NCT06897475招募中2 期
A Parallel-Group Treatment, Phase 2, Double-Blind Study of Once-Weekly Subcutaneous LY3457263 Compared to Placebo in Participants With Type 2 Diabetes Mellitus on a Stable Dose of Semaglutide or Tirzepatide Who Failed to Achieve HbA1c Goal
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 60
- 主要终点
- Change from Baseline in Hemoglobin A1c (HbA1c)
研究概览
简要总结
The purpose of this study is to measure the change in hemoglobin A1c (HbA1c) with LY3457263 compared with placebo in participants with type 2 diabetes who are not at HbA1c goal when treated with a stable dose of semaglutide or tirzepatide. Participation in the study will last about 9 months.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have type 2 diabetes
- •Have HbA1c ≥7.5% to ≤10.5% at screening
- •Have a body mass index (BMI) of ≥27 kilograms per square meter (kg/m2) at screening
- •Have had a stable body weight for the three months prior to screening
- •On stable treatment dose of one of the following incretins for at least three months prior to screening:
- •Injectable semaglutide (1 and 2 milligram (mg))
- •Injectable tirzepatide (5, 7.5, 10, 12.5 and 15 mg)
排除标准
- •Have type 1 diabetes, latent autoimmune diabetes, or history of ketoacidosis or hyperosmolar coma
- •Have a prior or planned surgical treatment for obesity
- •Have any of the following cardiovascular conditions within three months prior to screening:
- •acute myocardial infarction
- •cerebrovascular accident (stroke)
- •unstable angina, or
- •hospitalization due to congestive heart failure
- •Have used insulin to control blood glucose within the past year (short-term use allowed)
- •Current use of prohibited oral antihyperglycemic medication (OAM) (including but not limited to, Dipeptidyl Peptidase IV Inhibitors (DPP-4i) and meglitinides) may be randomized if the prohibited OAM treatment was discontinued at least 3 months prior to screening
- •If participant has been on stable doses (for at least three months) of up to three permitted OAMs (limited to metformin, sodium-glucose cotransporter-2 (SGLT2) inhibitors, alpha-glucosidase inhibitors, sulfonylurea, and/or thiazolidinediones (TZD), they are permitted to participate in the study
- •Have taken any medications or alternative remedies for weight loss within three months prior to screening
研究组 & 干预措施
LY3457263 Dose 1
Experimental
Participants will receive LY3457263 subcutaneously (SC)
干预措施: LY3457263 (Drug)
LY3457263 Dose 2
Experimental
Participants will receive LY3457263 SC
干预措施: LY3457263 (Drug)
Placebo
Placebo Comparator
Participants will receive placebo SC
干预措施: Placebo (Drug)
LY3457263 Dose 3
Experimental
Participants will receive LY3457263 SC
干预措施: LY3457263 (Drug)
结局指标
主要结局
Change from Baseline in Hemoglobin A1c (HbA1c)
时间窗: Baseline, Week 24
次要结局
- Change from Baseline in Fasting Serum Glucose(Baseline, Week 24)
- Percent Change from Baseline in Body Weight(Baseline, Week 24)
研究者
研究点 (60)
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