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

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT05971940

Run by

Eli Lilly and Company

People needed

559

Starts

2023-08-09

Expected to finish

2025-04-03

Last updated by the study team

2026-04-22

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Epic Medical Research - Surprise — Surprise, Arizona, United States
• Quality of Life Medical & Research Center — Tucson, Arizona, United States
• Neighborhood Healthcare Institute of Health — Escondido, California, United States
• Velocity Clinical Research, Huntington Park — Huntington Park, California, United States
• Ark Clinical Research — Long Beach, California, United States
• Velocity Clinical Research, Westlake — Los Angeles, California, United States
• Infinity Clinical Research - Norco — Norco, California, United States
• Norcal Endocrinology & Internal Medicine — San Ramon, California, United States
• University Clinical Investigators, Inc. — Tustin, California, United States
• Connecticut Clinical Research - Cromwell — Cromwell, Connecticut, United States
• Invictus Clinical Research Group — Coconut Creek, Florida, United States
• Hillcrest Medical Research — DeLand, Florida, United States
• K2 Medical Research — Maitland, Florida, United States
• Global Health Research Center, Inc. — Miami Lakes, Florida, United States
• West Orange Endocrinology — Ocoee, Florida, United States
• Clinical Research Atlanta — Stockbridge, Georgia, United States
• Rophe Adult and Pediatric Medicine/SKYCRNG — Union City, Georgia, United States
• Family First Medical Center — Idaho Falls, Idaho, United States
• American Health Network of Indiana, LLC - Muncie — Muncie, Indiana, United States
• Tekton Research - Wichita — Wichita, Kansas, United States
• Alliance for Multispecialty Research, LLC — New Orleans, Louisiana, United States
• Revival Research Institute — Dearborn, Michigan, United States
• Billings Clinic — Billings, Montana, United States
• Ellipsis Research Group - Brooklyn - 7th Street — Brooklyn, New York, United States
• Syed Research Consultants Llc — Sheffield, Alabama, United States

Full record on ClinicalTrials.gov

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