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Tirzepatide Titration to Reduce Side Effects (TiTRE) in Individuals With Obesity

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Adults aged 18 years and older

• A diagnosis of obesity (BMI ≥ 27 kg/m2) at screening with self-reported unsuccessful dietary efforts to lose weight.

• No diagnosis of diabetes mellites.

• Able to understand and sign the consent form

• Able to undergo DEXA scan.

Locations
Other Locations
Kuwait
Dasman Diabetes Institute
RECRUITING
Kuwait City
Time Frame
Start Date: 2026-05-15
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 68
Treatments
Active_comparator: Per-label arm (Control)
Participants receive tirzepatide with dose escalation according to the manufacturer's prescribing information.
Experimental: Flexible titration arm (Intervention)
Participants receive tirzepatide administered with a flexible dose escalation schedule.
Related Therapeutic Areas
Sponsors
Leads: Dasman Diabetes Institute
Collaborators: University of Ulster

This content was sourced from clinicaltrials.gov