A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program

Completed · Phase 3 · Has a placebo group

Conditions studied: Obesity, Overweight

In brief

This is a study of tirzepatide in participants with obesity. The purpose of this study is to learn more about how tirzepatide maintains body weight or adds to weight loss after an intensive lifestyle modification program. The study will last about 2 years (29 visits).

Key facts

Study ID

NCT04657016

Run by

Eli Lilly and Company

People needed

579

Starts

2021-03-29

Expected to finish

2023-05-12

Last updated by the study team

2024-05-16

Who can join

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

You may qualify if…

• Have a body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 and previously diagnosed with at least 1 of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or 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

• National Research Institute - Wilshire — Los Angeles, California, United States
• Catalina Research Institute, LLC — Montclair, California, United States
• National Research Institute (NRI) - Santa Ana — Santa Ana, California, United States
• Encompass Clinical Research — Spring Valley, California, United States
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States
• Chase Medical Research, LLC — Waterbury, Connecticut, United States
• Clinical Research of South Florida — Coral Gables, Florida, United States
• New Horizon Research Center — Miami, Florida, United States
• Precision Clinical Research — Sunrise, Florida, United States
• Clinical Research of West Florida — Tampa, Florida, United States
• Metabolic Research Institute, Inc. — West Palm Beach, Florida, United States
• Elite Clinical Trials — Blackfoot, Idaho, United States
• Solaris Clinical Research — Meridian, Idaho, United States
• Elite Clinical Trials — Rexburg, Idaho, United States
• Evanston Premier Healthcare Research LLC — Evanston, Illinois, United States
• American Health Network of IN, LLC — Avon, Indiana, United States
• American Health Network of IN, LLC — Franklin, Indiana, United States
• American Health Network of IN, LLC — Muncie, Indiana, United States
• Cotton O'Neil Mulvane — Topeka, Kansas, United States
• Tandem Clinical Research,LLC — Marrero, Louisiana, United States
• The National Diabetes & Obesity Research Institute — Biloxi, Mississippi, United States
• Clinvest Research LLC — Springfield, Missouri, United States
• Quality Clinical Research — Omaha, Nebraska, United States
• Palm Research Center Sunset — Las Vegas, Nevada, United States
• National Research Institute - Huntington Park — Huntington Park, California, United States

Full record on ClinicalTrials.gov

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