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 type | Interventional |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 68 (estimated) |
| Sponsor | Dasman Diabetes Institute Academic / other |
| Locations | 1 site (Kuwait City) |
| Status | Recruiting |
| Started | May 15, 2026 |
| Main results expected | May 15, 2029 |
| Study ends | December 31, 2029 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT07574723 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
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Ocular Changes in People Using Tirzepatide or Semaglutide
This study checks whether eye structure and blood vessels change in adults with obesity who are taking semaglutide or tirzepatide as part of routine care.
-
Whole-Body Vibration Training in Women With Obesity With and Without Type 2 Diabetes
This study tests whether eight weeks of supervised whole-body vibration training changes ankle muscle activity and walking performance in women with obesity, comparing those with and without type 2 diabetes.
-
Berobenatide for knee pain in adults who are overweight or with obesity
This study tests berobenatide vs. placebo to see if it reduces knee pain and improves function while helping with weight in adults with knee osteoarthritis and overweight/obesity.
-
Weekly berobenatide for knee osteoarthritis in adults who are overweight or obese
This study tests whether weekly berobenatide helps reduce knee pain and improve function, while also affecting body weight, in adults with knee osteoarthritis who are overweight or obese (with or without type 2 diabetes).
-
Maridebart cafraglutide in people who switched from weekly GLP-1 receptor agonists
This study tests how much maridebart cafraglutide appears in the blood after people with overweight or obesity switch from weekly GLP-1 receptor agonists.
-
EloraTZP for weight loss in adults with overweight/obesity and type 2 diabetes
This trial tests whether a coformulation of eloralintide and tirzepatide helps people with obesity or overweight and type 2 diabetes lose weight compared with tirzepatide alone.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.