A Study of Tirzepatide (LY3298176) in Participants With Obesity Disease (SURMOUNT-J)
- Conditions
- Obesity Disease
- Registration Number
- JPRN-jRCT2031210044
- Lead Sponsor
- Masaki Takeshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 261
Have a BMI of greater than or equal to >=27 kg/m2 and less than <35 kg/m2 with at least 2 obesity-related health problems or >=35 kg/m2 with at least 1 obesity-related health problems.
- Health problems are IGT, hyperlipidemia, or NAFLD.
- Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
- Have diabetes.
- Acute or chronic liver disease other than NAFLD.
- Have a self-reported change in body weight >5 kg within 3 months prior to screening.
- Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months.
- Have renal impairment measured as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, calculated by Japanese Society of Nephrology coefficient-modified Chronic Kidney Disease-Epidemiology equation during screening.
- Have a known clinically significant gastric emptying abnormality.
- Have had a history of chronic or acute pancreatitis.
- Have thyroid-stimulating hormone outside of the range of 0.4 to 6.0 micro units per milliliter (micro IU/mL) at screening.
- Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity.
- Have a history of significant active or unstable major depressive disorder or other severe psychiatric disorder within the last 2 years.
- Have a cardiovascular condition within 3 months prior to randomization
- Have a family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome type 2.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Percentage of Participants Who Achieve >=5% Body Weight Reduction<br>2. Percent Change in Body Weight
- Secondary Outcome Measures
Name Time Method