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A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes

CompletedPhase 3

Sponsor: Eli Lilly and Company

Conditions: Obesity, Overweight, Type 2 Diabetes

Interventions: Orforglipron, Placebo

Countries: United States, Argentina, Australia, Brazil, China, Czechia, Germany, Greece

This study will investigate the safety and efficacy of once daily oral treatment with orforglipron compared with placebo on body weight in adult participants with obesity or overweight and type 2 diabetes. The study will last about 77 weeks and may include up to 22 visits.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Have a body mass index (BMI) ≥27.0 kilogram/square meter (kg/m²).
* Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
* Have a diagnosis of Type 2 Diabetes (T2D), with HbA1c ≥7% (≥53 mmol/mol) to ≤10% (86 mmol/mol) and are on stable treatment for T2D for at least 90 days prior to screening, consisting of:

  * either diet/exercise alone or
  * up to 3 oral antihyperglycemic medications (excluding dipeptidyl peptidase IV inhibitors (DPP-4i) or glucagon-like peptide-1 (GLP-1) receptor agonists (RA).

Exclusion Criteria:

* Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D.
* Have a self-reported change in body weight \>5 kg (11 pounds) within 90 days prior to screening.
* Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (for example, laser photocoagulation or intravitreal injections of anti-vascular endothelial growth factor inhibitors).
* Have family (first-degree relative) or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia 2 (MEN2) syndrome.
* Have had a history of chronic or acute pancreatitis.

Locations (136)

Pelham, Alabama, United States
Tucson, Arizona, United States
Yuma, Arizona, United States
Escondido, California, United States
Huntington Park, California, United States
Los Angeles, California, United States
Montclair, California, United States
Tustin, California, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Margate, Florida, United States
New Port Richey, Florida, United States
Lawrenceville, Georgia, United States
Roswell, Georgia, United States
Woodstock, Georgia, United States
Honolulu, Hawaii, United States
Meridian, Idaho, United States
West Des Moines, Iowa, United States
Baltimore, Maryland, United States
Troy, Michigan, United States
City of Saint Peters, Missouri, United States
Las Vegas, Nevada, United States
Albuquerque, New Mexico, United States
Albany, New York, United States
Albany, New York, United States
Long Island City, New York, United States
Raleigh, North Carolina, United States
Portland, Oregon, United States
Knoxville, Tennessee, United States
Dallas, Texas, United States
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