NCT07431086进行中（未招募）2 期
A Phase 2, Double-Blind, Placebo-Controlled Study to Assess the Pharmacokinetics, Safety, Tolerability, and Efficacy of Olatorepatide, a GLP-1/GIP Receptor Agonist, in Participants Living With Overweight or Obesity in the US
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Occurrence of Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
This study will test olatorepatide (study drug) to determine how safe and effective this drug is and how easily your body can accept this drug without causing side effects, as well as how the drug is processed in the body by participants with overweight or obesity.
The study will test how safe and effective the study drug works compared to placebo in people who are overweight or obese but do not have diabetes.
The study is looking at:
- What side effects the study drug might cause
- How much the study drug is in the blood at different times
- How well the study drug works
- If the body makes antibodies to the study drug as this may cause the study drug to not work as well
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Body mass index ≥27.0 kg/m^2 to <45.0 kg/m^2 at screening
- •Demonstrates ability and willingness to comply with the study protocol, including attending all scheduled visits, adhering to the prescribed treatment regimen, and completing all required assessment
排除标准
- •History of Type 1 or Type 2 diabetes
- •Change in body weight >5 kg within approximately 3 months before screening as described in the protocol
- •Bariatric surgery, including any procedures to revise, reverse, or remove any previous bariatric surgery interventions, prior to randomization or planned during the study period
- •History of any of the following conditions: acute or chronic pancreatitis, cholecystitis, or symptomatic gallbladder stones or has a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years as described in the protocol
- •Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
研究组 & 干预措施
Subgroup Cohort
Experimental
干预措施: Olatorepatide (Drug)
General Cohort
Experimental
干预措施: Placebo (Drug)
Subgroup Cohort
Experimental
干预措施: Placebo (Drug)
General Cohort
Experimental
干预措施: Olatorepatide (Drug)
结局指标
主要结局
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
时间窗: Up to approximately 30 weeks
Severity of TEAEs
时间窗: Up to approximately 30 weeks
Maximum plasma concentration (Cmax)
时间窗: At week 15 and week 24
Area Under the Concentration time curve from time 0 to 168 hours (AUC0-168h)
时间窗: At week 15 and week 24
次要结局
- Percent change in body weight(From baseline to week 25)
- Change in mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP)(From baseline to week 24)
- Change in in-clinic SBP(From baseline to week 24)
- Lowest concentration in a dosing interval (Ctrough)(Up to approximately 30 weeks)
- Time to Cmax (Tmax)(Up to approximately 30 weeks)
- Apparent Volume of distribution (Vd/F)(Up to approximately 30 weeks)
- Apparent clearance (CL/F)(Up to approximately 30 weeks)
- Apparent terminal half-life (t½)(Up to approximately 30 weeks)
- Olatorepatide concentrations(Up to approximately 30 weeks)
- Occurrence of Anti-Drug Antibody (ADA) to olatorepatide(Up to approximately 30 weeks)
- Magnitude of ADA to olatorepatide(Up to approximately 30 weeks)
- Corrected QT interval (QTc)(At 24 hours postdose)
研究者
研究点 (3)
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