NCT07284901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 and Diabetes
Kailera175 个研究点 分布在 3 个国家目标入组 1,156 人开始时间: 2026年1月12日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,156
- 试验地点
- 175
- 主要终点
- Doses 3 and 4 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76
研究概览
简要总结
The primary objective of this study is to demonstrate that ribupatide (KAI-9531) subcutaneous (SC) injection once weekly is superior to placebo on:
- Percent change in body weight
- Change in hemoglobin A1c (HbA1c)
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
- •Diagnosis of type 2 diabetes mellitus (T2DM).
- •Receiving stable therapy for T2DM for 3 months prior to Screening. This includes diet and/or exercise alone or in combination with any oral medication for T2DM treatment except for DPP-4 inhibitors. Participants can be treatment naïve if they have an HbA1c of 6.5% to 7.5%, inclusive.
- •BMI ≥27 kg/m^
- •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 type 1 diabetes mellitus (T1DM) or any other type of diabetes except T2DM.
- •History of diabetic ketoacidosis or hyperosmolar state/coma within 1 year prior to Screening.
- •History of severe hypoglycemia or hypoglycemia unawareness within 1 year 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 gastrointestinal (GI) motility if taken for >30 days continually within 3 months prior to Screening.
- •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, GLP-1 receptor agonists, GLP-1/glucose-dependent insulinotropic polypeptide (GIP) agonists, glucagon receptor agonists, or other weight loss medications or treatments aside from diet and exercise within 3 months prior to Screening.
- •Note: Additional inclusion/exclusion criteria may apply, per protocol.
研究组 & 干预措施
Ribupatide: Dose 2
Experimental
Participants will receive Dose 2 of ribupatide once weekly.
干预措施: Ribupatide (Drug)
Ribupatide: Dose 3
Experimental
Participants will receive Dose 3 of ribupatide once weekly.
干预措施: Ribupatide (Drug)
Placebo
Placebo Comparator
Participants will receive placebo matched to ribupatide once weekly.
干预措施: Placebo (Drug)
Ribupatide: Dose 1
Experimental
Participants will receive Dose 1 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)
结局指标
主要结局
Doses 3 and 4 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76
时间窗: Baseline, Week 76
Doses 3 and 4 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76
时间窗: Baseline, Week 76
Doses 3 and 4 KAI-9531 Versus Placebo: Percent Change From Baseline in Body Weight at Week 76
时间窗: Baseline, Week 76
Doses 3 and 4 KAI-9531 Versus Placebo: Change From Baseline in HbA1c at Week 76
时间窗: Baseline, Week 76
次要结局
- Doses 1 and 2 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76(Baseline, Week 76)
- Doses 1 and 2 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76(Baseline, Week 76)
- Percentage of Participants with HbA1c <7% and ≤6.5%(Baseline, Week 76)
- Plasma Concentrations of Ribupatide(Up to Week 76)
- Change From Baseline in CoEQ Hunger Score(Baseline, Week 76)
- Change From Baseline in CoEQ Satiety Score(Baseline, Week 76)
- Percent Change From Baseline in Fasting Low-density Lipoprotein (LDL)-cholesterol(Baseline, Week 76)
- Change From Baseline in CoEQ Positive Mood Score(Baseline, Week 76)
- Change From Baseline in CoEQ Craving for Sweets Score(Baseline, Week 76)
- Percent Change From Baseline in Very Low-density Lipoprotein (VLDL)-cholesterol(Baseline, Week 76)
- Percent Change From Baseline in Fasting Insulin(Baseline, Week 76)
- Change From Baseline in CoEQ Craving for Savory Food Score(Baseline, Week 76)
- Change From Baseline in Control of Eating Questionnaire (CoEQ) Craving Control Score(Baseline, Week 76)
- Change From Baseline in CoEQ Combined Score(Baseline, Week 76)
- Percentage of Participants with ≥30% Reduction in Body Weight(Baseline, Week 76)
- Change From Baseline in BMI(Baseline, Week 76)
- Percentage of Participants with HbA1c <5.7%(Baseline, Week 76)
- Change From Baseline in Diastolic Blood Pressure (DBP)(Baseline, Week 76)
- Percent Change From Baseline in Fasting Total Cholesterol(Baseline, Week 76)
- Doses 1 and 2 KAI-9531 Versus Placebo: Percent Change From Baseline in Body Weight at Week 76(Baseline, Week)
- Doses 1 and 2 KAI-9531 Versus Placebo: Change From Baseline in HbA1c at Week 76(Baseline, Week 76)
- Percentage of Participants with ≥5%, ≥10%, ≥15%, ≥20% and ≥25% Reduction in Body Weight(Baseline, Week 76)
- Change From Baseline in Waist Circumference(Baseline, Week 76)
- Change From Baseline in Absolute Body Weight(Baseline, Week 76)
- Percentage of Participants with HbA1c <7% and ≤6.5%(Baseline, Week 760)
- Change From Baseline in Fasting Blood Glucose(Baseline, Week 76)
- Change From Baseline in Systolic Blood Pressure (SBP)(Baseline, Week 76)
- Percent Change From Baseline in Fasting Triglycerides(Baseline, Week 76)
- Percent Change From Baseline in Fasting High-density Lipoprotein (HDL)-cholesterol(Baseline, Week 76)
- Percent Change From Baseline in Fasting Non-HDL-cholesterol(Baseline, Week 76)
- Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score(Baseline, Week 76)
- Participants with Body Mass Index (BMI) ≥35 Kilograms per Square Meter (kg/m^2): Percent Change From Baseline in Body Weight(Baseline, Week 76)
- Change From Baseline in Food Noise Questionnaire (FNQ) Score(Baseline, Week 76)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(Day 1 up to Week 80)
- Number of Participants With Anti-drug Antibodies (ADAs)(Up to Week 80)
- Number of Participants With Neutralizing Antibodies (Nabs)(Up to Week 80)
- Plasma Concentrations of KAI-9531(Up to Week 76)
研究者
研究点 (175)
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