NCT07353931招募中3 期
A Master Protocol for Phase 3 Randomized, Double-Blind, Placebo-Controlled Studies to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Osteoarthritis Knee Pain, and Obesity or Overweight (ENLIGHTEN-4)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 900
- 试验地点
- 190
- 主要终点
- Percent Change from Baseline in Body Weight
研究概览
简要总结
The YDAN master protocol will support two independent studies, J3R-MC-YOA1 and J3R-MC-YOA2. Each study will investigate how well and safely Eloralintide (LY3841136) works in adults with obesity or overweight who have osteoarthritis (OA) of the knee with pain. Participation in the study will last about 75 weeks, including screening.
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
- •Have a body mass index (BMI) of 27 kilograms per square meter (kg/m²) or higher at screening
- •Have a stable body weight (less than 5% body weight change) for 90 days prior to screening
- •Have tried at least once to lose weight through diet but were unsuccessful
- •Have osteoarthritis of the knee and at least one of the following conditions:
- •Be over 50 years old
- •Have morning knee stiffness that lasts about 30 minutes
- •Have a crackling or grinding sound or feeling in the knee
排除标准
- •Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed greater than 1 year before screening)
- •Have a prior or planned endoscopic procedure and/or device-based therapy for obesity (prior device-based therapy acceptable if device removal was more than 6 months prior to screening)
- •Have type 1 diabetes, type 2 diabetes, or any other type of diabetes
- •Have an active knee infection
- •Have had within 90 days prior to screening:
- •heart attack
- •coronary artery revascularization
- •unstable angina, or
- •hospitalization due to congestive heart failure
- •Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive heart failure
- •Have taken medications or alternative remedies intended for weight loss within 90 days of screening
研究组 & 干预措施
Placebo (YOA1)
Placebo Comparator
Participants will receive placebo SC
干预措施: Placebo (Drug)
Placebo (YOA2)
Placebo Comparator
Participants will receive placebo SC
干预措施: Placebo (Drug)
Eloralintide (YOA1)
Experimental
Participants will receive eloralintide subcutaneously (SC)
干预措施: Eloralintide (Drug)
Eloralintide (YOA2)
Experimental
Participants will receive eloralintide SC
干预措施: Eloralintide (Drug)
结局指标
主要结局
Percent Change from Baseline in Body Weight
时间窗: Baseline, Week 64
Percent Change from Baseline in Body Weight
Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
时间窗: Baseline, Week 64
Change from Baseline in the WOMAC Pain Subscale Score
次要结局
- Change from Baseline in Systolic Blood Pressure (SBP)(Baseline, Week 64)
- Percent Change from Baseline in Triglycerides(Baseline, Week 64)
- Change from Baseline in Short Form-36 (SF-36 v2) Acute Form Physical Functioning Domain Score(Baseline, Week 64)
- Percent Change from Baseline in High Sensitivity, C-reactive Protein (hsCRP)(Baseline, Week 64)
- Change from Baseline in the WOMAC Physical Function Subscale Score(Baseline, Week 40, Week 64)
- Change from Baseline WOMAC Pain Subscale Score(Baseline, Week 40)
- Change from Baseline in Distance Walked During the 6-Minute Walk Test(Baseline, Week 64)
- Change from Baseline in Body Mass Index (BMI)(Baseline, Week 64)
- Change in Medication Use(Baseline, Week 64)
- Change from Baseline in SF-36v2 Acute Form Domain Scores With Exception of the Physical Functioning Domain Score(Baseline, Week 64)
- Change from Baseline in Health Status EQ-5D-5L Health State Utility(Baseline, Week 64)
- Percent Change from Baseline in Fasting Insulin(Baseline, Week 64)
- Percent Change from Baseline in Total Cholesterol(Baseline, Week 64)
- Change from Baseline in Waist Circumference(Baseline, Week 64)
- Percent Change from Baseline in Hemoglobin A1c (HbA1c)(Baseline, Week 64)
- Change from Baseline in WOMAC Stiffness Subscale Score(Baseline, Week 64)
- Change from Baseline in WOMAC Total Score(Baseline, Week 64)
- Achievement of Improved Categorical Shift in Patient Global Impression of Severity (PGIS) - Target Knee Pain(Baseline, Week 64)
- Achievement of Improved Categorical Shift in Patient Global Impression of Severity (PGIS) - Target Knee Function(Baseline, Week 64)
- Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS) Score(Baseline, Week 64)
- Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS) Score(Baseline, Week 64)
- Pharmacokinetics (PK): Maximum Concentration at Steady State (Cmax, ss)(Baseline through Week 64)
- PK: Area Under the Concentration Versus Time Curve for One Dosing Interval at Steady State (AUC(0-T)ss)(Baseline through Week 64)
- Number of Participants with Allowed Concomitant Pain Medication(Baseline, Week 64)
研究者
研究点 (190)
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