A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight

Completed · Phase 3 · Has a placebo group

Conditions studied: Overweight, Obesity

In brief

This is a study of tirzepatide in participants with overweight and obesity. The main purpose is to learn more about how tirzepatide affects body weight. The study has two phases: A main phase and an extension phase. The main phase of the study will last 72 weeks. Participants with prediabetes will continue in the extension for another 2 years.

Key facts

Study ID

NCT04184622

Run by

Eli Lilly and Company

People needed

2539

Starts

2019-12-04

Expected to finish

2024-07-06

Last updated by the study team

2025-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≥27 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
• History of at least one unsuccessful dietary effort to lose body weight

You may not qualify if…

• Diabetes mellitus
• Change in body weight greater than 5 kg within 3 months prior to starting study
• Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
• History of pancreatitis
• Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
• History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
• Any lifetime history of a suicide attempt

Where it is running

• Perseverance Research Center — Scottsdale, Arizona, United States
• John Muir Physician Network Clinical Research Center — Concord, California, United States
• Valley Research — Fresno, California, United States
• National Research Institute - Wilshire — Los Angeles, California, United States
• Catalina Research Institute, LLC — Montclair, California, United States
• Encompass Clinical Research — Spring Valley, California, United States
• University Clinical Investigators, Inc. — Tustin, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Chase Medical Research, LLC — Waterbury, Connecticut, United States
• Suncoast Research Group — Miami, Florida, United States
• New Horizon Research Center — Miami, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Oviedo Medical Research — Oviedo, Florida, United States
• ForCare Clinical Research — Tampa, Florida, United States
• Center for Advanced Research & Education — Gainesville, Georgia, United States
• Herman Clinical Research — Suwanee, Georgia, United States
• SKY Integrative Medical Center/SKYCRNG — Union City, Georgia, United States
• East-West Medical Research Institute — Honolulu, Hawaii, United States
• Midwest Institute for Clinical Research — Indianapolis, Indiana, United States
• Iowa Diabetes and Endocrinology Research Center — West Des Moines, Iowa, United States
• Cotton O'Neil Diabetes & Endocrinology — Topeka, Kansas, United States
• L-MARC Research Center — Louisville, Kentucky, United States
• NECCR PrimaCare Research — Fall River, Massachusetts, United States
• ActivMed Practices and Research — Methuen, Massachusetts, United States
• Cahaba Research — Pelham, Alabama, United States

Full record on ClinicalTrials.gov

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