2025-523510-87-00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 and Diabetes
Kailera Therapeutics Inc.77 个研究点 分布在 5 个国家目标入组 400 人开始时间: 2026年6月25日最近更新:
适应症
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
- 400
- 试验地点
- 77
- 主要终点
- Percent change in body weight (kg) from baseline at Week 76. Change in hemoglobin A1c (%) from baseline at Week 76
研究概览
简要总结
To demonstrate ribupatide SC QW is superior to placebo on percent change in body weight and change in hemoglobin A1c (HbA1c)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of 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 glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1R/glucosedependent insulinotropic polypeptide receptor (GIPR) dual agonist, or DPP-4 inhibitors. Participants can be treatment naïve if they have an HbA1c of 6.5% to 7.5%, inclusive.
- •BMI ≥27 kg/m2
- •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 T1DM or any other type of diabetes except T2DM.
- •History of suicide attempt.
- •History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder (eg, schizophrenia, bipolar disorder, or other serious mood or anxiety 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.
- •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 (eg, severe gastroparesis, gastric outlet obstruction, or inflammatory bowel disease/irritable bowel syndrome) or chronic treatment with medications that directly affect GI motility if taken for >30 days continually within 3 months prior to Screening.
研究组 & 干预措施
KAI-9531, KAI-9531, KAI-9531
Test
干预措施: KAI-9531 (Drug)
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)
结局指标
主要结局
Percent change in body weight (kg) from baseline at Week 76. Change in hemoglobin A1c (%) from baseline at Week 76
Percent change in body weight (kg) from baseline at Week 76. Change in hemoglobin A1c (%) from baseline at Week 76
次要结局
- Controlled for Type I error Percent change in body weight (kg) from baseline at Week 76
- Controlled for Type I error Change in hemoglobin A1c (%) 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 weight (kg) • Percentage of participants with HbA1c <7% and ≤6.5% • Change in fasting blood glucose (mg/dL • Change in SBP (mm Hg) • Percent change in fasting: − Triglycerides (mg/dL) − HDL-cholesterol (mg/dL) − Non-HDL-cholesterol (mg/dL) • Change in IWQOL-Lite-CT physical function composite score
- Controlled for Type I error: Percent change in body weight (kg) from baseline at Week 76 in subgroup of participants with BMI ≥35 kg/m2
- Not controlled for Type I error:From baseline at Week 76:Percentage of participants with ≥30% reduction in body weight (kg).Change in BMI (kg/m2).Percentage of participants with HbA1c <5.7%.Change in DBP (mm Hg).Percent change in fasting:Total cholesterol (mg/dL)−LDL-cholesterol (mg/dL)−VLDL-cholesterol (mg/dL)−insulin (mIU/L).Change in Control of Eating Questionnaire (COEQ).Change (all KAI-9531 doses combined) in Food Noise Questionnaire (FNQ) score
- Not controlled for Type I error: • Treatment-emergent adverse events (TEAEs)
- Not controlled for Type I error: • Antidrug antibodies (ADAs) • Neutralizing antibodies (NAbs)
- Not controlled for Type I error: Concentrations of KAI-9531
- Not controlled for Type I error:From baseline at Week 76:Percentage of participants with ≥30% reduction in body weight (kg).Change in BMI (kg/m2).Percentage of participants with HbA1c <5.7%.Change in DBP (mm Hg).Percent change in fasting:Total cholesterol (mg/dL)−LDL-cholesterol (mg/dL)−VLDL-cholesterol (mg/dL)−insulin (mIU/L).Change in Control of Eating Questionnaire (COEQ).Change (all ribupamide doses combined) in Food Noise Questionnaire (FNQ) score
- Not controlled for Type I error: Concentrations of ribupamide
研究者
Kailera Therapeutics, Inc
Scientific
Kailera Therapeutics Inc.
研究点 (77)
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