NCT05931367已完成3 期
A Phase 3 Study to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee: A Randomized, Double-Blind, Placebo-Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 445
- 试验地点
- 47
- 主要终点
- Percent Change from Baseline in Body Weight
研究概览
简要总结
The main purpose of this study is to evaluate the safety and efficacy of retatrutide once-weekly in participants who have obesity or are overweight and have osteoarthritis (OA) of the knee. The study will lasts about 77 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
- 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) ≥27 kilogram/kg/m² at screening.
- •Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
- •Have index knee pain for >12 weeks prior to screening, and presence of index knee pain for >15 days over the previous month.
- •Have knee X-ray with moderate radiographic changes (Kellgren-Lawrence Grade 2 or 3) per central reading at screening.
- •Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA.
排除标准
- •Have had steroid joint injections within 90 days of screening.
- •Have had other joint injections and procedures within 6 months of screening.
- •Have joint disease other than osteoarthritis.
- •Have a self-reported or documented change in body weight >5 kg (11 pounds) within 90 days prior to screening.
- •Have been taking weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
- •Have a prior or planned surgical treatment for obesity.
- •Have diabetes mellitus.
研究组 & 干预措施
Retatrutide Dose 2
Experimental
Participants will receive retatrutide SC.
干预措施: Retatrutide (Drug)
Retatrutide Dose 1
Experimental
Participants will receive retatrutide subcutaneously (SC).
干预措施: Retatrutide (Drug)
Placebo
Placebo Comparator
Participants will receive placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change from Baseline in Body Weight
时间窗: Baseline, Week 68
Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
时间窗: Baseline, Week 68
次要结局
- Percent Change from Baseline in Triglycerides(Baseline, Week 68)
- Change from Baseline in Body Mass Index (BMI)(Baseline, Week 68)
- Percent Change from Baseline in Total Cholesterol(Baseline, Week 68)
- Change from Baseline in Waist Circumference(Baseline, Week 68)
- Change from Baseline in the WOMAC Physical Function Subscale Score(Baseline, Week 68)
- Change from Baseline in Systolic Blood Pressure (SBP)(Baseline, Week 68)
- Change from Baseline in Diastolic Blood Pressure (DBP)(Baseline, Week 68)
- Percent Change from Baseline in Fasting Insulin(Baseline, Week 68)
- Change from Baseline in Short Form 36-Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score(Baseline, Week 68)
- Change from Baseline in Average Pain Intensity Numeric Rating Score (API-NRS) Score(Baseline, Week 68)
- Change from Baseline in Worst Pain Intensity Numeric Rating Score (WPI-NRS) Score(Baseline, Week 68)
研究者
研究点 (47)
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