๐ฌIn plain words
What the trial is, and whether it could suit you
The goal of this clinical trial is to determine whether a flexible, symptom-guided titration strategy for tirzepatide can help adults with obesity without diabetes stay on treatment longer, while maintaining weight-loss effectiveness. The main questions it aims to answer are:
* Does flexible, symptom-guided titration increase time on treatment (delay treatment discontinuation) compared with standard per-label titration over 76 weeks?
* Does flexible titration reduce gastrointestinal side effects, such as nausea and vomiting, compared with standard titration?
* 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 treatment persistence, tolerability, and effectiveness.
Participants will:
* Be randomly assigned to standard or flexi
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
1. Adults aged 18 years and older
2. A diagnosis of obesity (BMI โฅ 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 โฅ15 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.