A Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Macupatide Monotherapy, and Macupatide in Combination With Eloralintide, in Japanese Participants With Obesity or Overweight Without Type 2 Diabetes.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Number of Participants with One or More 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 assess how well macupatide, when dosed alone and in combination with eloralintide, is tolerated and what side effects may occur in participants with obesity or overweight without 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. For each participant, the study will last about 4 months and will include 2 stays in the Clinical Research Unit (CRU), each lasting 3-5 nights.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 基础科学
- 盲法
- 双盲 (受试者、研究者)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- Are Japanese participants assigned male at birth (AMAB) or assigned female at birth (AFAB) who agree to contraception requirements or participants who are individuals not of childbearing potential (INOCBP).
- Have a body mass index greater than or equal to (≥)25 kilograms per square meter (kg/m²)
- Have had a stable weight for the 3 months prior to screening. Stable weight is defined as less than 5 percent (%) body weight change.
排除标准
- Have known allergies to related compounds of macupatide or eloralintide, or any components of the formulations.
- Have a history of significant atopy, including severe allergic manifestations, or clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions.
- Have a history or presence of psychiatric disorders, including a history of major depressive disorder or severe psychiatric disorders, within the last 3 years, that would present a safety risk or may significantly impair the participant's ability to comply with study procedures.
- Have been diagnosed with Type 1 or Type 2 diabetes mellitus.
- Have a history of chronic medical conditions involving the heart, liver, or kidneys.
- Have a history of any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Have a history or presence of a gastrointestinal (GI) disorder or previous surgery that impacts gastric emptying.
- Have had or plan to have during the study, a device-based or surgical treatment use for obesity.
- Have been treated, or plan to be treated, with prescription medications or other non approved drugs intended to promote weight loss, within 3 months prior to screening.
- Are currently enrolled or have participated, within the last 30 days, in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed.
- Have previously completed or withdrawn from this study or have previously received macupatide or eloralintide.
- Have evidence of acute or chronic liver disease or pancreatic disease.
研究组 & 干预措施
Macupatide ＋ placebo
Macupatide and placebo administered subcutaneously (SC)
干预措施: Placebo (Drug)
Eloralintide + placebo
Eloralintide and placebo administered SC
干预措施: Placebo (Drug)
Placebo
Placebo administered SC
干预措施: Placebo (Drug)
Macupatide Dose B + Eloralintide
Macupatide and Eloralintide administered SC
干预措施: Eloralintide (Drug)
Macupatide ＋ placebo
Macupatide and placebo administered subcutaneously (SC)
干预措施: Macupatide (Drug)
Macupatide Dose A + Eloralintide
Macupatide and Eloralintide administered SC
干预措施: Eloralintide (Drug)
Macupatide Dose B + Eloralintide
Macupatide and Eloralintide administered SC
干预措施: Macupatide (Drug)
Eloralintide + placebo
Eloralintide and placebo administered SC
干预措施: Eloralintide (Drug)
Macupatide Dose A + Eloralintide
Macupatide and Eloralintide administered SC
干预措施: Macupatide (Drug)
结局指标
主要结局
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: End of Study (Week 25)
次要结局
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Macupatide(Baseline through Week 25)
- PK: AUC of Macupatide in Combination with Eloralintide(Baseline through Week 25)
- PK: Maximum Concentration (Cmax) of Macupatide(Baseline through Week 25)
- PK: Cmax of Macupatide in Combination with Eloralintide(Baseline through Week 25)
- Percent Change in Body Weight(Baseline through Week 25)
研究者
研究点 (3)
标识符
- NCT 编号
- NCT07765511
- 其他研究编号
- 27505, J2V-JE-GZLE
日期
- 首次提交
- (上个月)
- 首次发布
- (上个月)
- 主要完成日期
- (8个月后)
- 研究完成日期
- (8个月后)
- 最近核实
- (2个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否