Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3457263 Alone and in Combination With GLP-1 RA in Patients With Type 2 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 5
- 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 investigate the safety and tolerability of the study drug LY3457263 when administered alone or in combination with glucagon-like peptide 1 (GLP-1) receptor agonist (RA) in participants with type 2 diabetes. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study will last up to approximately 16 weeks excluding the screening period for each participant and include up to 17 visits.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with type 2 diabetes (T2D) at least 6 months before screening
- •Participants treated for T2D with diet and exercise, with or without metformin
- •Have a glycated hemoglobin A1c (HbA1c) value of ≥ 7.5% and ≤10.5%
- •Have had a stable body weight for 3 months and body mass index (BMI) of 27.0 to 45.0 kilograms per meter squared (kg/m²)
- •Male participants who agree to use effective methods of contraception and female participants not of childbearing potential
排除标准
- •Have a history of or current cardiovascular, respiratory, hepatic, renal, GI, endocrine (apart from T2D), hematological, or neurological disorders capable of altering the absorption, metabolism, or elimination of drugs
- •Have type 1 diabetes mellitus or latent autoimmune diabetes in adults or maturity-onset diabetes of the young
- •Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy
- •Have known allergies to GLP-1 receptor agonists
研究组 & 干预措施
LY3457263 (Alone)
LY3457263 administered subcutaneously (SC).
干预措施: LY3457263 (Drug)
Placebo (Alone)
Placebo administered SC.
干预措施: Placebo (Drug)
LY3457263 + Dulaglutide
LY3457263 in combination with dulaglutide administered SC.
干预措施: LY3457263 (Drug)
LY3457263 + Dulaglutide
LY3457263 in combination with dulaglutide administered SC.
干预措施: Dulaglutide (Drug)
Placebo + Dulaglutide
Placebo in combination with dulaglutide administered SC.
干预措施: Placebo (Drug)
Placebo + Dulaglutide
Placebo in combination with dulaglutide administered SC.
干预措施: Dulaglutide (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: Predose up to 16 weeks
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
次要结局
- PK: Area Under the Concentration Versus Time Curve (AUC) of LY3457263(Pre-dose on Day 1 up to 85 days post-dose)