A Study of LY3298176 (Tirzepatide) For the Maintenance of Body Weight Reduction in Participants W… (NCT06047548) | Clinical Trial Compass
CompletedPhase 3
A Study of LY3298176 (Tirzepatide) For the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
United States441 participantsStarted 2023-09-20
Plain-language summary
The main purpose of this study is to evaluate the efficacy and safety of tirzepatide for the maintenance of body weight reduction.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Have a Body Mass Index (BMI) of ≥30 kilogram/square meter (kg/m²) or ≥27 kg/m² and previously diagnosed with at least 1 of the following weight related comorbidities:
* Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
* Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight (BW)
Exclusion Criteria:
* Have Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D), a history of ketoacidosis, or hyperosmolar state or coma.
* Have a self-reported change in BW\>5 kilogram (kg) within 3 months prior to screening
* Have a prior or planned surgical treatment for obesity, excluding liposuction or abdominoplasty if performed \>1 year prior to screening.
* Have a history of chronic or acute pancreatitis
* Have any of the following cardiovascular conditions within 3 months prior to week 0.
* Acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, and hospitalization due to congestive heart failure (CHF)
* family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
* History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
* Any lifetime history of a suicide attempt
What they're measuring
1
Percent Maintenance of Body Weight (BW) Reduction Achieved during the 60-Week Weight Loss Period