NCT06109311已完成3 期
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
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 546
- 试验地点
- 70
- 主要终点
- Orforglipron Dose 1, 2: Change from Baseline in Hemoglobin A1c (HbA1c)
研究概览
简要总结
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.
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 (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) ≥0.25 U/kg/QD (units per kilogram per day) or ≥20 U/QD alone, or
- •insulin glargine U-100 (100 U/mL) ≥0.25 U/kg/QD or ≥20 U/QD in combination with
- •metformin, or
- •SGLT-2 inhibitor, or
- •both metformin and 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.
排除标准
- •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.
研究组 & 干预措施
Orforglipron Dose 1
Experimental
Participants will receive orforglipron orally.
干预措施: Orforglipron (Drug)
Orforglipron Dose 2
Experimental
Participants will receive orforglipron orally.
干预措施: Orforglipron (Drug)
Orforglipron Dose 3
Experimental
Participants will receive orforglipron orally.
干预措施: Orforglipron (Drug)
Placebo
Placebo Comparator
Participants will receive placebo orally.
干预措施: Placebo (Drug)
结局指标
主要结局
Orforglipron Dose 1, 2: Change from Baseline in Hemoglobin A1c (HbA1c)
时间窗: Baseline, Week 40
次要结局
- Percentage Change from Baseline in non-HDL (non-high-density lipoprotein) Cholesterol(Baseline, Week 40)
- Change from Baseline in Body Weight(Baseline, Week 40)
- Percentage of Participants Who Achieved HbA1c <7.0% (53 millimoles per mole (mmol/mol))(Baseline to Week 40)
- Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/mol)(Baseline to Week 40)
- Percentage Change from Baseline in Body Weight(Baseline, Week 40)
- Percentage of Participants Who Achieved Weight Loss of ≥10%(Baseline to Week 40)
- Orforglipron Dose 3: Change from Baseline in HbA1c(Baseline, Week 40)
- Change from Baseline in Fasting Serum Glucose(Baseline, Week 40)
- Percentage of Participants Who Achieved Weight Loss of ≥15% from Baseline(Baseline to Week 40)
- Percentage Change from Baseline in Triglycerides(Baseline, Week 40)
- Change from Baseline in Systolic Blood Pressure(Baseline, Week 40)
- Change from Baseline in Daily Insulin Glargine Dose(Baseline, Week 40)
- Percentage of Participants Who Achieved Weight Loss of ≥5%(Baseline to Week 40)
- Change from Baseline in Short Form 36-Version 2 (SF-36v2) Acute Form Domain and Summary Scores(Baseline, Week 40)
研究者
研究点 (70)
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