NCT07392190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 Persistent Obesity or Overweight Treated With a Weekly Incretin, With and 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
- 900
- 试验地点
- 185
- 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 efficacy and safety of eloralintide compared with placebo in participants with persistent obesity or overweight, with or without type 2 diabetes, and on stable incretin background therapy.
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
- •Are on stable incretin therapy at screening
- •With persistent obesity or overweight defined as:
- •≥30 kg/m2 OR
- •≥27 kg/m2 with at least one existing obesity related complication at screening:
- •hypertension
- •dyslipidemia
- •obstructive sleep apnea
- •cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure), or
- •type 2 diabetes
- •Have a stable body weight (<5% body weight change) at screening
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
- •Have taken any of the following antihyperglycemic medications within 90 days before screening:
- •dipeptidyl peptidase-4 (DPP-4) inhibitors
- •amylin analogs
- •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
研究组 & 干预措施
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)
Placebo
Placebo Comparator
Participants will receive placebo SC
干预措施: Placebo (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 in Baseline in Triglycerides(Baseline, Week 64)
- Change from Baseline in Waist Circumference(Baseline, Week 64)
- Change from Baseline in Systolic Blood Pressure(Baseline, Week 64)
- Change from Baseline in Body Mass Index (BMI)(Baseline, Week 64)
- Change from Baseline in Fasting Glucose in Participants with Type 2 Diabetes at Baseline(Baseline, Week 64)
- Change from Baseline in Short Form-36 (SF-36 v2) Score(Baseline, Week 64)
- Change from Baseline in EQ-5D-5L Score(Baseline, Week 64)
- Change in Medication Use(Baseline through Week 64)
- Change from Baseline in Control of Eating Questionnaire (CoEQ) Score(Baseline, Week 64)
- Achievement of Improved Categorical Shift in Patient Global Impression of Severity (PGIS) Physical Function Weight(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)
- 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 (185)
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