Health Trials

Tirzepatide Titration to Reduce Side Effects in Individuals With Obesity

ConditionObesity
Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Tirzepatide (Per-label titration)

    Drug

    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)

    Drug

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

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: Per-label arm (Control)Active comparator 1 intervention
Group B: Flexible titration arm (Intervention)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Vomiting episodes per patient assessed using the Modified Index of Nausea, Vomiting, and Retching (M-INVR)

Vomiting episodes per patient will be assessed using the validated Modified Index of Nausea, Vomiting, and Retching (M-INVR). The vomiting component is administered weekly, with scores ranging from 0 (no vomiting) to 4 (severe or frequent vomiting), where higher scores indicate worse outcomes. Vomiting burden will be summarized as: * Weekly vomiting severity scores based on M-INVR, and * An exposure-adjusted rate of vomiting episodes (episodes per patient-week), calculated by dividing the total number of reported vomiting episodes by the total duration of follow-up for each participant. This approach accounts for differences in treatment duration and follow-up time.

Time frame
From enrollment (at baseline) to the end of treatment at 76 weeks.

Secondary outcomes

1

Incidence, frequency, and duration of vomiting assessed using the MASCC Antiemesis Tool - Modified Index of Nausea and Vomiting (M-INVR)

Vomiting is assessed weekly using the MASCC Antiemesis Tool - Modified Index of Nausea and Vomiting (M-INVR), a validated patient-reported outcome measure. The vomiting subscale score is calculated as the sum of relevant vomiting items, with scores ranging from 0 to 16, where higher scores indicate greater incidence, frequency, and duration of vomiting (worse outcome).

Time frame
Baseline to Week 76
2

Change in body weight

Absolute and percentage change in body weight from baseline.

Time frame
Baseline to Week 76
3

Proportion of participants remaining on active study medication

Number of participants continuing to receive active study medication at the end of the trial.

Time frame
Week 76
4

Change in glycated hemoglobin (HbA1c)

Change in HbA1c from baseline.

Time frame
Baseline to Week 76

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dasman Diabetes Institute

Lead sponsor

University of Ulster

Collaborator

Source ClinicalTrials.gov
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