Status:
COMPLETED
A Study of Tirzepatide (LY3298176) in Participants With Obesity Disease
Lead Sponsor:
Eli Lilly and Company
Conditions:
Obesity
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief 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 incr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2023
Estimated Enrollment :
267 Patients enrolled
Trial Details
Trial ID
NCT04844918
Start Date
May 10 2021
End Date
June 24 2023
Last Update
July 16 2024
Active Locations (18)
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1
Kohnodai Hospital, National Center for Global Health and Medicine
Ichikawa, Chiba, Japan, 272-8516
2
Saiseikai Matsuyama Hospital
Matsuyama, Ehime, Japan, 791-8026
3
Takai Internal Medicine Clinic
Kamakura-shi, Kanagawa, Japan, 247-0056
4
Saiseikai Yokohamashi Tobu Hospital
Yokohama, Kanagawa, Japan, 2308765