NCT06861439

GLP-1s to Enhance Lasting Optimal Weight

Effects of Tirzepatide on Fat-Free Mass, Bone and Physical Function in Older Adults - a Pilot Study

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to examine how tirzepatide affects body composition, bone health, and physical performance in older adults over a nine-month period. Participants will take tirzepatide weekly, have clinic visits every 4 weeks, meet study doctor and registered dietitian every 4 weeks in person or video conference, attend group intervention sessions twice a month via video conference, weigh daily with a study-provided smart scale, keep a record of all foods and beverages consumed, and use a study-provided activity tracker to keep track of daily step counts.

Detailed description

This study will enroll 40 older adults with obesity (or overweight with a weight-related comorbidity) in a 9-month pilot to examine the effects of tirzepatide on body composition, bone health, and physical performance. All participants will receive tirzepatide, 5 mg per week and counseling sessions (group and individual) on diet quality and physical activity as well as behavioral strategies to facilitate dietary and physical activity changes. Participants will be expected to weigh themselves daily on a smart scale, record their food and beverage consumption, and keep track of daily step counts over the 9-month intervention period. Body composition, bone health, and physical performance will be measured at baseline prior to intervention and approximately nine months later. This data will be used to examine the effects of tirzepatide on total and appendicular lean and total fat mass measured by DXA; hip and spine bone mineral density measured by DXA; and leg strength and physical performance (expanded Short Physical Performance Battery, 400-m walk).

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Tirzepatide	Tirzepatide will be initiated at a dose of 2.5 mg weekly and increased as tolerated to 5 mg weekly at four weeks for the remainder of the 9-month intervention period. Participants who are unable to tolerate the 5 mg dose will be decreased to the 2.5 mg dose.

Timeline

• Start date: 2025-07-07
• Primary completion: 2026-09-30
• Completion: 2026-12-31
• First posted: 2025-03-06
• Last updated: 2025-10-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study