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Tirzepatide Titration to Reduce Side Effects in Individuals With Obesity

NCT07574723 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Tirzepatide (Flexible titration)

Tirzepatide is administered by subcutaneous injection once weekly. Dose escalation follows a flexible titration schedule as defined in the study protocol.

DRUG

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

Sponsors & Collaborators

  • University of Ulster

    collaborator OTHER

  • Dasman Diabetes Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-15
Primary Completion
2029-05-15
Completion
2029-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07574723 on ClinicalTrials.gov