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

Masaki Takeshi0 个研究点目标入组 261 人开始时间: 2021年4月21日最近更新: 2023年10月17日

试验速览

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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.

发起方

Masaki Takeshi