Clinical Trial

Tirzepatide Titration to Reduce Side Effects in Individuals With Obesity

Study acronym: TiTRE
Recruiting
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Summary
The goal of this clinical trial is to determine whether a flexible, symptom-guided titration strategy for tirzepatide can reduce gastrointestinal side effects while maintaining weight-loss effectiveness in adults with obesity without diabetes. The main questions it aims to answer are: 1. Does flexible, symptom-guided titration reduce nausea and vomiting compared with standard per-label titration? 2. 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 tolerability and treatment 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, adherence, and long-term treatment outcomes.
Protocol Amendment History 2 changes
critical Recruitment opened 2026-07-09
critical Primary endpoint(s) modified 2026-06-04
Trial Details
NCT Number NCT07574723
Lead Sponsor Dasman Diabetes Institute
Collaborators: University of Ulster
Conditions Obesity
Enrollment 68 participants
Start Date 2026-05-15
Primary Completion 2029-05-15 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-08