Tirzepatide Titration to Reduce Side Effects in Individuals With Obesity
ConditionObesity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorDasman Diabetes Institute
About this trial
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 criteria
Qualifiers
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
Disqualifiers
A self-reported change in body weight >5 kg (11 lbs) within 90 days before screening irrespective of medical records.
Treatment with any medication for the indication of obesity within the past 90 days before screening.
Previous or planned (during the trial period) obesity treatment with surgery or a weight-loss device. However, the following are allowed: (1) liposuction and/or abdominoplasty, if performed >1 year before screening; (2) lap banding, if the band has been removed >1 year before screening; (3) intragastric balloon, if the balloon has been removed >1 year before screening; or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed >1 year before screening.
Uncontrolled thyroid disease, defined as thyroid stimulating hormone >6.0 mIU/L or <0.4 mIU/L as measured by the central laboratory at screening.
Trial design
Treatments tested in this trial
- Tirzepatide (Per-label titration)
- Tirzepatide (Flexible titration)
Treatment groups
68 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Dasman Diabetes Institute
Lead sponsor
University of Ulster
Collaborator
Source ClinicalTrials.gov