NCT07035093进行中（未招募）3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly in Participants Who Have Obesity or Overweight and Chronic Low Back Pain
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 586
- 试验地点
- 91
- 主要终点
- Change from Baseline in Pain Intensity Per Numeric Rating Scale
研究概览
简要总结
The main purpose of this study is to evaluate the efficacy and safety of retatrutide in relieving chronic low back pain in participants who have obesity or overweight. Participation in the study will last about 80 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 history of axial-predominant low back pain
- •Have pain that is restricted to the low back or with a referral pattern limited to the proximal legs
- •Have a body mass index (BMI) ≥27 kilograms per square meter (kg/m2) at screening
- •Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight
排除标准
- •Have a non-axial origin low back pain
- •Have had botulinum or steroid injections to the spine within 1 year of screening
- •Have had trigger point injection to the spine within 6 months of screening
- •Have a self-reported change in body weight >5 kilograms (kg) (11 pounds) within 90 days prior to screening
- •Have been taking drugs to promote body weight reduction, including over-the-counter medications, within 90 days prior to screening
- •Have a prior or planned surgical treatment for obesity
- •Have Type 1 Diabetes, Type 2 Diabetes, or any other type of diabetes
研究组 & 干预措施
Retatrutide
Experimental
Participants will receive Retatrutide subcutaneously (SC)
干预措施: Retatrutide (Drug)
Placebo
Placebo Comparator
Participants will receive Placebo SC
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline in Pain Intensity Per Numeric Rating Scale
时间窗: Baseline, up to 72 weeks
Percent Change from Baseline in Body Weight
时间窗: Baseline, up to 72 weeks
次要结局
- Change in Waist Circumference(Baseline, up to 72 weeks)
- Change in Blood Pressure(Baseline, up to 72 weeks)
- Change in Glycemic Control(Baseline, up to 72 weeks)
- Number of Participants with Reduction in Body Weight(Baseline, up to 72 weeks)
- Change in Pain Interference as Measured by PROMIS(Baseline, up to 72 weeks)
- Change in Sleep as Measured by PROMIS(Baseline, up to 72 weeks)
- Number of Participants with Reduction in Pain Intensity Per Numeric Rating Scale(Baseline, up to 72 weeks)
- Change in Physical Function as Measured by Patient-Reported Outcomes Measurement Information Systems (PROMIS)(Baseline, up to 72 weeks)
- Percent Change in Total Cholesterol(Baseline, up to 72 weeks)
- Change in Patient Reported Health Outcomes as Measured by Medical Outcomes Study 36-item Short Form Health Survey version 2 (SF-36v2)(Baseline, up to 72 weeks)
- Change in Biomarkers of Inflammation as Measured by Blood Test(Baseline, up to 72 weeks)
- Percent Change in Urine Albumin-to-Creatinine Ratio (UACR)(Baseline, up to 72 weeks)
研究者
研究点 (91)
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