NCT07476118进行中（未招募）1 期
A Phase 1b, Randomized, Investigator- and Participant-Blinded, Placebo-Controlled Multiple-Dose Study to Evaluate the Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Brenipatide in Healthy Participants With Overweight or Obesity
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Percent Change in Body Weight
研究概览
简要总结
The main purpose of this study is to evaluate how different dose levels of brenipatide work and how safe they are in healthy people with overweight or obesity. The study will assess the effects of different doses given as subcutaneous (under the skin) injections. Participation in this study will last about 42 weeks.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are overtly healthy with no comorbidities related to body mass index (BMI), such as type 2 diabetes mellitus or unstable cardiovascular disease, as determined by medical evaluation
- •Have a BMI within the range of 27.0 to 45.0 kilogram per square meter (kg/m^2)
- •Have no significant (not more than 5 percent [%]) self-reported weight gain or loss in the past 3 months prior to screening
排除标准
- •Have significant history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination; constituting a risk when taking the Investigational Medical Product (IMP); or interfering with the interpretation of data
- •Have a prior diagnosis of type 1 or type 2 diabetes mellitus
- •Have a history of acute or chronic pancreatitis
- •Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
- •Have received a glucagon-like peptide-1 (GLP-1) receptor agonist, glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 receptor agonist, GIP/GLP-1/glucagon receptor agonist, or amylin receptor agonist within 6 months prior to screening
- •Have been treated with prescription and over-the-counter medications, or alternative remedies (including herbal/nutritional supplements), that promote weight loss within 6 months prior to screening
- •Are pregnant or lactating
研究组 & 干预措施
Brenipatide
Experimental
Participants will receive brenipatide subcutaneously (SC).
干预措施: Brenipatide (Drug)
Placebo
Placebo Comparator
Participants will receive placebo administered SC.
干预措施: Placebo (Other)
结局指标
主要结局
Percent Change in Body Weight
时间窗: Week 1, Week 29
次要结局
- Number of Participants who discontinued due to an Adverse Events (AEs)(Day 1 through Week 37)
- Percentage of Participants Discontinuing Treatment due to Gastrointestinal (GI) AEs(Day 1 through Week 37)
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Brenipatide(Pre-dose on Day 1 through Week 37)
- PK: Maximum Concentration (Cmax) of Brenipatide(Pre-dose on Day 1 through Week 37)
- Percentage of Participants Achieving ≥ 5% Reduction in Body Weight(Week 29)
- Change in Waist Circumference(Week 1, Week 29)
- Change in Waist-to-Height Ratio(Week 1, Week 29)
- Change in Blood Pressure(Week 1, Week 29)
- Change in Fasting Low-density Lipoprotein- Cholesterol (LDL-C)(Week 1, Week 29)
- Change in High-sensitive C-reactive Protein (hsCRP)(Week 1, Week 29)
研究者
研究点 (3)
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