A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Number of Participants with One or More Serious Adverse Event(s) (SAEs) and Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration
研究概览
简要总结
The purpose of this study is to evaluate how well LY4057996 is tolerated and what side effects may occur in healthy participants and participants with Type 1 and Type 2 Diabetes. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm). Blood tests will be performed to check how much LY4057996 gets into the bloodstream and how long it takes the body to eliminate it.
The study will last 11 weeks for Part A1-A2, 4 weeks for A3-A5, 6 weeks for Part B and 7 weeks for Part C, all approximations, excluding a screening period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Part A is Double-Blinded, Parts B and C are Open-Label
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Part A for Healthy Participants:
- •Are overtly healthy as determined by medical evaluation, including medical history, physical exam, laboratory tests, and cardiac screening assessment
- •Part A for Type 2 Diabetes (T2DM) Participants:
- •Are participants with T2DM diagnosed greater than 1 year before enrollment,
- •On basal insulin therapy, insulin glargine, insulin detemir, or insulin degludec, greater than 10 units per day for at least 6 months (for Cohort 5 only)
- •Glycated hemoglobin (HbA1c) 6.5% to 9.5% inclusive at screening
- •Have Type 1 Diabetes (T1D) for at least 1 year with a fasting C-peptide level of 0.20 nanomole per liter (nmol/L) or less or non-fasting C-peptide level of 0.30 nmol/L or less at screening
- •HbA1c 6% to 8.5% inclusive at screening
- •Have T1D for at least 1 year with a fasting C-peptide level of 0.20 nanomole per liter (nmol/L) or less or non-fasting C-peptide level of 0.30 nmol/L or less at screening
- •HbA1c 6 to 8.5% inclusive at screening
- •Have blood pressure of less than 140/90 millimeters of mercury (mmHg) for healthy participants or 150/90 mmHg for participants with diabetes and pulse rate of less than 90 beats per minute (bpm) (supine)
- •No hypoglycemia unawareness for all Type 1 and Type 2 Diabetes participants
排除标准
- •Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within 6 months prior to screening
- •Have had any episodes of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia), hypoglycemia unawareness, or both within the 6 months prior to screening
- •Cardiovascular: no significant history of cardiovascular disease (CVD)
- •Gastrointestinal: have gastroparesis or have undergone gastric surgery
- •Hepatic: have acute or chronic hepatitis
研究组 & 干预措施
LY4057996 Part A (Cohorts A1-A5)
LY4057996 administered subcutaneously (SC) and/or intravenously (IV)
干预措施: LY4057996 SC (Drug)
LY4057996 Part A (Cohorts A1-A5)
LY4057996 administered subcutaneously (SC) and/or intravenously (IV)
干预措施: LY4057996 IV (Drug)
Placebo Part A (Cohort A1-A5)
Placebo administered SC and/or IV
干预措施: Placebo SC (Drug)
Placebo Part A (Cohort A1-A5)
Placebo administered SC and/or IV
干预措施: Placebo IV (Drug)
LY4057996 Part B
LY4057996 administered SC
干预措施: LY4057996 SC (Drug)
LY4057996 Part C
LY4057996 and interventions of pre-study basal insulin and Lispro administered SC
干预措施: LY4057996 SC (Drug)
LY4057996 Part C
LY4057996 and interventions of pre-study basal insulin and Lispro administered SC
干预措施: Lispro SC (Drug)
LY4057996 Part C
LY4057996 and interventions of pre-study basal insulin and Lispro administered SC
干预措施: Pre-study basal insulin SC (Drug)
Degludec Part A (Cohort A2-A5)
Degludec administered SC and/or IV
干预措施: Degludec SC (Drug)
Degludec Part A (Cohort A2-A5)
Degludec administered SC and/or IV
干预措施: Degludec IV (Drug)
Degludec Part B
Degludec administered SC
干预措施: Degludec SC (Drug)
结局指标
主要结局
Number of Participants with One or More Serious Adverse Event(s) (SAEs) and Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline to Study Completion (Up to 47 Weeks)
A summary of SAEs and AEs regardless of causality, will be reported in the Reported Adverse Events module
次要结局
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4057996(Baseline to Study Completion (Up to 47 Weeks))
- PK: Maximum Concentration (Cmax) of LY4057996(Baseline to Study Completion (Up to 47 Weeks))
- Pharmacodynamic (PD): Change from Baseline in Fasting Glucose(Baseline to Study Completion (Up to 47 Weeks))
- PD: AUC of Glucose Infusion Rate (GIR)(Baseline Up to 10 weeks)