Overview
A Study of Tirzepatide (LY3298176) in Participants With Obesity Disease
Status:
Recruiting
Recruiting
Trial end date:
2023-08-14
2023-08-14
Target enrollment:
0
0
Participant gender:
All
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 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Eli Lilly and CompanyTreatments:
LY3298176
Tirzepatide
Criteria
Inclusion Criteria:- Have a BMI of greater than or equal to ≥27 kg/m² and
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.