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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how tirzepatide, a medication approved for type 2 diabetes and obesity, affects muscle health in older adults. Researchers aim to determine if weight loss from this drug leads to muscle loss and impacts strength or daily activities. The study specifically seeks men and postmenopausal women aged 50 or older with a BMI of 30 or above, who do not currently have type 2 diabetes. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

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.

Is there any evidence suggesting that tirzepatide is likely to be safe for humans?

Research shows that tirzepatide is an FDA-approved treatment for managing type 2 diabetes and obesity. Studies have found it can lead to significant weight loss and improved health indicators. However, some safety points require consideration.

In everyday use, some individuals taking tirzepatide have experienced issues with incorrect dosing, reactions at the injection site, and gastrointestinal problems like upset stomach. While it helps reduce body fat, tirzepatide might also cause muscle loss, which is particularly important for older adults to consider.

Consulting a doctor about any concerns is crucial, especially when considering participation in a clinical trial. A doctor can help explain the benefits and risks based on personal health needs. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about tirzepatide for muscle health because it offers a novel approach compared to existing treatments. Unlike traditional options, which may not directly target muscle health, tirzepatide is a dual-action peptide that activates both GLP-1 and GIP receptors. This unique mechanism of action could potentially enhance muscle mass and function more effectively. Additionally, tirzepatide is self-administered once a week via a simple subcutaneous injection, providing convenience and ease of use for patients.

What is the effectiveness track record for tirzepatide in treating obesity and type 2 diabetes?

Studies have shown that tirzepatide, the treatment under investigation in this trial, effectively reduces body weight and manages type 2 diabetes. It targets specific receptors in the body to control blood sugar and reduce appetite. Research indicates that while tirzepatide leads to significant weight loss, some of this loss may include muscle. For example, one study found that 72-75% of the weight lost with tirzepatide was fat, suggesting some muscle loss could occur. This might affect muscle strength and function, particularly in older adults. Overall, tirzepatide has proven effective for weight loss and diabetes control, but its full impact on muscle health in older adults remains under study. ^{1 2 3 6 7}

Who Is on the Research Team?

Elena Volpi, MD, PhD

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

Shreya Rao, MD, MPH

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

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

Untreated HbA1c <6.5% at baseline

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12394919/

Effects of Tirzepatide on Skeletal Muscle Mass in Adults

This table summarizes outcomes from the included trials on changes in lean mass and muscle composition with tirzepatide, using DXA (SURMOUNT-1) and MRI ( ...

2.

thelancet.com

thelancet.com/journals/landia/article/PIIS2213-8587(25)00027-0/fulltext

Tirzepatide and muscle composition changes in people ...

Tirzepatide has been associated with significant reductions in body weight in type 2 diabetes trials and a beneficial effect on body fat distribution.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2376060524001378

Case Report Skeletal Muscle Mass and Body Weight Fall ...

Treatment with tirzepatide resulted in a reduction of weight by 28.7 lbs, a decrease in body mass index to 26.8 kg/m2, and normalization of A1c (5.3%).

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06811324

NCT06811324 | Effects of Tirzepatide on Muscle and ...

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, ...

5.

dom-pubs.onlinelibrary.wiley.com

dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.16275

Body composition changes during weight reduction with ...

The tirzepatide 5, 10 and 15 mg doses resulted in 75%, 72% and 75% body weight lost as fat mass, respectively, consistent with overall findings ...

6.

mdpi.com

mdpi.com/2227-9032/13/18/2259

Real-World Safety Concerns of Tirzepatide

Conclusions: Tirzepatide is associated with significant dosing errors, injection-site reactions, and gastrointestinal AEs in real-world use. The rising trend in ...

7.

mayoclinic.org

mayoclinic.org/drugs-supplements/tirzepatide-subcutaneous-route/description/drg-20534045

Tirzepatide (subcutaneous route) - Side effects & dosage

Safety and efficacy have not been established. Geriatric. Appropriate studies ... Check with your doctor right away if you have a bloody urine, decreased urine ...