New study aims to make Weight-Loss drug easier to tolerate
NCT ID NCT07574723
First seen Jun 27, 2026 · Last updated Jul 09, 2026 · Updated 2 times
Summary
This study tests whether a flexible, symptom-guided dosing plan for tirzepatide can reduce nausea and vomiting compared to the standard dosing plan in adults with obesity who do not have diabetes. Participants will be randomly assigned to one of two dosing strategies and followed for 76 weeks. The goal is to improve tolerability and help people stay on treatment longer.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 68 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Dasman Diabetes Institute
RECRUITINGKuwait City, 15462, Kuwait
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