NCT07351058招募中3 期
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 Administered to Participants With Obesity or Overweight and Type 2 Diabetes
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,600
- 试验地点
- 210
- 主要终点
- Percent (%) Change from Baseline in Body Weight at Week 72
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), at multiple doses compared with placebo for weight management in participants with obesity or overweight and Type 2 diabetes mellitus (T2DM).
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
- •Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)
- •Diagnosis of type 2 diabetes mellitus (T2DM) according to WHO classification or other locally applicable standards with HbA1c ≥6.5% to ≤10% determined by laboratory test at screening, and on stable oral therapy for at least 3 months prior to screening (if applicable). T2DM may be treated with diet/exercise alone or any oral anti-hyperglycemic medication (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or GLP-1 RA-based therapy.
- •Body mass index (BMI) ≥27.0 kg/m^2
- •History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight
排除标准
- •History of type 1 diabetes mellitus (T1DM) or any lifetime history of ketoacidosis or history of hyperosmolar state/coma within 12 months prior to screening
- •Have had 1 or more episodes of severe hypoglycemia and/or has hypoglycemia unawareness within the 6 months prior to screening
- •At least 2 confirmed fasting blood glucose values >270 mg/dL (15.0 mmol/L) (on 2 non-consecutive days) during screening
- •Self-reported change in body weight >5 kg within 3 months prior to screening
- •Obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptor deficiency or Prader-Willi syndrome)
- •Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed.
- •Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)
- •Poorly controlled hypertension at screening
- •Have any of the following cardiovascular conditions within 3 months prior to screening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transient ischemic attack; Unstable angina; Hospitalization due to congestive heart failure
- •Treatment with any approved or investigational GLP-1-RA-based therapy (e.g., GLP-1 receptor mono agonist, GLP-1/GIP receptor dual agonist, GLP-1/GIP/Gluc receptor triple agonist) within 6 months prior to randomization
研究组 & 干预措施
Arm 1: Placebo
Placebo Comparator
干预措施: Placebo (Combination Product)
Arm 2: Enicepatide Dosing Regimen 1
Experimental
干预措施: Enicepatide (Combination Product)
Arm 3: Enicepatide Dosing Regimen 2
Experimental
干预措施: Enicepatide (Combination Product)
Arm 4: Enicepatide Dosing Regimen 3
Experimental
干预措施: Enicepatide (Combination Product)
结局指标
主要结局
Percent (%) Change from Baseline in Body Weight at Week 72
时间窗: Baseline through Week 72
次要结局
- Percentage of Participants Achieving ≥5% Body Weight Loss from Baseline at Week 72(Baseline and Week 72)
- Percentage of Participants Achieving ≥10% Body Weight Loss from Baseline at Week 72(Baseline and Week 72)
- Percentage of Participants Achieving ≥15% Body Weight Loss from Baseline at Week 72(Baseline and Week 72)
- Change from Baseline in Body Weight (kg) at Week 72(Baseline through Week 72)
- Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72(Baseline through Week 72)
- Percentage of Participants Achieving HbA1c of ≤6.5% at Week 72(Week 72)
- Percentage of Participants Achieving HbA1c of <7% at Week 72(Week 72)
- Change from Baseline in Waist Circumference (cm) at Week 72(Baseline through Week 72)
- Change from Baseline in Fasting Glucose at Week 72(Baseline through Week 72)
- Change from Baseline in Fasting Insulin at Week 72(Baseline through Week 72)
- Change from Baseline in Low-Density Lipoprotein (LDL) Cholesterol at Week 72(Baseline through Week 72)
- Change from Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 72(Baseline through Week 72)
- Change from Baseline in Triglyceride at Week 72(Baseline through Week 72)
- Change from Baseline in Systolic Blood Pressure at Week 72(Baseline through Week 72)
- Change from Baseline in the Physical Functioning Domain Score of the Short Form (36) Health Survey Version 2 (SF-36v2) Acute Form at Week 72(Baseline through Week 72)
- Change from Baseline in Physical Functioning Composite Score of the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQoL-Lite-CT) Questionnaire at Week 72(Baseline through Week 72)
- Change from Baseline in Waist-to-Hip Ratio at Week 72(Baseline through Week 72)
- Change from Baseline in Waist-to-Height Ratio at Week 72(Baseline through Week 72)
- Change from Baseline in Subscale Scores of the Control of Eating Questionnaire (CoEQ) at Week 72(Baseline through Week 72)
- Change from Baseline in Symptoms and Impact of Urinary Incontinence as Assessed by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) at Week 72(Baseline through Week 72)
- Percentage of Participants Experiencing No Change, Improvement, or Worsening on the Patient Global Impression of Change (PGI-C) Urinary Incontinence Questionnaire at Week 72(Baseline and Week 72)
- Percentage of Participants Experiencing No Change, Improvement, or Worsening on the Patient Global Impression of Severity (PGI-S) Urinary Incontinence Questionnaire at Week 72(Baseline and Week 72)
- Percentage of Participants Experiencing No Change, Improvement, or Worsening on the PGI-C Physical Functioning Questionnaire at Week 72(Baseline and Week 72)
- Percentage of Participants Experiencing No Change, Improvement, or Worsening on the PGI-S Physical Functioning Questionnaire at Week 72(Baseline and Week 72)
- Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the SF-36v2 Acute Form Domain Scores and Component Summary Scores at Week 72(Baseline through Week 72)
- Change from Baseline in HRQoL as Assessed by the IWQoL-Lite-CT Domain Scores and Total Score at Week 72(Baseline through Week 72)
- Change from Baseline in Non-HDL Cholesterol at Week 72(Baseline through Week 72)
- Change from Baseline in VLDL Cholesterol at Week 72(Baseline through Week 72)
- Change from Baseline in Total Cholesterol at Week 72(Baseline through Week 72)
- Change from Baseline in Free Fatty Acids at Week 72(Baseline through Week 72)
- Change from Baseline in Diastolic Blood Pressure at Week 72(Baseline through Week 72)
- Change from Baseline in High-Sensitivity C-reactive Protein (hsCRP) at Week 72(Baseline through Week 72)
- Change from Baseline in Urinary Albumin/Creatinine Ratio at Week 72(Baseline through Week 72)
- Change from Baseline in Body Mass Index (BMI) at Week 72(Baseline through Week 72)
- Percent (%) Change from Baseline in Body Weight by Obesity Class at Week 72(Baseline through Week 72)
- Time to Achieve ≥5%, ≥10%, or ≥15% Body Weight Loss from Baseline Through Week 72(From Baseline through Week 72)
- Percentage of Participants Achieving HbA1c of <5.7% at Week 72(Week 72)
- Incidence and Severity of Adverse Events, with Severity Determined According to Mild/Moderate/Severe Criteria(Baseline through Week 72)
- Change from Baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS) Score Through Week 72(Baseline through Week 72)
- Change from Baseline in the Patient Health Questionnaire-9 (PHQ-9) Score Through Week 72(Baseline through Week 72)
研究者
研究点 (210)
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