Tirzepatide Titration to Reduce Side Effects in Individuals With Obesity

Study acronym: TiTRE
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
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Record History

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  1. Notable Primary endpoint(s) modified
    • Eligibility criteria expanded, about 63 words
    • Secondary endpoints: 33 to 34
    • Study description expanded, about 56 words
  2. Notable Recruitment opened
    • Secondary endpoints: 32 to 33
    v3
  3. Notable Primary endpoint(s) modifiedv2
  4. Study First Submitted
  • 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.
The goal of this clinical trial is to determine whether a flexible, symptom-guided titration strategy for tirzepatide can help adults with obesity without diabetes stay on treatment longer, while maintaining weight-loss effectiveness. The main questions it aims to answer are: * Does flexible, symptom-guided titration increase time on treatment (delay treatment discontinuation) compared with standard per-label titration over 76 weeks? * Does flexible titration reduce gastrointestinal side effects, such as nausea and vomiting, compared with standard titration? * Does flexible titration achieve weight loss comparable to standard titration? Researchers will compare standard per-label titration with a click-based, symptom-guided titration approach to assess differences in treatment persistence, tolerability, and effectiveness. Participants will: * Be randomly assigned to standard or flexible tirzepatide titration * Use a click-based dosing method that allows small dose increases based on tolerability (flexible group) * Attend study visits over 76 weeks for safety and outcome assessments This study addresses the lack of evidence for individualized titration strategies in obesity treatment and aims to improve tolerability, treatment persistence, and long-term treatment outcomes.
Trial Details
NCT Number NCT07574723
Lead Sponsor Dasman Diabetes Institute
Collaborators: University of Ulster
Conditions
(from sponsor)
Obesity
Related terms Obesity
Enrollment 68 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov