NCT06854952已完成2 期
A Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of TERN-601 in Adults With Overweight or Obesity
Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)18 个研究点 分布在 1 个国家目标入组 167 人开始时间: 2025年3月7日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 18
- 主要终点
- Percent Change in Body Weight
研究概览
简要总结
This is a Phase 2a multicenter, randomized, double-blind, placebo-controlled clinical trial studying the efficacy, safety, and tolerability of orally administered TERN-601 in adults with overweight or obesity.
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
- •Female or male aged 18 to 75 years
- •Body mass index (BMI) of:
- •≥ 30 kg/m^2 to < 50 kg/m^2
- •≥ 27 kg/m^2 to < 30 kg/m^2 with at least 1 weight-related comorbidity
- •HbA1c < 6.5%
- •Stable self-reported body weight for at least 3 months prior to study (< 5% body weight gain or loss)
排除标准
- •Have diabetes mellitus
- •Have obesity induced by medication or other diagnosed endocrinologic disorders
- •Have had or are planning surgical treatment or device-based therapy for obesity
- •Lifetime history of suicide attempt
研究组 & 干预措施
TERN-601 750 mg
Experimental
Orally administered once daily.
干预措施: TERN-601 (Drug)
TERN-601 250 mg
Experimental
Orally administered once daily.
干预措施: TERN-601 (Drug)
TERN-601 500 mg (slow titration)
Experimental
Orally administered once daily.
干预措施: TERN-601 (Drug)
TERN-601 500 mg
Experimental
Orally administered once daily.
干预措施: TERN-601 (Drug)
Matching Placebo
Placebo Comparator
Orally administered once daily.
干预措施: Matching Placebo (Other)
结局指标
主要结局
Percent Change in Body Weight
时间窗: 12 weeks
Percent change (%) in body weight from baseline to Week 12
次要结局
- Change in Body Weight(12 weeks)
- ≥ 5% Weight Loss(12 weeks)
- Change in Body Weight (kg)(12 weeks)
研究者
研究点 (18)
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