NCT07843498尚未招募3 期
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once Weekly Petrelintide vs. Placebo in Participants With Overweight or Obesity
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 3,900
- 主要终点
- Percentage Change in Body Weight from Baseline
研究概览
简要总结
This study will evaluate the efficacy and safety of petrelintide compared with placebo, in conjunction with a reduced-calorie diet and increased physical activity, for weight management in participants living with overweight or obesity, at least one weight-related comorbidity, and without Type 2 Diabetes (T2D).
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 四盲 (受试者、医护人员、研究者、结局评估者)
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
- Participants with BMI ≥ 30 kg/m² or BMI ≥ 27 kg/m² with at least one weight-related comorbidity
- History of at least one self-reported unsuccessful dietary effort to lose body weight
排除标准
- HbA1c ≥ 48 mmol/mol (6.5%), measured by the central laboratory at screening
- Known history of Type 1 or Type 2 diabetes mellitus
- Current or previous treatment with petrelintide or any other amylin analog
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Combination Product)
Petrelintide
Experimental
干预措施: Petrelintide (Combination Product)
结局指标
主要结局
Percentage Change in Body Weight from Baseline
时间窗: From Baseline to Week 64
次要结局
- Change from Baseline in Body Weight (kg)(From Baseline to Week 64)
- Change from Baseline in High-Density Lipoprotein (HDL) Cholesterol(From Baseline to Week 64)
- Change from Baseline in Waist-to-Hip Ratio(From Baseline to Week 64)
- Change from Baseline in Waist-to-Height Ratio(From Baseline to Week 64)
- Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQoL-Lite-CT) Physical Functioning Composite Score(From Baseline to Week 64)
- Change from Baseline in Fasting Insulin(From Baseline to Week 64)
- Change from Baseline in SF-36v2 Acute Form Physical Functioning Domain Score in Participants with Poor Physical Functioning at Baseline (as defined by PGI-S)(From Baseline to Week 64)
- Change from Baseline in Mean Daily Food Craving Score(From Baseline to Week 64)
- Change from Baseline in IWQoL-Lite-CT Physical Functioning Composite Score in Participants with Poor Physical Functioning at Baseline (as defined by Patient Global Impression of Severity/Status [PGI-S])(From Baseline to Week 64)
- Change from Baseline in Short Form (36) Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score(From Baseline to Week 64)
- Change from Baseline in Mean Daily Peak Hunger Score(From Baseline to Week 64)
- Change from Baseline in Body Mass Index (BMI) (kg/m²)(From Baseline to Week 64)
- Change from Baseline in Triglycerides(From Baseline to Week 64)
- Proportion of Participants Achieving ≥ 5% Body Weight Loss from Baseline(From Baseline to Week 64)
- Proportion of Participants Achieving ≥ 10% Body Weight Loss from Baseline(From Baseline to Week 64)
- Proportion of Participants Achieving ≥ 15% Body Weight Loss from Baseline(From Baseline to Week 64)
- Change from Baseline in Waist Circumference (cm)(From Baseline to Week 64)
- Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)(From Baseline to Week 64)
- Change from Baseline in Fasting Glucose(From Baseline to Week 64)
- Change from Baseline in Hemoglobin A1c (HbA1c)(From Baseline to Week 64)
- Percentage of Participants Achieving HbA1c of <5.7%(At Week 64)
- Change from Baseline in Very-Low-Density Lipoprotein (VLDL) Cholesterol(From Baseline to Week 64)
- Change from Baseline in Non-HDL Cholesterol(From Baseline to Week 64)
- Change from Baseline in Total Cholesterol(From Baseline to Week 64)
- Change from Baseline in Low-Density Lipoprotein (LDL) Cholesterol(From Baseline to Week 64)
- Change from Baseline in Free Fatty Acids(From Baseline to Week 64)
- Change from Baseline in Systolic Blood Pressure(From Baseline to Week 64)
- Change from Baseline in Diastolic Blood Pressure(From Baseline to Week 64)
- Change from Baseline in Health-Related Quality of Life (HRQoL) as assessed by SF-36v2 Acute Form Domain Scores and Component Summary Scores(From Baseline to Week 64)
- Change from Baseline in HRQoL as assessed by IWQoL-Lite-CT Domain Scores and Total Score(From Baseline to Week 64)
- Proportion of Participants with ≥ 14.6-Point Increase from Baseline in IWQoL-Lite-CT Physical Function Score(From Baseline to Week 64)
- Proportion of Participants with ≥ 3.7-Point Increase from Baseline in SF36v2 Physical Functioning Score(From Baseline to Week 64)
- Proportion of Participants with Baseline Poor Physical Functioning Achieving ≥ 14.6-Point Increase in IWQoL-Lite-CT Physical Functioning Score(From Baseline to Week 64)
- Proportion of Participants with Baseline Poor Physical Functioning Achieving a ≥ 3.7-Point Increase in SF36v2 Physical Functioning Score(From Baseline to Week 64)
- Change from Baseline in Mean Daily Average Hunger Score(From Baseline to Week 64)
- Change from Baseline in Mean Daily Average Satiety Score(From Baseline to Week 64)
- Change from Baseline in Mean Daily Average Appetite Score(From Baseline to Week 64)
- Incidence and Severity of Adverse Events, with Severity Determined According to Mild/Moderate/Severe Criteria(From Baseline to Week 64)
- Percentage of Participants with Baseline Anti-Drug Antibodies (ADAs) and Treatment-Emergent ADAs Against Petrelintide(From Baseline to Week 64)
- Change from Baseline in Total Fat Mass(From Baseline to Week 64)
- Change from Baseline in Total Lean Mass(From Baseline to Week 64)
研究者
标识符
- NCT 编号
- NCT07843498
- 其他研究编号
- CC46368, 2026-526188-39-00
日期
- 首次提交
- (19天前)
- 首次发布
- (前天)
- 主要完成日期
- (2年后)
- 研究完成日期
- (2年后)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 是
- FDA 监管器械
- 否
- 是否有结果
- 否
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