A Randomized, Double-Blind, Placebo-Controlled Phase 1/2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effect on Body Weight of RN3161 as Monotherapy and in Combination With Tirzepatide in Adults With Overweight and Obesity
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- ECG PR interval
研究概览
简要总结
Study to assess the safety, pharmacokinetics (the amount of study drug or any of its breakdown products in your body) and pharmacodynamics (how the study drug affects your body) of RN3161 alone (healthy volunteers) and RN3161 with tirzepatide (overweight and obese subjects)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Obesity: BMI ≥ 30 kg/m² for participants with no Asian ancestry and ≥ 27.5 kg/m² for participants with Asian ancestry that has been stable (± 5%) for the previous 3 months (based on participant self-report or available medical records), with or without a weight-related comorbidity (excluding diabetes)
- •Overweight: BMI 27 to <30 kg/m² for participants with no Asian ancestry and 23.0 to <27.5 kg/m² for participants with Asian ancestry that has been stable (± 5%) for the previous 3 months (based on participant self-report or available medical records), with at least 1 weight-related comorbidity (excluding diabetes)
- •Weight-related comorbidities include a diagnosis of the following:
- •Hypertension: seated BP ≤ 140/90 mm Hg; receiving ≤ 2 stable (≥ 4 weeks) agents limited to ACE inhibitors, angiotensin receptor blockers, calcium channel blockers, or thiazide ≤ 25 mg, or untreated
- •Dyslipidemia: stable use of lipid-lowering agents for dyslipidemia (LDL-C < 150 mg/dL, triglycerides < 300 mg/dL)
- •Osteoarthritis
排除标准
- •self-reported or documented weight gain or loss >5% within 3 months prior to screening
- •use of GLP1R agonists within 6 months of screening
- •intolerance to GLP-1 medications in the past
- •use of non-GLP1R medications for weight loss within 3 months of screening
- •HbA1c >6.5%
- •diagnosis of significant liver disease
- •history of malignancy or anaphylaxis
- •use of any siRNA agent in the prior 12 months
研究组 & 干预措施
RN3161
Investigational Product
干预措施: RN3161 (Drug)
Placebo Control
placebo control
干预措施: Placebo Control (Drug)
RN3161 and tirzepatide
In Part 3, RN3161 co-administered with tirezepatide
干预措施: RN3161 (Drug)
RN3161 and tirzepatide
In Part 3, RN3161 co-administered with tirezepatide
干预措施: Tirzepatide (Drug)
Placebo and tirzepatide
In Part 3; Placebo co-administered with tirzepatide
干预措施: Placebo Control (Drug)
Placebo and tirzepatide
In Part 3; Placebo co-administered with tirzepatide
干预措施: Tirzepatide (Drug)
结局指标
主要结局
ECG PR interval
时间窗: 180 days
Number of participants with change in PR interval measured as milliseconds
ECG QRS Complex
时间窗: 180 days
Number of participants with changes in QRS complex measured in milliseconds
ECG QT interval
时间窗: 180 days
Number of participants with change in QT interval measured by Frederica method in milliseconds
Blood Pressure
时间窗: 180 Days
Number of participants with blood pressure changes measured in mmHg
Blood Hematology Laboratory
时间窗: 180 days
Number of participants with changes in blood hemoglobin, hematocrit, platelets, neutrophils and leukocytes measured in standard units
Physical Examination
时间窗: 180 days
Number of participants with changes seen by physical examination of skin, lymph nodes, eyes, ears, throat, chest, abdomen, musculoskeletal system and nervous system
Adverse Events
时间窗: 180 days
Incidence of adverse events reported
Blood Chemistry Laboratory
时间窗: 180 days
Number of participants with changes in blood levels of sodium, potassium, chloride, calcium magnesium, creatinine, bilirubin, phosphate, AST, ALT, alkaline phosphatase, glucose, albumin, urea in standard units
Heart Rate
时间窗: 180 days
Number of participants with change in heart rate measured in beats per minute
Blood Coagulation Laboratory
时间窗: 180 days
Number of participants with changes in plasma prothrombin time, activated partial thromboplastin time, and international normalized ratio measured in standard units
次要结局
- Plasma and Urine Pharmacokinetics(180 Days)
- Presence of ADA(180 days)