A Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3502970 in Japanese Participants With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 9
- 主要终点
- Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
研究概览
简要总结
The main purpose of this study is to learn about the side effects of LY3502970 when given to Japanese participants with type 2 diabetes mellitus (T2DM). Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. For each participant, the study will last up to 24 weeks, inclusive of screening and will include 10 visits to the study center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females not of childbearing potential
- •Have type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year
- •Have glycated hemoglobin (HbA1c) value ≥ 7.0% and ≤ 10.0% for participants treated with diet and exercise or HbA1c ≥ 6.5% and ≤ 9.0% for participants who have washed out antidiabetic medications at screening
- •Have type 2 diabetes controlled with diet and exercise alone or are stable on a single oral antidiabetic medication (OAM); either metformin, DPP-4 (dipeptidyl peptidase-4) inhibitor, or SGLT2 (sodium-glucose co-transporter-2) inhibitor within 3 months prior to screening. Participants must withdraw from their OAM treatment for at least 28 days prior to dosing.
排除标准
- •Have type 1 diabetes mellitus or latent autoimmune diabetes in adults.
- •Have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization
- •Have had an episode of severe hypoglycemia, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery or have a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.
- •Have a history of acute or chronic pancreatitis or fasting serum triglyceride level of >500 milligram per deciliter (mg/dL).
- •Have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aminotransferases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) greater than 3× upper limit of normal (ULN).
研究组 & 干预措施
LY3502970 (Part A)
Single doses of LY3502970 administered orally.
干预措施: LY3502970 (Drug)
LY3502970 (Part B)
Multiple doses of LY3502970 administered orally.
干预措施: LY3502970 (Drug)
Placebo (Part B)
Participants received placebo administered orally.
干预措施: Placebo (Drug)
Placebo (Part A)
Participants received placebo administered orally.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline through Week 15
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline Through Follow-Up (Up To Week 15)
A TEAE is an untoward medical occurrence that emerges during a defined treatment period, having been absent pretreatment, or worsens relative to the pretreatment state, and does not necessarily have to have a causal relationship with this treatment. An SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience, persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. An overall summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
次要结局
- Change from Baseline in Fasting Glucose(Baseline through Day 85)
- PK: Area Under the Concentration Versus Time Curve (AUC) of LY3502970(Predose on Day 1 through up to Day 88)
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3502970(Predose on Day 1 through up to Day 88)
- Change from Baseline in Glycated Hemoglobin (HbA1c)(Baseline through Day 85)
- Change from Baseline in Body Weight(Baseline through Day 88)
- Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3502970 on Day 1(Day 1 (Pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72 and 96 hours post-dose))
- Part A: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3502970 on Day 1(Day 1 (Pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72 and 96 hours post-dose))
- Part B: PK: Cmax of LY3502970 on Day 84(Day 84 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96 and 336 hours post-dose))
- Part B: PK: AUC[0-tlast] of LY3502970 on Day 84(Day 84 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96 and 336 hours post-dose))
- Change From Baseline in Fasting Glucose(Baseline through Day 85)
- Change From Baseline in Glycated Hemoglobin (HbA1c)(Baseline through Day 85)
- Change From Baseline in Body Weight(Baseline through Day 88)