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

17506

The main purpose of this study is to learn more about tirzepatide in participants with obesity disease. The study will also measure how Tirzepatide affects body weight with a low-calorie diet and increased physical activity. The study will last around 72 Weeks.

2021-05-10

2023-06-24

2023-06-24

Completed

Early phase I

267

Inclusion Criteria: * 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. Exclusion Criteria: * 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 (μIU/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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2023-08-08