GLP-1s to Enhance Lasting Optimal Weight
Part of paid clinical trials in Winston-Salem, North Carolina.
- Sponsor
- Wake Forest University Health Sciences
- Study ID
- NCT06861439
- Phase
- PHASE4
- Status
- Active Not Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 65 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Tirzepatide — DRUGTirzepatide 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.
Study Details
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.
Key Dates
- Start date
- Jul 7, 2025
- Status verified
- Oct 2025
- Primary completion
- Sep 30, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 40 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: TirzepatideTirzepatide injection once weekly for 9 months
Primary Outcome Measure
Change in total body lean mass [ Time Frame: Baseline to Month 9 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | - |
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