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 (J2A-MC-GZGW)

Eli Lilly Japan K.K.0 个研究点目标入组 520 人开始时间: 2024年1月4日最近更新: 2024年11月19日

适应症

试验速览

暂无简介。

•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:
•insulin glargine U-100 (100 U/mL) >=0.20 U/kg/QD (units per kilogram per day) or >=15 U/QD alone, or
•insulin glargine U-100 (100 U/mL)>=0.20 U/kg/QD or >=15 U/QD in combination with
•metformin, or
•SGLT-2 inhibitor.
•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.

•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.
•acute myocardial infarction
•cerebrovascular accident (stroke), or
•hospitalization for congestive heart failure.
•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.

Change from Baseline in Hemoglobin A1c (HbA1c)

时间窗: Baseline, Week 40

Orforglipron Dose 1, 2

未报告次要终点

发起方