A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of HM15211(Efocipegtrutide) in Obese Subjects With NAFLD
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
This study is a phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of HM15211 in obese subjects with NAFLD
详细描述
This study will be single-blind and conducted in up to 6 cohorts comprising a total of up to 72 obese subjects with NAFLD. Each cohort will enroll subjects to ensure that at least 12 subjects per cohort will complete the study. Subjects will be randomized to investigational product (IP) or placebo in a 3:1 ratio via an Interactive Web Response System (IWRS). Per cohort (n=12 subjects), 9 subjects will be randomized to IP and 3 subjects to placebo. Cohorts may partially overlap after at least 9 subjects have completed 2-4 weeks of treatment (2 weeks of treatment is reached at Visit week 3) and a dose escalation decision has been made. Study drug will be administered weekly over a period of 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Body mass index ≥ 30 kg/m2
- •Waist circumference ≤ 57 inches
- •Fasting Plasma Glucose < 7 mmol/L (126 mg/dL)
- •HbA1c < 6.5%
- •Controlled Attenuation Parameter ≥ 300 dB/m by FibroScan
- •Liver fat by MRI-PDFF ≥ 10%.
排除标准
- •A history of or active chronic liver disease due to alcohol, auto-immune, HIV, HBV or active HCV-infection or NASH disease
- •Any history of clinically significant chronic liver disease including esophageal varices, ascites, encephalopathy or any hospitalization for treatment of chronic liver disease; or Model for End Stage Liver Disease (MELD) ≥ 10
- •Previous surgical treatment for obesity
- •Uncontrolled hypertension
- •Any weight control treatment
- •History or current diagnosis of acute or chronic pancreatitis or factors for pancreatitis
- •History of major depression, anxiety, suicidal behavior or attempts, or other psychiatric disorder requiring medical treatment
- •History or current diagnosis of heart disease
- •Presence of clinically significant ECG findings
- •History of renal disease or abnormal kidney function tests
- •History of alcohol or illicit drug abuse
- •Daily heavy use of cigarettes or any tobacco product
研究组 & 干预措施
HM15211
干预措施: HM15211 (Drug)
Placebo
干预措施: Placebo of HM15211 (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: 12 weeks
Cardiovascular events, rash/inflammatory dermatitis and other skin disorders, GI events, and gallstone formation \[cholelithiasis\] were managed following a separate AE guidance document
Incidence of Clinical Renal Function Lab Abnormalities
时间窗: baseline and 12 weeks
Observed Values and Change from Baseline in Renal Function of Urea Nitrogen
Vital Signs
时间窗: baseline and 12 weeks
Change from baseline in vital signs (Systolic Blood)
12-lead ECG
时间窗: baseline and 12 weeks
Change from baseline in 12-lead ECG; the primary ECG endpoint was QTcF
次要结局
- Body Mass Index(baseline and 12 weeks)