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A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone

NCT05971940

CompletedPhase 3

Sponsor: Eli Lilly and Company

Conditions: Type 2 Diabetes

Interventions: Orforglipron, Placebo

Countries: United States, China, India, Japan, Mexico, Puerto Rico

The main purpose of this study is to determine safety and efficacy of orforglipron compared with placebo in adult participants with type 2 diabetes and inadequate glycemic control with diet and exercise alone. The study will last approximately 54 weeks.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Have Type 2 Diabetes
* Have HbA1c ≥7.0% (53 mmol/mol) to ≤9.5% (80 mmol/mol) despite diet and exercise treatment, as determined by the central laboratory at screening.
* Are naïve to insulin therapy except for gestational diabetes or ≤14 days use for acute treatment and have not used any oral or injectable antihyperglycemic medications during the 90 days preceding screening or between screening and randomization.
* Are of stable weight (±5%) for at least 90 days prior to screening and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight other than the lifestyle and/or dietary measures for diabetes treatment.
* Have a body mass index (BMI) ≥23.0 kilogram/square meter (kg/m²) at screening.

Exclusion Criteria:

* Have Type 1 Diabetes
* Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening, or between screening and randomization.
* Currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
* Have New York Heart Association functional classification IV congestive heart failure.
* Have acute or chronic pancreatitis

Locations (89)

Sheffield, Alabama, United States
Surprise, Arizona, United States
Tucson, Arizona, United States
Escondido, California, United States
Huntington Park, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Norco, California, United States
San Ramon, California, United States
Tustin, California, United States
Cromwell, Connecticut, United States
Coconut Creek, Florida, United States
DeLand, Florida, United States
Maitland, Florida, United States
Miami Lakes, Florida, United States
Ocoee, Florida, United States
Stockbridge, Georgia, United States
Union City, Georgia, United States
Idaho Falls, Idaho, United States
Muncie, Indiana, United States
Wichita, Kansas, United States
New Orleans, Louisiana, United States
Dearborn, Michigan, United States
Billings, Montana, United States
Brooklyn, New York, United States
Manlius, New York, United States
Monroe, North Carolina, United States
New Bern, North Carolina, United States
Dublin, Ohio, United States
Norman, Oklahoma, United States
+ 59 more on CT.gov