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临床试验/NCT07843485
NCT07843485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 and Type 2 Diabetes

Hoffmann-La Roche0 个研究点目标入组 600 人开始时间: 2026年9月30日最近更新:
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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
600
主要终点
Percentage Change in Body Weight from Baseline
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

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 and with 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 ≥ 27 kg/m²
  • T2D diagnosis as per World Health Organization (WHO) classification (or other locally applicable standards) with HbA1c ≥ 6.5% to ≤ 10% (48-86 mmol/mol), measured by the central laboratory at screening
  • Stable treatment with either diet and exercise alone, basal insulin, or selected oral glucose-lowering agents, for at least 90 days prior to and during screening
  • History of at least one self-reported unsuccessful dietary effort to lose body weight

排除标准

  • History or presence of proliferative diabetic retinopathy, or diabetic macular edema
  • 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

  • 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 Hemoglobin A1c (HbA1c)(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 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 Food Craving Score(From Baseline to Week 64)
  • Change from Baseline in Mean Daily Peak Hunger Score(From Baseline to Week 64)
  • Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)(From Baseline to Week 64)
  • Change from Baseline in Body Mass Index (BMI) (kg/m²)(From Baseline to Week 64)
  • Change from Baseline in Body Weight (kg)(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 Fasting Insulin(From Baseline to Week 64)
  • Change from Baseline in Fasting Glucose(From Baseline to Week 64)
  • Percentage of Participants Achieving HbA1c of < 5.7%(At Week 64)
  • Percentage of Participants Achieving HbA1c of < 6.5%(At Week 64)
  • Percentage of Participants Achieving HbA1c of < 7%(At Week 64)
  • Change from Baseline in High-Density Lipoprotein (HDL) Cholesterol(From Baseline to Week 64)
  • Change from Baseline in Triglycerides(From Baseline to 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 Functioning 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)
  • 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 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)
  • 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)

研究者

申办方类型
企业
责任方
申办方

标识符

NCT 编号
NCT07843485
其他研究编号
CC46369, 2026-526189-25-00

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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