A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once Daily Oral Orforglipron Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor
A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once Daily Oral Orforglipron Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor
The main purpose of this study is to determine the safety and efficacy of orforglipron. Participants will have Type 2 Diabetes (T2D) and have inadequate glycemic control with insulin glargine with or without metformin and/or SGLT-2 (sodium-glucose cotransporter-2) inhibitor. The study will last about 46 weeks and may include up to 20 visits.
Inclusion Criteria:
Have Type 2 Diabetes (T2D)
Have HbA1c ≥7.0% [53 mmol/mol] to ≤10.5% [91 mmol/mol]
Have been treated with stable doses of the same formulation of the following for ≥90 days prior to screening visit 1 and have maintained the same doses through randomization:
Are of stable body weight (±5%) for at least 90 days prior to screening visit 1 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 kg/m^2 at baseline.
Exclusion Criteria:
Have New York Heart Association functional classification III-IV congestive heart failure.
Have had any of the following cardiovascular conditions within 60 days prior to baseline.
Have acute or chronic hepatitis, including a history of autoimmune hepatitis, signs or symptoms of any other liver disease other than nonalcoholic fatty liver disease
Have had chronic or acute pancreatitis any time.
Toluca Lake, California 91602, United States
São José dos Campos, São Paulo 12243-280, Brazil
Luoyang Shi, Henan 471003, China
Kamakura-shi, Kanagawa 247-0056, Japan
Chuo-ku, Tokyo 103-0002, Japan
Chuo-ku, Tokyo 103-0027, Japan
Chuo-ku, Tokyo 104-0031, Japan
Ootaku, Tokyo 143-0015, Japan