A Study of Tirzepatide (LY3298176) in Participants With Obesity Disease

• Status: Recruiting
• Trial end date: 2023-08-14
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: LY3298176; Tirzepatide

Criteria

Inclusion Criteria:

• Have a BMI of greater than or equal to ≥27 kg/m² and2 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.