Efficacy and Safety of Once Weekly Tirzepatide in Participants with Obesity Disease: A Randomized, Double Blind, Placebo Controlled Trial (SURMOUNT-J) (I8F-JE-GPHZ)

Eli Lilly Japan K.K.0 个研究点目标入组 261 人开始时间: 2021年5月10日最近更新: 2025年5月7日

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•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.

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