Tirzepatide for Muscle Health

Overseen By Suha Soni

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: The University of Texas Health Science Center at San Antonio

Must not be taking: Glucose-lowering, GLP-1 agonists

Disqualifiers: T2DM, BMI ≥ 40, CKD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using glucose-lowering medications or GLP-1 receptor agonist therapy.

How does the drug Tirzepatide differ from other treatments for muscle health?

Tirzepatide is unique because it is primarily known for its use in managing blood sugar levels in type 2 diabetes, and its application for muscle health is novel. Unlike other treatments that focus on metabolic reprogramming or muscle activation, Tirzepatide's potential benefits for muscle health are still being explored, making it a new area of research. ^{1 2 3 4 5}

What is the purpose of this trial?

Obesity and type 2 diabetes mellitus (T2DM) represent major public health concerns in the aging Hispanic community. Tirzepatide, a novel dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist recently approved for the treatment of T2DM and obesity has been shown to be effective at reducing weight, improving markers of T2DM control, and improving cardiovascular health. Utilization of tirzepatide in the Hispanic community has been on the rise since FDA approval was issued, however the effects of tirzepatide use on functional outcomes in older Hispanic adults with obesity are not well established. Recent studies show that weight loss caused by tirzepatide may be driven by substantial loss of lean muscle mass, which may contribute to weakness and frailty, particularly among older adults. The proposed pilot study aims to evaluate how treatment with tirzepatide for 6 months affects muscle mass and function among older Hispanic adults, and if changes in muscle mass are linked to changes in functional status over the same time period.

Research Team

Shreya Rao, MD, MPH

Principal Investigator

The University of Texas Health Science Center at San Antonio

Tiffany Cortes, MD

Principal Investigator

The University of Texas Health Science Center at San Antonio

Elena Volpi, MD, PhD

Principal Investigator

The University of Texas Health Science Center at San Antonio

Eligibility Criteria

This trial is for older Hispanic adults who are obese and may also have type 2 diabetes. Participants should be interested in how a new medication, Tirzepatide, affects muscle mass and cardiovascular health during weight loss. Specific eligibility criteria were not provided.

Inclusion Criteria

Body Mass Index (BMI) ≥30 kg/m²

Willingness and ability to comply with all study procedures, including fasting requirements for certain visits

Untreated HbA1c <6.5% at baseline

Exclusion Criteria

Active pregnancy

Personal history of gastroparesis

Known serious hypersensitivity, including anaphylaxis and angioedema, to any GLP-1 receptor agonist class of therapies

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Tirzepatide self-administered once weekly by subcutaneous injection

6 months

Follow-up

Participants are monitored for changes in muscle mass, strength, and functional capacity

6 months

Treatment Details

Interventions

• Tirzepatide

Trial Overview The study tests the effects of Tirzepatide on muscle and vascular health over six months. It focuses on whether this medication, which helps with weight loss and diabetes control, leads to muscle loss that could cause frailty in older Hispanic adults.

Participant Groups

Group I: Tirzepatide Experimental Treatment 1 Intervention

Tirzepatide self-administered once weekly by subcutaneous injection

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

Findings from Research

Tirasemtiv, a muscle activator, was found to be well tolerated at doses up to 500 mg daily over three weeks, with dizziness being the most common side effect.

The study showed promising trends in improving functional outcomes in patients, such as muscle strength and endurance, suggesting that tirasemtiv could be beneficial for further research in treating ALS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A study to evaluate safety and tolerability of repeated doses of tirasemtiv in patients with amyotrophic lateral sclerosis. Shefner, JM., Watson, ML., Meng, L., et al.[2015]

References

1. France pubmed.ncbi.nlm.nih.gov

Identification of the optimal dose and calpain system regulation of tetramethylpyrazine on the prevention of skeletal muscle atrophy in hindlimb unloading rats. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Modulating the metabolism by trimetazidine enhances myoblast differentiation and promotes myogenesis in cachectic tumor-bearing c26 mice. [2021]

3. England pubmed.ncbi.nlm.nih.gov

A study to evaluate safety and tolerability of repeated doses of tirasemtiv in patients with amyotrophic lateral sclerosis. [2015]

4. England pubmed.ncbi.nlm.nih.gov

Newly discovered molecules associated with trimetazidine on improvement of skeletal muscle function in aging: evidence from myoblasts and mice. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Pharmaceutical Agents for Contractile-Metabolic Dysfunction After Volumetric Muscle Loss. [2023]