NCT07458269进行中（未招募）2 期
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes
Kailera35 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2026年3月4日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 264
- 试验地点
- 35
- 主要终点
- Percent Change From Baseline in Body Weight at Week 48
研究概览
简要总结
The primary objective of this study is to determine the effects of ribupatide administered by subcutaneous (SC) injection once weekly compared to placebo on percent change in body weight.
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
- Double (Participant, Investigator)
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
- •BMI ≥35 kilograms per meter squared (kg/m^2).
- •History of at least 1 self-reported unsuccessful effort to lose weight with diet and exercise within the prior 6 months.
排除标准
- •Current diagnosis or history of diabetes mellitus, including type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM), history of diabetic ketoacidosis, or hyperosmolar state/coma.
- •Started medications within 3 months prior to Screening that may cause significant weight gain, including, but not limited to, tricyclic antidepressants, atypical antipsychotics, and mood stabilizers.
- •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 gastrointestinal motility.
- •History of suicide attempt.
- •History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder within 2 years prior to Screening.
- •Received treatment with semaglutide, tirzepatide, glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1R/glucose-dependent insulinotropic polypeptide receptor (GIPR), or glucagon receptor agonist within 3 months prior to Screening.
- •Note: Additional inclusion/exclusion criteria may apply, per protocol.
研究组 & 干预措施
Placebo
Placebo Comparator
Participants will receive placebo matched to ribupatide once weekly.
干预措施: Placebo (Drug)
Ribupatide: Dose 3
Experimental
Participants will receive Dose 3 of ribupatide once weekly.
干预措施: Ribupatide (Drug)
Ribupatide: Dose 4
Experimental
Participants will receive Dose 4 of ribupatide once weekly.
干预措施: Ribupatide (Drug)
Ribupatide: Dose 1
Experimental
Participants will receive Dose 1 of ribupatide once weekly.
干预措施: Ribupatide (Drug)
Ribupatide: Dose 2
Experimental
Participants will receive Dose 2 of ribupatide once weekly.
干预措施: Ribupatide (Drug)
结局指标
主要结局
Percent Change From Baseline in Body Weight at Week 48
时间窗: Baseline, Week 48
次要结局
- Percent Change From Baseline in Fasting High-density Lipoprotein (HDL)-cholesterol(Baseline, Week 48)
- Percent of Participants with ≥5%, ≥10%, ≥15%, ≥20% and ≥25% Reduction From Baseline in Body Weight(Baseline, Week 48)
- Percent Change From Baseline in Fasting Non-HDL-cholesterol(Baseline, Week 48)
- Change From Baseline in Waist Circumference(Baseline, Week 48)
- Change From Baseline in Absolute Body Weight(Baseline, Week 48)
- Change From Baseline in Body Mass Index (BMI)(Baseline, Week 48)
- Percent Change From Baseline in Fasting Triglycerides(Baseline, Week 48)
- Percent Change From Baseline in Fasting Total Cholesterol(Baseline, Week 48)
- Percent Change From Baseline in Fasting Low-density Lipoprotein (LDL)-cholesterol(Baseline, Week 48)
- Percent Change From Baseline in Fasting Very Low-density Lipoprotein (VLDL)-cholesterol(Baseline, Week 48)
- Percent Change From Baseline in Fasting Insulin(Baseline, Week 48)
- Change From Baseline in Fasting Blood Glucose(Baseline, Week 48)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(Day 1 up to Week 52)
- Number of Participants With Anti-drug Antibodies (ADAs)(Day 1 up to Week 52)
- Number of Participants With Neutralizing Antibodies (NAbs)(Day 1 up to Week 52)
- Plasma Concentrations of KAI-9531(Day 1 up to Week 52)
研究者
研究点 (35)
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