NCT07589686尚未招募2 期
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy and Safety of Petrelintide Co-Administered With RO7795068 in Adults With Obesity or Overweight
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 486
研究概览
简要总结
The main purpose of this study is to evaluate the safety and efficacy of the co-administration of petrelintide and enicepatide compared with placebo, petrelintide monotherapy, and enicepatide monotherapy in participants with obesity or overweight with at least one weight-related comorbidity.
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
- •Male or female participants with Body Mass Index (BMI) ≥ 30 kg/m² OR BMI ≥ 27 kg/m² to < 30 kg/m² with at least one weight-related comorbidity
- •History of at least one self-reported unsuccessful dietary effort to lose body weight
排除标准
- •HbA1c ≥ 48 mmol/mol (6.5%) at screening
- •History of Type 1 or Type 2 Diabetes
- •Self-reported change in body weight > 5 kg within 90 days prior to screening
- •Previous or planned obesity treatment with surgery (excluding liposuction, cryolipolysis, or abdominoplasty if performed > 1 year prior to or during screening)
- •Previous or planned endoscopic and/or device-based obesity treatment or removal or device within the last 6 months prior to screening (e.g., mucosal ablation, gastric artery embolization, intragastric balloon and duodenal-jejunal endoluminal liner)
- •Treatment with any GLP-1 receptor agonist, GLP-1/GIP receptor agonist (or any other GLP-1 based treatment) within 180 days prior to or during screening
- •Current or previous treatment with petrelintide or any other amylin analog
- •Obesity induced by Cushing syndrome or a diagnosis of monogenetic or syndromic forms of obesity
- •History of severe psychiatric disorders
- •History of any hematologic conditions that may interfere with HbA1c measurement
- •Known history or presence of pancreatitis
- •Known clinically significant gastric emptying abnormality or chronic treatment that affects GI motility
- •New York Heart Association Functional Classification IV heart failure
- •Pregnant or breastfeeding, or intending to become pregnant during the study or within the time frame in which contraception is required
研究组 & 干预措施
Arm 1: Petrelintide + Enicepatide Dosing Regimen 1
Experimental
干预措施: Enicepatide (Combination Product)
Arm 2: Petrelintide + Enicepatide Dosing Regimen 2
Experimental
干预措施: Enicepatide (Combination Product)
Arm 3: Petrelintide + Enicepatide Dosing Regimen 3
Experimental
干预措施: Enicepatide (Combination Product)
Arm 5: Petrelintide + Enicepatide-matching Placebo
Experimental
干预措施: Petrelintide (Drug)
Arm 4: Petrelintide-matching Placebo + Enicepatide
Experimental
干预措施: Enicepatide (Combination Product)
Arm 4: Petrelintide-matching Placebo + Enicepatide
Experimental
干预措施: Petrelintide-matching Placebo (Drug)
Arm 2: Petrelintide + Enicepatide Dosing Regimen 2
Experimental
干预措施: Petrelintide (Drug)
Arm 1: Petrelintide + Enicepatide Dosing Regimen 1
Experimental
干预措施: Petrelintide (Drug)
Arm 3: Petrelintide + Enicepatide Dosing Regimen 3
Experimental
干预措施: Petrelintide (Drug)
Arm 6: Petrelintide-matching Placebo + Enicepatide-matching Placebo
Placebo Comparator
干预措施: Enicepatide-matching Placebo (Combination Product)
Arm 5: Petrelintide + Enicepatide-matching Placebo
Experimental
干预措施: Enicepatide-matching Placebo (Combination Product)
Arm 6: Petrelintide-matching Placebo + Enicepatide-matching Placebo
Placebo Comparator
干预措施: Petrelintide-matching Placebo (Drug)
研究者
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