NCT07357415进行中（未招募）3 期
A Phase 3b Study to Investigate the Efficacy and Safety of Different Retatrutide Dose Escalation Schemes in Participants Without Type 2 Diabetes Who Have Obesity or Overweight: A Randomized, Controlled, Double-Blind Trial
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
- 600
- 试验地点
- 35
- 主要终点
- Percent Change from Baseline in Body Weight
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of different retatrutide dose escalation schemes in participants without type 2 diabetes who have obesity or overweight. Participation in the study will last about 113 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) at screening
- •≥ 30 kilogram per square meter (kg/m2) OR
- •≥ 27 kg/m2 with presence of at least one of the following weight-related conditions at screening: high blood pressure, abnormal levels of lipid, obstructive sleep apnea, heart disease
- •Have at least one unsuccessful attempt to lose weight by dieting
排除标准
- •Have a self-reported change in body weight >5 kilograms (kg) (11 pounds) within 90 days before screening
- •Have a prior or planned surgical treatment for obesity
- •Have type 1 diabetes or type 2 diabetes
- •Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- •Have had within the past 90 days before screening:
- •heart attack
- •hospitalization for unstable angina or heart failure
- •Have New York Heart Association Functional Classification Class IV congestive heart failure
- •Have a history of chronic or acute pancreatitis
- •Have taken weight loss drugs, including over-the counter medications within 90 days prior to screening
研究组 & 干预措施
Retatrutide Dose Escalation 2
Experimental
Participants will receive retatrutide SC
干预措施: Retatrutide (Drug)
Retatrutide Dose Escalation 3
Experimental
Participants will receive retatrutide SC
干预措施: Retatrutide (Drug)
Retatrutide Dose Escalation 1
Experimental
Participants will receive retatrutide subcutaneously (SC)
干预措施: Retatrutide (Drug)
结局指标
主要结局
Percent Change from Baseline in Body Weight
时间窗: Baseline, Week 104
次要结局
- Change from Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials (IWQOL-Lite-CT) Total Score(Baseline, Week 104)
- Overall Treatment Satisfaction with Medication for Obesity (TS-MO) Scores(Week 104)
- Pharmacokinetics (PK): Steady state Average Trough PK Concentration(Baseline through Week 104)
- Change from Baseline in Systolic Blood Pressure(Baseline, Week 104)
- Percent Change from Baseline in High Sensitivity C-Reactive Protein(Baseline, Week 104)
- Change from Baseline in Waist Circumference(Baseline, Week 104)
- Percent Change from Baseline in Triglycerides(Baseline, Week 104)
研究者
研究点 (35)
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