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Tirzepatide Titration to Reduce Side Effects in Individuals With Obesity
Sponsor: Dasman Diabetes Institute
Summary
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.
Official title: Tirzepatide Titration to Reduce Side Effects (TiTRE) in Individuals With Obesity
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
68
Start Date
2026-05-15
Completion Date
2029-12-31
Last Updated
2026-10-20
Healthy Volunteers
No
Conditions
Interventions
Tirzepatide (Per-label titration)
Tirzepatide is administered by subcutaneous injection once weekly. Dose escalation follows the manufacturer's prescribing information, with advancement through labeled dose levels at prespecified intervals to the assigned maintenance dose
Tirzepatide (Flexible titration)
Tirzepatide is administered by subcutaneous injection once weekly. Dose escalation follows a flexible titration schedule as defined in the study protocol.
Locations (1)
Dasman Diabetes Institute
Kuwait City, Kuwait