Clinical trial Recruiting at 1 site Interventional Ages 18 to 100

Tirzepatide Titration to Reduce Side Effects in Obesity

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

Run by Dasman Diabetes Institute · NCT07574723 · Data updated 2026-11-12

This trial tests whether a flexible, symptom-guided tirzepatide titration helps adults with obesity stay on treatment longer while still losing weight.

Quick facts

Study typeInterventional
Ages18 Years to 100 Years
SexAll
Enrollment68 (estimated)
SponsorDasman Diabetes Institute
Academic / other
Locations1 site (Kuwait City)
StatusRecruiting
StartedMay 15, 2026
Main results expectedMay 15, 2029
Study endsDecember 31, 2029
Registry record updatedOctober 20, 2026
Trial IDNCT07574723 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18 and older with obesity (BMI ≥ 27 kg/m2) without diabetes who have attempted diet but not achieved sufficient weight loss.

Probably not a fit

Individuals with diabetes, recent obesity treatments, or medications likely to cause weight changes or GI intolerance may not benefit from this approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized study compares standard per-label tirzepatide titration to a flexible, click-based titration guided by gastrointestinal symptoms over 76 weeks. Researchers will measure time on treatment, tolerability (nausea and vomiting), and weight loss. All participants will have regular visits to assess persistence, weight change, safety, and adherence. The goal is to see if tailoring dose increases to individual tolerance can improve persistence without sacrificing effectiveness.

Why it matters

Potential benefit: If successful, patients may experience longer treatment duration with fewer gastrointestinal side effects and meaningful weight loss.

How similar studies have gone: Previous studies in obesity have explored personalized dosing, but evidence for flexible titration strategies remains limited and the approach is relatively novel here.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Adults aged 18 years and older
2. A diagnosis of obesity (BMI ≥ 27 kg/m2) at screening with self-reported unsuccessful dietary efforts to lose weight.
3. No diagnosis of diabetes mellites.
4. Able to understand and sign the consent form
5. Able to undergo DEXA scan.

Exclusion Criteria:

* 1\. History of type 1 or type 2 diabetes mellites. 2. Obesity-related:

  * 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.
  * Current use, or use within 90 days before screening, of medications with the potential to increase body weight (e.g., systemic glucocorticosteroids, antipsychotics, antidepressants, and antiepileptics) or to reduce body weight (e.g., diuretics).
  * 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.

    3\. Mental health:
  * History of major depressive disorder within 2 years before screening.
  * Diagnosis of other severe psychiatric disorder (e.g. schizophrenia, bipolar disorder).
  * A Patient Health Questionnaire-9 score of ≥15 at screening.
  * A lifetime history of a suicidal attempt.
  * Suicidal behavior within 30 days before screening. 4. General safety:
  * Use of non-herbal Chinese medicine or other non-herbal local medicine with unknown/unspecified content within 90 days before screening.
  * Presence of acute pancreatitis within the past 180 days prior to the day of screening.
  * History or presence of chronic pancreatitis.
  * Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
  * Renal impairment measured as estimated glomerular filtration rate value of \<15 mL/min/1.73 m2 as defined by KDIGO 2012 by the central laboratory at screening.
  * History of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed.
  * Any of the following: myocardial infarction, stroke, hospitalization for unstable angina, or transient ischemic attack within the past 60 days prior to screening.
  * Subject presently classified as being in New York Heart Association Class IV.
  * Surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the investigator.
  * Known or suspected abuse of alcohol or recreational drugs.
  * Known or suspected hypersensitivity to trial product(s) or related products.
  * Previous participation in this trial. Participation is defined as signed informed consent.
  * Participation in another clinical trial within 90 days before screening.
  * Female who is pregnant, breast-feeding, or intends to become pregnant, or is of child-bearing potential and not using a highly effective contraceptive method.
  * Any disorder, unwillingness, or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the subject's safety or compliance with the protocol.

Where it's running

  • Dasman Diabetes Institute
    Kuwait City, Kuwait
    Recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.