A Study of Tirzepatide (LY3298176) in Participants With Obesity Disease (SURMOUNT-J) (I8F-JE-GPHZ)

Completed

• Conditions: Obesity Disease

• Registration Number: jRCT2031210044
• Lead Sponsor: Eli Lilly Japan K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-21
• Study Start: 2021-05-10
• Last Update Posted: 2025-05-07

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 261

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 (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: parallel assignment