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A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities

Active Not RecruitingPhase 3

Sponsor: Eli Lilly and Company

Conditions: Obesity, Overweight, Overweight or Obesity

Interventions: Orforglipron, Placebo

Countries: United States, Brazil, China, India, Japan, Puerto Rico, Slovakia, South Korea

This study will investigate the efficacy and safety of once daily oral orforglipron in adult participants with obesity or overweight with weight-related comorbidities. The study has two phases: a main phase and an extension phase. The main phase of the study lasted 72 weeks. Participants with prediabetes will continue in the extension for another 2 years.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Have a BMI

  * ≥30.0 kilogram/square meter (kg/m²),
  * ≥27.0 kg/m² and presence of at least 1 of the following weight-related comorbidities (treated or untreated) at screening:

    * Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure).
* Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.

Exclusion Criteria:

* Have Type 1 diabetes, Type 2 diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma
* Have a self-reported change in body weight \>5 kg (11 pounds) within 90 days prior to screening.
* Have family (first-degree relative) or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia (MEN)2 syndrome.
* Have had a history of chronic or acute pancreatitis.

Locations (138)

Chandler, Arizona, United States
Sun City West, Arizona, United States
Concord, California, United States
Escondido, California, United States
Greenbrae, California, United States
Huntington Park, California, United States
Los Angeles, California, United States
Montclair, California, United States
San Ramon, California, United States
Tustin, California, United States
Aurora, Colorado, United States
Miami, Florida, United States
Miramar, Florida, United States
Ocala, Florida, United States
Tampa, Florida, United States
Winter Park, Florida, United States
Lawrenceville, Georgia, United States
Macon, Georgia, United States
Union City, Georgia, United States
Honolulu, Hawaii, United States
Blackfoot, Idaho, United States
Topeka, Kansas, United States
Topeka, Kansas, United States
Baton Rouge, Louisiana, United States
Lake Charles, Louisiana, United States
Hyattsville, Maryland, United States
Rockville, Maryland, United States
Troy, Michigan, United States
Ridgeland, Mississippi, United States
Las Vegas, Nevada, United States
+ 108 more on CT.gov