidence

Muscle Strength

Time frame:6 months

change from baseline, improvement

Heart failure

1 endpoint
Primary/protocol endpoint

Lower Extremity Functional Capacity

Time frame:6 months

6-minute walk distance

change from baseline, improvement

Publications (13)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.