A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once Daily Oral LY3502970 Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 559
- 试验地点
- 162
- 主要终点
- Change from Baseline in Hemoglobin A1c (HbA1c)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Placebo
Participants received once daily (QD) doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks.
干预措施: Placebo (Drug)
3 mg Orforglipron
Participants received orforglipron capsules administered orally QD, starting at 1 milligram (mg) and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40.
干预措施: Orforglipron (Drug)
12 mg Orforglipron
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40.
干预措施: Orforglipron (Drug)
36 mg Orforglipron
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40.
干预措施: Orforglipron (Drug)
结局指标
主要结局
Change from Baseline in Hemoglobin A1c (HbA1c)
时间窗: Baseline, Week 40
Change From Baseline in HbA1c
时间窗: Baseline, Week 40
* Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A, measured to reflect average plasma glucose concentration over prolonged periods of time. * Values represented under "Least Squares (LS) Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤ \[less than or equal to\] 8.0%, \> \[greater than\] 8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.
次要结局
- Percentage of Participants with an HbA1c target value of <7.0% (53 mmol/mol)(Week 40)
- Percentage of Participants with an HbA1c target value of ≤6.5% (48 mmol/mol)(Week 40)
- Change from Baseline in Fasting Serum Glucose(Baseline, Week 40)
- Percentage Change from Baseline in Body Weight(Baseline, Week 40)
- Change from Baseline in Body Weight(Baseline, Week 40)
- Change from Baseline in Daily Average 7-point Self-Monitored Blood Glucose (SMBG)(Baseline, Week 40)
- Change from Baseline in Systolic Blood Pressure (SBP)(Baseline, Week 40)
- Change from Baseline in Non-HDL Cholesterol(Baseline, Week 40)
- Percentage Change from Baseline in Triglycerides(Baseline, Week 40)
- Percentage of Participants Who Achieved Weight Loss of ≥5%(Week 40)
- Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Scores(Baseline, Week 40)
- Percentage of Participants With an HbA1c Target Value of < 7.0% (53 mmol/Mol)(Week 40)
- Percentage of Participants With an HbA1c Target Value of ≤6.5% (48 mmol/Mol)(Week 40)
- Change From Baseline in Fasting Serum Glucose (FSG)(Baseline, Week 40)
- Percent Change From Baseline in Body Weight(Baseline, Week 40)
- Change From Baseline in Body Weight(Baseline, Week 40)
- Percent Change From Baseline in Non-High-Density Lipoprotein (Non-HDL) Cholesterol(Baseline, Week 40)
- Percent Change From Baseline in Triglycerides(Baseline, Week 40)
- Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG)(Baseline, Week 40)
- Percentage of Participants With Greater Than or Equal to (≥) 5% Body Weight Reduction(Week 40)
- Change From Baseline in Systolic Blood Pressure (SBP)(Baseline, Week 40)
- Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Acute Form (Physical-Component and Mental-Component) Scores(Baseline, Week 40)