2025-523486-17-00招募中3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living with Obesity or Overweight with Weight-Related Comorbidities Who Do Not Have Diabetes
Kailera Therapeutics Inc.58 个研究点 分布在 6 个国家目标入组 539 人开始时间: 2026年6月25日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 539
- 试验地点
- 58
研究概览
简要总结
To determine the effects of ribupatide SC QW compared to placebo on percent change in body weight
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •BMI ≥30 kg/m², or BMI ≥27 kg/m² with a prior diagnosis of at least one of the following: Hypertension Dyslipidemia Obstructive sleep apnea Cardiovascular disease
- •History of being unresponsive to at least 1 self-reported effort to lose weight with diet and/or exercise in the last 6 months.
排除标准
- •Current diagnosis or history of diabetes mellitus
- •Received treatment with semaglutide, tirzepatide, GLP-1 receptor agonist, GLP-1/GIP, or glucagon receptor agonist within 3 months prior to Screening.
- •Started medications within 3 months prior to Screening that may cause significant weight change, including, but not limited to, tricyclic antidepressants, atypical antipsychotics, mood stabilizers or phentermine.
- •Unstable weight defined as self-reported change in body weight exceeding 5% within 3 months prior to Screening.
- •Family or personal history of multiple endocrine neoplasia Type 2 or medullary thyroid cancer.
- •Uncontrolled hypertension or unstable cardiovascular disease
- •History of chronic or acute pancreatitis
- •Known clinically significant gastric-emptying abnormality or chronic treatment with medications that directly affect GI motility.
- •History of suicide attempt.
- •History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder
研究组 & 干预措施
Identical to kai-9531 solution for injection without active drug
Placebo
干预措施: Identical to kai-9531 solution for injection without active drug (Drug)
KAI-9531, KAI-9531, KAI-9531
Test
干预措施: KAI-9531 (Drug)
结局指标
主要结局
未指定
次要结局
- From baseline at Week 76 Percentage of participants with ≥5%,≥10%, ≥15%, ≥20%, and ≥25% reduction in body weight (kg) Change in waist circumference (cm) Change in absolute body weight (kg) Change (all ribupatide doses combined) in SBP (mm Hg) Percent change (all ribupatide doses combined) in (fasting): − Triglycerides (mg/dL) − HDL-cholesterol (mg/dL) − Non-HDL-cholesterol (mg/dL) Change (all ribupatide doses combined) in IWQOL-Lite-CT physical function composite score
- From baseline at Week 76:Percentage of participants with ≥30% reduction in body weight(kg).Change in BMI(kg/m2).Change(all ribupatide doses combined) in DBP (mm Hg).Percent change(all ribupatide doses combined) in(fasting):−Total cholesterol(mg/dL)−LDL-cholesterol(mg/dL)−VLDL-cholesterol(mg/dL). Percent change(all ribupatide doses combined) in fasting insulin (mIU/L).Change(all ribupatide doses combined) in fasting blood glucose (mg/dL).Change(all ribupatide doses combined) in COEQ
研究者
Kailera Therapeutics, Inc
Scientific
Kailera Therapeutics Inc.
研究点 (58)
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