NCT07497880进行中（未招募）2 期
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity
Kailera72 个研究点 分布在 2 个国家目标入组 306 人开始时间: 2026年4月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 306
- 试验地点
- 72
- 主要终点
- Percent Change from Baseline in Body Weight at Week 44 for Participants Without Diabetes Mellitus
研究概览
简要总结
The primary objective of this study is to determine the efficacy of oral KAI-7535 once daily compared with placebo on percent change in body weight in participants living with obesity or overweight, with at least 1 weight-related comorbidity, without diabetes mellitus. Safety and tolerability and other weight-related outcomes will also be evaluated.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For participants without diabetes mellitus at screening and on Day 1, BMI ≥30 kilograms/square meter (kg/m^2) or BMI ≥27 kg/m^2 and a previous diagnosis of at least 1 of the following:
- •Hypertension
- •Dyslipidemia
- •Obstructive sleep apnea
- •Cardiovascular disease
- •For participants living with type 2 diabetes mellitus and BMI ≥27 kg/m^2 only:
- •Diagnosis of type 2 diabetes mellitus
- •On stable therapy for type 2 diabetes mellitus for at least 3 months prior to screening
排除标准
- •For participants without diabetes:
- •Laboratory evidence of diabetes
- •Taking a concomitant medication for the indication of glycemic control
- •For participants living with type 2 diabetes mellitus only:
- •History of diabetic ketoacidosis or hyperosmolar state/coma within 1 year of screening
- •History of severe hypoglycemia or hypoglycemia unawareness within 1 year of screening
- •History of proliferative diabetic retinopathy, diabetic maculopathy, or nonproliferative diabetic retinopathy that required acute treatment
- •Started medications that may cause significant weight change within 3 months prior to screening, including 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 carcinoma
- •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 or other severe psychiatric disorder
- •Received treatment with semaglutide, tirzepatide, glucagon-like peptide-1 (GLP-1) receptor agonist, GLP-1/glucose-dependent insulinotropic polypeptide receptor agonist, or glucagon receptor agonist within the last 3 months prior to screening
- •Note: Additional inclusion/exclusion criteria may apply, per protocol.
研究组 & 干预措施
KAI-7535: Dose Schedule 1
Experimental
Participants will receive KAI-7535 once daily.
干预措施: KAI-7535 (Drug)
Placebo
Placebo Comparator
Participants will receive placebo matched to KAI-7535 once daily.
干预措施: Placebo (Drug)
KAI-7535: Dose Schedule 3
Experimental
Participants will receive KAI-7535 once daily.
干预措施: KAI-7535 (Drug)
KAI-7535: Dose Schedule 4
Experimental
Participants will receive KAI-7535 once daily.
干预措施: KAI-7535 (Drug)
KAI-7535: Dose Schedule 2
Experimental
Participants will receive KAI-7535 once daily.
干预措施: KAI-7535 (Drug)
结局指标
主要结局
Percent Change from Baseline in Body Weight at Week 44 for Participants Without Diabetes Mellitus
时间窗: Baseline, Week 44
次要结局
- Percent Change from Baseline in Body Weight at Week 44 for Participants Living with Type 2 Diabetes Mellitus(Baseline, Week 44)
- Percentage of Participants at Week 44 with ≥5% and ≥10% Reduction in Body Weight for Participants Without Diabetes Mellitus(Week 44)
- Change from Baseline in Body Weight at Week 44 for Participants Without Diabetes Mellitus(Baseline, Week 44)
- Change from Baseline in Body Mass Index (BMI) at Week 44 for Participants Without Diabetes Mellitus(Baseline, Week 44)
- Change from Baseline in Body Weight at Week 44 for Participants Living with Type 2 Diabetes Mellitus(Baseline, Week 44)
- Change from Baseline in BMI at Week 44 for Participants Living with Type 2 Diabetes Mellitus(Baseline, Week 44)
- Percentage of Participants at Week 44 with ≥5% and ≥10% Reduction in Body Weight for Participants Living with Type 2 Diabetes Mellitus(Week 44)
- Change from Baseline in Body Weight at Week 44(Baseline, Week 44)
- Change from Baseline in Body Mass Index (BMI) at Week 44(Baseline, Week 44)
- Percentage of Participants at Week 44 with ≥5% and ≥10% Reduction in Body Weight(Week 44)
- Change from Baseline in Waist Circumference at Week 44(Baseline, Week 44)
研究者
研究点 (72)
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