Prevalence of Cardiometabolic Diseases Among Racial and Ethnic Subgroups in Adults - Behavioral Risk Factor Surveillance System, United States, 2013-2021.
Alain K Koyama, Kai McKeever Bullard, Fang Xu...
https://pubmed.ncbi.nlm.nih.gov/38271277/Actively Recruiting
Led by The University of Texas Health Science Center at San Antonio · Updated on 2026-04-15
20
Participants Needed
1
Research Sites
8 weeks
Total Duration
This research aims to study the effects of tirzepatide, a new medication approved for type 2 diabetes and obesity, on muscle mass and function in older adults with obesity. The study focuses on people aged 50 and older, especially since weight loss from tirzepatide might include loss of muscle, which can cause weakness and frailty. The study is a pilot, single-arm, open-label trial conducted in South Texas, where obesity and related diseases are common among aging adults. Participants will self-administer tirzepatide once a week by injection, starting at 2.5 mg with dose increases monthly up to 10 mg or the highest tolerated dose. The treatment period lasts for 6 months. The trial evaluates how tirzepatide affects muscle mass, strength, and vascular health during this time. During the study, participants will undergo assessments of muscle mass, muscle strength, and lower extremity function at the start and after 6 months of treatment. Researchers will monitor changes in these outcomes to understand the impact of tirzepatide on muscle and vascular health. Participants are expected to comply with fasting and other study procedures, and the total duration of involvement is 6 months.
CONDITIONS
Effects of Tirzepatide on Muscle and Vascular Health in Obese Older Adults
S
Suha Soni
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The University of Texas Health Science Center at San Antonio
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Tirzepatide (study dose-escalation group) | Lifestyle Intervention (Diet and Exercise) |
|---|---|---|
| What it is | Tirzepatide, a once-weekly dual GIP/GLP-1 receptor agonist, given as a subcutaneous injection with dose escalation up to 10 mg/weekly or highest tolerated dose, as studied in this trial. | A structured, supervised multi-component program targeting dietary changes and physical activity, delivered as guideline-recommended lifestyle intervention for older adults with obesity or sarcopenia. |
| Primary use | Investigational therapy being assessed for effects on muscle mass, strength, and lower extremity function in older adults with obesity but without diabetes. | Current standard-care approach for weight reduction and maintenance of muscle health in older adults, aiming to reduce obesity-related risk and functional decline. |
| How it is given or performed | Administered by subcutaneous injection once weekly, beginning at 2.5 mg with monthly dose increases up to 10 mg/weekly or the maximum tolerated dose, as per the protocol. | Supervised by healthcare or exercise professionals, typically involving individualized nutrition plans and structured exercise routines, often at least 150 minutes per week of moderate activity. |
| Evidence status | Tirzepatide demonstrates strong weight loss and some improvements in muscle composition and function in overweight or obese adults, but effects in older adults without diabetes—especially on muscle mass and physical function—require further confirmation and are the subject of this ongoing trial. | Diet and exercise interventions reliably yield modest weight loss, prevention or reversal of sarcopenia, and improvements in muscle strength and physical performance among older adults. |
| Important limitations | Risks include gastrointestinal symptoms, potential for adverse events seen with GLP-1 receptor agonists, and unknown longer-term effects on muscle quality in this population. The study is a single-arm, small sample and cannot directly compare against current-care outcomes. | Weight loss and muscle health gains with lifestyle interventions alone are often modest, require sustained long-term adherence, and effectiveness varies among older adults with comorbidities. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive weekly self-administered injections of Tirzepatide with dose escalation monthly up to a target dose or maximum tolerated dose.
Weekly visits for 6 months
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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https://pubmed.ncbi.nlm.nih.gov/35977298/The University of Texas Health Science Center at San Antonio
Lead Sponsor