NCT07652047招募中1 期
A Phase 1b Study Investigating Safety, Pharmacokinetics, and Pharmacodynamics of CX11 Tablets in Participants With Obesity or Overweight With Weight-Related Comorbidities
Corxel Pharmaceuticals2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年5月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Percentage change in body weight from baseline
研究概览
简要总结
A multi-center, randomized, placebo-controlled, double-blinded (within cohorts), Sponsor-unblinded, Phase 1b study to explore the safety, pharmacokinetics, and pharmacodynamics of CX11 tablets in participants with obesity or overweight with weight-related comorbidities.
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18-55 years.
- •BMI ≥30.0 to ≤39.9 kg/m², or ≥27.0 to <30.0 kg/m² with at least 1 weight-related comorbidity: prediabetes, hypertension, dyslipidemia, or obstructive sleep apnea.
- •Prior unsuccessful diet/exercise weight-loss attempt and stable body weight within 90 days.
- •Able to comply with study procedures and reproductive requirements.
排除标准
- •Diabetes or obesity due to endocrine/genetic causes.
- •Recent weight-loss drugs, GLP-1-based therapy, glucose-lowering drugs, obesity surgery/device, or investigational treatment.
- •Significant cardiovascular, ECG/QT, pancreatic, gallbladder, GI, liver, kidney, thyroid, psychiatric, malignant, infectious, autoimmune, or lab abnormality risks.
- •Personal/family history of medullary thyroid carcinoma or multiple endocrine neoplasia.
- •Pregnancy, breastfeeding, recent nicotine/drug use, excessive alcohol use, or any condition/medication making participation inappropriate.
研究组 & 干预措施
Placebo group
Placebo Comparator
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Percentage change in body weight from baseline
时间窗: Week 26
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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