NCT06010004已完成3 期
A Phase 3, Long-term Safety Study of LY3502970 in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone or in Combination With Oral Antihyperglycemic Medications (ACHIEVE-J)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 401
- 试验地点
- 75
- 主要终点
- Number of Participants with Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
The purpose of this study is to determine the long-term safety of the study intervention orforglipron as a monotherapy or in combination with oral antihyperglycemic medication.
This study includes 3 periods as follows:
- screening and lead-in period: up to 4 weeks
- treatment period: 52 weeks, including 20 weeks of dose escalation, and
- safety follow-up period: 2 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
- None
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) as determined by the central laboratory at screening.
- •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 BMI ≥23.0 kilogram/square meter (kg/m²) at screening.
排除标准
- •Have Type 1 Diabetes (T1D).
- •Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening, or between screening and randomization.
- •Have New York Heart Association functional classification IV congestive heart failure.
- •Have had any of the following cardiovascular (CV) conditions within 60 days prior to screening, or between screening and randomization.
- •acute myocardial infarction
- •cerebrovascular accident (stroke), or
- •hospitalization for congestive heart failure
- •Have acute or chronic hepatitis and pancreatitis
研究组 & 干预措施
Orforglipron Dose 1
Experimental
Participants will receive orforglipron administered orally.
干预措施: Orforglipron (Drug)
Orforglipron Dose 2
Experimental
Participants will receive orforglipron administered orally.
干预措施: Orforglipron (Drug)
Orforglipron Dose 3
Experimental
Participants will receive orforglipron administered orally.
干预措施: Orforglipron (Drug)
结局指标
主要结局
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
时间窗: Baseline through Week 52
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
时间窗: Baseline to Week 54
A TEAE was defined as any adverse event that began on or after the first dose of study drug or began before the first dose of study drug and worsened on or after the first dose of study drug.
次要结局
- Percentage of Participants who Achieve HbA1c <7.0% (<53 mmol/mol)(Week 52)
- Change from Baseline in Body Mass Index (BMI)(Baseline, Week 52)
- Change from Baseline in Hemoglobin A1c (HbA1c)(Baseline, Week 52)
- Percentage of Participants who Achieve HbA1c <5.7% (<39 mmol/mol)(Week 52)
- Change from Baseline in Body Weight(Baseline, Week 52)
- Percentage of Participants who Achieve Weight Loss of ≥15%(Week 52)
- Change from Baseline in Waist Circumference(Baseline, Week 52)
- Change from Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG)(Baseline, Week 52)
- Percentage of Participants who Achieve HbA1c ≤6.5% (<48 mmol/mol)(Week 52)
- Percentage of Participants who Achieve Weight Loss of ≥5%(Week 52)
- Change from Baseline in Fasting Serum Glucose(Baseline, Week 52)
- Percentage of Participants who Achieve Weight Loss of ≥10%(Week 52)
- Change From Baseline in Hemoglobin A1c (HbA1c)(Baseline, Week 52)
- Percentage of Participants Who Achieved HbA1c <7.0%(Week 52)
- Percentage of Participants Who Achieved HbA1c ≤6.5%(Week 52)
- Percentage of Participants Who Achieved HbA1c <5.7%(Week 52)
- Change From Baseline in Fasting Serum Glucose(Baseline, Week 52)
- Change From Baseline in Body Weight(Baseline, Week 52)
- Percentage of Participants Who Achieved Weight Loss of ≥5% From Baseline(Week 52)
- Percentage of Participants Who Achieved Weight Loss of ≥10% From Baseline(Week 52)
- Percentage of Participants Who Achieved Weight Loss of ≥15% From Baseline(Week 52)
- Change From Baseline in Waist Circumference(Baseline, Week 52)
- Change From Baseline in Body Mass Index (BMI)(Baseline, Week 52)
- Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG)(Baseline, Week 52)
研究者
研究点 (75)
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