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Effects of Tirzepatide on Muscle and Vascular Health in Obese Older Adults

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Minor Primary completion pushed from Feb 1, 2027 to Apr 1, 2027
    • Start date changed from estimate of Feb 15, 2026 to Apr 1, 2026
    v5
  2. Notable Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Jan 1, 2026 to Feb 1, 2027
    • Start date: Sep 15, 2025 to Feb 15, 2026
    • Study completion date: Jun 1, 2026 to Jun 1, 2027
    • Site details revised
  3. Notable Start date: Jul 30, 2025 to Sep 15, 2025v3 Show 4 more changesShow less
    • Publications: 16 to 13
    • Eligibility criteria shortened, about 3 words
    • Study description shortened, about 1 word
    • Study title shortened, about 1 word
  4. Notable Start date: Mar 1, 2025 to Jul 30, 2025v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Obesity and type 2 diabetes mellitus (T2DM) represent major public health concerns in the aging 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 among older adults has been on the rise since FDA approval was issued, however the effects of tirzepatide use on functional outcomes in older 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 adults, and if changes in muscle mass are linked to changes in functional status over the same time period.
Trial Details
NCT Number NCT06811324
Lead Sponsor The University of Texas Health Science Center at San Antonio
Conditions
(from sponsor)
Obesity Prevention, Sarcopenia in Elderly, Cardiovascular Function, GLP - 1, Weight Loss
Related terms Obesity, Sarcopenia, Weight Loss
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov