A Phase 2, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Olatorepatide, a GLP-1/GIP Receptor Agonist, With Different Doses and Drug-Titration Algorithms in Participants Living With Overweight or Obesity

Regeneron Pharmaceuticals5 个研究点分布在 1 个国家目标入组 360 人开始时间: 2026年7月28日最近更新: 2026年8月20日

适应症

干预措施

试验速览

阶段: 2 期
状态: 招募中
发起方: Regeneron Pharmaceuticals
入组人数: 360
试验地点: 5
主要终点: Severity of TEAEs

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study will test an experimental drug called olatorepatide ("study drug") to determine how safe and effective this drug is compared to placebo and how easily the body can accept this drug at different doses and dosing schedules without causing side effects, as well as how the drug is processed in the body by participants with overweight or obesity but do not have diabetes.

The study is looking at:

What side effects the study drug might cause
How much study drug is in the blood at different times
How well the study drug works
What effects the study drug may have on the body at different dosing schedules
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 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Body Mass Index (BMI) ≥30.0 kg/m^2 to <45.0 kg/m^2 at screening OR
•BMI ≥27.0 kg/m^2 at screening with at least 1 of the following weight-related co-morbidities: Hypertension, Dyslipidemia, Prediabetes, established Obstructive Sleep Apnea (OSA), established Coronary Artery Disease (CAD), Heart failure, established cerebrovascular disease as described in the protocol

排除标准

•Previous or current diagnosis of Type 1 or Type 2 diabetes at screening
•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 as described in the protocol
•History of acute or chronic pancreatitis, cholecystitis, or symptomatic gallbladder stones
•History or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
•Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

研究组 & 干预措施

Matching Placebo arm 6

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干预措施: Placebo (Drug)