NCT07321886招募中3 期
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Obesity or Overweight, Without Type 2 Diabetes
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
- 1,980
- 试验地点
- 324
- 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 evaluate the efficacy and safety of eloralintide in adults with obesity or overweight who do not have type 2 diabetes. The study has two phases: a main phase and an extension phase.
Participation in the main phase of the study will last about 75 weeks. Participants with prediabetes will continue in the extension phase for another 2 years.
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 Body Mass Index (BMI) at screening of the following:
- •30 kilogram per square meter (kg/m2) OR
- •27 kg/m2 with at least one of the following weight-related health conditions at screening:
- •high blood pressure
- •dyslipidemia
- •obstructive sleep apnea, or
- •heart disease
- •Have a stable body weight (<5% body weight change) for 90 days prior to screening.
- •Have a history of at least one self-reported unsuccessful dietary effort to reduce body weight
排除标准
- •Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed >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 or type 2 diabetes
- •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
Placebo Comparator
Participants will receive placebo SC
干预措施: Placebo (Drug)
Eloralintide Dose 2
Experimental
Participants will receive eloralintide SC
干预措施: Eloralintide (Drug)
Eloralintide Dose 3
Experimental
Participants will receive eloralintide SC
干预措施: Eloralintide (Drug)
Eloralintide Dose 4
Experimental
Participants will receive eloralintide SC
干预措施: Eloralintide (Drug)
Eloralintide Dose 1
Experimental
Participants will receive eloralintide subcutaneously (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
次要结局
- Percent Change from Baseline in Total Body Fat Mass(Baseline, Week 64)
- Change from Baseline in Waist Circumference(Baseline, Week 64)
- Percent Change from Baseline in Triglycerides(Baseline, Week 64)
- Change from Baseline in Systolic Blood Pressure (SBP)(Baseline, Week 64)
- Time to Onset of Type 2 Diabetes (T2D)(Baseline to Week 168 and Week 191)
- Change from Baseline in Body Mass Index (BMI)(Baseline, Week 64)
- Change from Baseline in Hemoglobin A1c (HbA1c)(Baseline, Week 64)
- Percent Change from Baseline in Fasting Insulin(Baseline, Week 64)
- Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)(Baseline, Week 64)
- Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)(Baseline, Week 64)
- Change from Baseline in Short Form-36 Version 2 (SF-36 v2) Score(Baseline, Week 64)
- Change from Baseline in Control of Eating Questionnaire (CoEQ) Score(Baseline, Week 64)
- PK: Area Under the Concentration Versus Time Curve for One Dosing Interval at Steady State (AUC(0-ᴛ)ss)(Baseline through Week 64)
- Percent Change from Baseline in Total Body Fat Mass(Baseline, Week 64)
- Change from Baseline in Waist Circumference(Baseline, Week 64)
- Percent Change from Baseline in Triglycerides(Baseline, Week 64)
- Change from Baseline in Systolic Blood Pressure (SBP)(Baseline, Week 64)
- Time to Onset of Type 2 Diabetes (T2D)(Baseline to Week 168 and Week 191)
- Change from Baseline in Body Mass Index (BMI)(Baseline, Week 64)
- Change from Baseline in Hemoglobin A1c (HbA1c)(Baseline, Week 64)
- Change from Baseline in Short Form-36 Version 2 (SF-36 v2) Score(Baseline, Week 64)
- Percent Change from Baseline in Fasting Insulin(Baseline, Week 64)
- Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)(Baseline, Week 64)
- Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)(Baseline, Week 64)
- Change from Baseline in EQ-5D-5L(Baseline, Week 64)
- Change from Baseline in Control of Eating Questionnaire (CoEQ) Score(Baseline, Week 64)
- Achievement of Improved Categorical Shift in Patient Global Improvement of Status (PGIS) Physical Function Weight(Baseline, Week 64)
- Change in Medication Use(Baseline through Week 64)
- Percent Change from Baseline in Body Weight in Participants with Prediabetes at Randomization(Baseline, Week 168)
- 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-ᴛ)ss)(Baseline through Week 64)
研究者
研究点 (324)
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