A Phase 2, Parallel-Group, Double-Blind, Placebo-Controlled Study to Investigate Weight Reduction With Macupatide and Eloralintide, Alone or in Combination, in Adult Participants With Obesity or Overweight and With Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 74
- 主要终点
- Percent Change from Baseline in Body Weight
研究概览
简要总结
The purpose of this study is to investigate weight reduction with macupatide and eloralintide, alone or in combination, in adult participants with obesity or overweight and with type 2 diabetes. Participation in the study will last about 48 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
- 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 an HbA1c ≥7.5% to ≤10.5% at screening
- •Have been treated with any of the following, alone or in combination, for at least 3 months prior to screening
- •Diet and exercise
- •Stable dose of metformin
- •Sodium-glucose cotransporter-2 (SGLT2) inhibitor
- •Have had a stable body weight (<5% body weight gain and/or loss) for the 3 months prior to screening
- •Have a BMI of 27 or greater at screening
排除标准
- •Have any form of diabetes other than type 2 diabetes
- •Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed >1 year prior to screening
- •Have any of the following cardiovascular conditions within 3 months prior to screening:
- •acute myocardial infarction
- •cerebrovascular accident (stroke)
- •unstable angina, or
- •hospitalization due to congestive heart failure
- •Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years, exceptions include
- •basal or squamous cell skin cancer
- •in situ carcinomas of the cervix, or
- •in situ prostate cancer
- •Have been prescribed any of the following receptor agonists (RA) or their combination for any indication within the last 6 months:
- •amylin RA
- •dual amylin and calcitonin RA
- •glucagon-like peptide-1 receptor (GLP-1) RA
- •glucose-dependent insulinotropic peptide (GIP)/GLP-1 RA
- •GLP-1/glucagon (GCG) RAs, or
- •GIP/GLP-1/GCG RAs
- •Have used excluded antihyperglycemic medications within 3 months prior to screening (including, but not limited to, sulfonylureas, dipeptidyl peptidase-4 inhibitors, alpha-glucosidase inhibitors, thiazolidinediones, and meglitinides
- •Have used insulin for diabetic control within the prior year (short term use in certain situations allowed
研究组 & 干预措施
Placebo (Macupatide Placebo + Elorlintide Placebo)
Participants will be administered eloralintide placebo SC and macupatide placebo SC
干预措施: Macupatide Placebo (Drug)
Placebo (Macupatide Placebo + Elorlintide Placebo)
Participants will be administered eloralintide placebo SC and macupatide placebo SC
干预措施: Eloralintide Placebo (Drug)
Macupatide + Eloralintide
Participants will be administered eloralintide SC and macupatide SC
干预措施: Eloralintide (Drug)
Macupatide + Eloralintide
Participants will be administered eloralintide SC and macupatide SC
干预措施: Macupatide (Drug)
Eloralintide (Elorlintide + Macupatide Placebo)
Participants will be administered eloralintide SC and macupatide placebo SC
干预措施: Eloralintide (Drug)
Macupatide (Macupatide + Eloralintide Placebo)
Participants will be administered macupatide subcutaneously (SC) and eloralintide placebo SC
干预措施: Eloralintide Placebo (Drug)
Eloralintide (Elorlintide + Macupatide Placebo)
Participants will be administered eloralintide SC and macupatide placebo SC
干预措施: Macupatide Placebo (Drug)
Macupatide (Macupatide + Eloralintide Placebo)
Participants will be administered macupatide subcutaneously (SC) and eloralintide placebo SC
干预措施: Macupatide (Drug)
结局指标
主要结局
Percent Change from Baseline in Body Weight
时间窗: Baseline, Week 32
次要结局
- Change from Baseline in Hemoglobin A1c (HbA1c)(Baseline, Week 32)
- Change from Baseline in Body Mass Index (BMI)(Baseline, Week 32)
- Change from Baseline in Fasting Glucose(Baseline, Week 32)