NCT07670416招募中3 期
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 in Adult Chinese Patients With Obesity or Overweight, With or Without Type 2 Diabetes Mellitus
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 22
- 主要终点
- Percent Change From Baseline in Body Weight at Week 52
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA) being developed for chronic weight management, as an adjunct to a reduced-calorie diet and increased physical activity in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity, and in participants with T2DM who have obesity or overweight.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) ≥24.0 kilograms per meter squared (kg/m^2) for participants with type 2 diabetes mellitus (T2DM)
- •BMI ≥28.0 kg/m^2 or BMI ≥24.0 and <28.0 kg/m^2 and diagnosed with at least one weight-related comorbidity (prediabetes, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea, or weight-related cardiovascular disease) for participants without T2DM
- •Agreement to adhere to the contraception requirements
排除标准
- •History of Type 1 diabetes mellitus (T1DM)
- •Obesity induced by other endocrinologic disorders
- •Any planned major medical procedure or surgery during the study
- •History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder
- •Any lifetime history of suicide attempt
- •History of any hematologic conditions that may interfere with HbA1c measurement
- •History of acute or chronic pancreatitis or clinically significant gallbladder disease
- •Treatment with any approved or investigational GLP-1-RA-based therapy within 6 months prior to randomization
- •Treatment with other investigational therapy within 3 months prior to randomization or less than 5 elimination half-lives prior to randomization, whichever is longer
- •Known allergy to any component of the study drug formulation or any other condition that is a contraindication to GLP-1 RAs or GLP-1/GIP RAs
研究组 & 干预措施
Enicepatide Dose 1
Experimental
Participants will receive enicepatide Dose 1.
干预措施: Enicepatide (Combination Product)
Enicepatide Dose 3
Experimental
Participants will receive enicepatide Dose 3.
干预措施: Enicepatide (Combination Product)
Enicepatide Dose 2
Experimental
Participants will receive enicepatide Dose 2.
干预措施: Enicepatide (Combination Product)
Placebo
Placebo Comparator
Participants will receive matching placebo.
干预措施: Placebo (Combination Product)
结局指标
主要结局
Percent Change From Baseline in Body Weight at Week 52
时间窗: Baseline through Week 52
次要结局
- Change From Baseline in Body Weight at Week 52(Baseline through Week 52)
- Change From Baseline in Waist Circumference at Week 52(Baseline through Week 52)
- Change From Baseline in Fasting Glucose at Week 52(Baseline through Week 52)
- Change From Baseline in Fasting Insulin at Week 52(Baseline through Week 52)
- Percentage of Participants Achieving ≥20% Body Weight Loss, in Participants Receiving Enicepatide Dose 2 and Dose 3(At Week 52)
- Percentage of Participants Achieving ≥5% Body Weight Loss at Week 52(At Week 52)
- Percentage of Participants Achieving ≥10% Body Weight Loss at Week 52(At Week 52)
- Percentage of Participants Achieving ≥15% Body Weight Loss at Week 52(At Week 52)
- Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol at Week 52(Baseline through Week 52)
- Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 52(Baseline through Week 52)
- Change From Baseline in Triglyceride at Week 52(Baseline through Week 52)
- Change From Baseline in Systolic Blood Pressure at Week 52(Baseline through Week 52)
- Change From Baseline in the Physical Functioning as Assessed by Short Form 36 Health Survey Acute, Version 2.0 (SF-36 v2 Acute) at Week 52(Baseline through Week 52)
- Change From Baseline in Physical Functioning Composite Score as Assessed by Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQoL-Lite-CT) Questionnaire at Week 52(Baseline through Week 52)
- Percent Change From Baseline in Body Weight at Week 52 in GLP-1 RA-based Treatment Naive Populations(Baseline through Week 52)
- Change From Baseline in Waist-to-Hip Ratio at Week 52(Baseline through Week 52)
- Change From Baseline in Waist-to-Height Ratio at Week 52(Baseline through Week 52)
- Percentage of Participants With Prediabetes at Baseline Achieving Normoglycemia (Hemoglobin A1c [HbA1c] <5.7%) at Week 52(At Week 52)
- Change From Baseline in Health Related Quality of Life (HRQoL) as Assessed by the SF-36v2 Acute Domain Scores and Component Summary Scores at Week 52(Baseline through Week 52)
- Change From Baseline in HRQoL as Assessed by the IWQoL-Lite-CT Questionnaire Domain Scores and Total Score at Week 52(Baseline through Week 52)
- Change From Baseline in Non-HDL Cholesterol at Week 52(Baseline through Week 52)
- Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 52(Baseline through Week 52)
- Change From Baseline in Total Cholesterol at Week 52(Baseline through Week 52)
- Change From Baseline in Free Fatty Acids at Week 52(Baseline through Week 52)
- Change From Baseline in Diastolic Blood Pressure at Week 52(Baseline through Week 52)
- Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 52(Baseline through Week 52)
- Change From Baseline in Serum Uric Acid at Week 52(Baseline through Week 52)
- Percentage of Participants Achieving ≥25% Body Weight Loss at Week 52, in Participants Receiving Enicepatide Dose 2 and Dose 3(Baseline through Week 52)
- Change From Baseline in Body Mass Index (BMI) at Week 52(Baseline through Week 52)
- Percent Change From Baseline in Body Weight by Obesity Class at Week 52(Baseline through Week 52)
- Change From Baseline in HbA1c at Week 52 in Participants With T2DM(Baseline through Week 52)
- Percentage of Participants With T2DM Achieving HbA1c of <5.7%, ≤6.5% and <7% at Week 52(At Week 52)
- Change From Baseline in Total Lean Tissue Volume at Week 52(Baseline through Week 52)
- Percent Change From Baseline in Total Lean Tissue Volume at Week 52(Baseline through Week 52)
- Change From Baseline in Total Adipose Tissue Volume at Week 52(Baseline through Week 52)
- Percent Change From Baseline in Total Adipose Tissue Volume at Week 52(Baseline through Week 52)
- Incidence and Severity of Adverse Events, With Severity Determined According to Mild, Moderate, and Severe Criteria(Baseline to Safety Follow-Up (55 Weeks))
- Change From Baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS) Score(Baseline through Week 52)
- Change From Baseline in the Patient Health Questionnaire-9 (PHQ-9) Score(Baseline through Week 52)
研究者
研究点 (22)
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