NCT07153471招募中3 期
A Phase 3 Study to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee: A Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 173
- 主要终点
- Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
研究概览
简要总结
The GZPT master protocol will support two independent studies, J2A-MC-GZT1 and J2A-MC-GZT2. Each study will see how well and safely orforglipron works in people with obesity or overweight who have osteoarthritis (OA) of the knee with pain. Participation in the study will last about 74 weeks.
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
- Single (Participant)
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 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 gained or lost more than 11 pounds within 90 days prior to screening
- •Have had a surgery for obesity or plan to have one in the next 18 months
- •Have an active knee infection
- •Have type 1 diabetes, type 2 diabetes, or any other type of diabetes
- •Have had a recent heart condition or New York Heart Association Functional Classification Class IV congestive heart failure
- •Have used any glucagon-like peptide-1 (GLP-1) receptor agonist medication within 180 days of screening
研究组 & 干预措施
Placebo (GZT1)
Placebo Comparator
Participants will receive placebo orally
干预措施: Placebo (Drug)
Orforglipron (GZT1)
Experimental
Participants will receive orforglipron orally
干预措施: Orforglipron (Drug)
Orforglipron (GZT2)
Experimental
Participants will receive orforglipron orally
干预措施: Orforglipron (Drug)
Placebo (GZT2)
Placebo Comparator
Participants will receive placebo orally
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
时间窗: Baseline, Week 72
Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
时间窗: Baseline, Week 72
次要结局
- Change from Baseline in the WOMAC Physical Function Subscale Score(Baseline, Week 72)
- Percent Change from Baseline in Body Weight(Baseline, Week 72)
- Change from Baseline in 36-item, Short-Form Health Survey, version 2 (SF-36v2) Acute Form Physical Functioning Domain Score(Baseline, Week 72)
- Change from Baseline in Distance Walked During the 6-Minute Walk Test(Baseline, Week 72)
- Change from Baseline in Waist Circumference(Baseline, Week 72)
- Percent Change from Baseline in Tumor Necrosis Factor (TNF)-Alpha(Baseline, Week 72)
- Change from Baseline in WOMAC Total Score(Baseline, Week 72)
- Change from Baseline in SF-36v2 Acute Form Domain Scores(Baseline, Week 72)
- Percentage of Participants Who Achieve Improved Categorical Shift in Patient Global Impression of Severity (PGIS) - Target Knee Function(Baseline, Week 72)
- Percentage of Participants Who Achieve Improved Categorical Shift in PGIS - Target Knee Pain(Baseline, Week 72)
- Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS) Score(Baseline, Week 72)
- Number of Participants with Allowed Concomitant Pain Medication(Baseline, Week 72)
- Percent Change from Baseline in Total Cholesterol(Baseline, Week 72)
- Change from Baseline in the WOMAC Physical Function Subscale Score(Baseline, Week 72)
- Percent Change from Baseline in Body Weight(Baseline, Week 72)
- Change from Baseline in 36-item, Short-Form Health Survey, version 2 (SF-36v2) Acute Form Physical Functioning Domain Score(Baseline, Week 72)
- Change from Baseline in Distance Walked During the 6-Minute Walk Test(Baseline, Week 72)
- Percent Change from Baseline in High-Sensitivity, C-reactive Protein (hsCRP)(Baseline, Week 72)
- Change from Baseline in Waist Circumference(Baseline, Week 72)
- Percent Change from Baseline in Tumor Necrosis Factor (TNF)-Alpha(Baseline, Week 72)
- Change from Baseline in WOMAC Stiffness Subscale(Baseline, Week 72)
- Change from Baseline in WOMAC Total Score(Baseline, Week 72)
- Change from Baseline in SF-36v2 Acute Form Domain Scores(Baseline, Week 72)
- Percentage of Participants Who Achieve Improved Categorical Shift in Patient Global Impression of Severity (PGIS) - Target Knee Function(Baseline, Week 72)
- Percentage of Participants Who Achieve Improved Categorical Shift in PGIS - Target Knee Pain(Baseline, Week 72)
- Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS) Score(Baseline, Week 72)
- Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS) Score(Baseline, Week 72)
- Number of Participants with Allowed Concomitant Pain Medication(Baseline, Week 72)
- Percent Change from Baseline in Total Cholesterol(Baseline, Week 72)
- Pharmacokinetics (PK): Steady-State Area Under the Curve (AUC) of Orforglipron(Predose through Week 48)
研究者
研究点 (173)
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