A Phase 1, Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of HM15136(Efpegerglucagon) in Obese or Overweight Subjects With Comorbidities
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- To Evaluate the Incidence of AEs
研究概览
简要总结
The planned period of each cohort is 22 weeks including subject screening, treatments for 12 weeks, and follow up period.
详细描述
The current Phase I study was a two-part study. Part 1 was designed to assess the safety, PK, and pharmacodynamics (PD) after repeated doses of HM15136 in obese or overweight subjects with comorbidities (i.e., dyslipidemia and/or hypertension). Part 2 was designed to assess the safety, PK, and PD after repeated doses of HM15136 in obese or overweight subjects with T2DM and comorbidities (i.e., dyslipidemia and/or
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female subjects
- •Age ≥ 18 to ≤ 65 years at Screening visit
- •Body Mass Index ( BMI ≥ 30 kg/m 2 or 27 kg/m 2 with presence of comorbidities (Subjects in Part 1 and Subjects with Pre diabete s mellitus (DM) in Part 2: dyslipidemia and or hypertension except for Type 2 (T2) DM, T2DM subjects in Part 2: dyslipidemia and/or hypertension with T2DM) with/without medication treatment and have had stable weight for 3 months (weight changes less than 5%)
排除标准
- •Previous surgical treatment for obesity (bariatric surgery, gastric banding, etc.) or any other gastrointestinal surgery that may induce malabsorption, history of bowel resection > 20 cm, any malabsorption disorder, severe gastroparesis, any GI procedure for weight loss (including LAPBAND®), as well as clinically significant gastrointestinal disorders (e.g. peptic ulcers, severe GERD ) at Screening.
- •Use of antacids, anticoagulants, or drugs that directly modify gastrointestinal (GI) motility, including antacid s anticholinergics, anticonvulsants, serotonin type 3 (5HT3) antagonists, dopamine antagonists, opiates; anticoagulation within 2 weeks of screening (But, it is not limited to the above listed drugs.)
- •Uncontrolled hypertension, defined as systolic blood pressure > 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg at screening independent of subjects being on antihypertensive medication or no t). But, if the results are out of the reference range at the screening visit, they can be tested again on another day. Subjects with uncontrolled hypertension may be rescreened after 3 months, following initiation or adjustment of antihyp ertensive therapy.)
研究组 & 干预措施
HM15136
HM15136 0.02mg/kg, 0.04mg/kg, 0.06mg/kg
干预措施: HM15136 (Drug)
Placebo
Matching placebo: 0.02mg/kg, 0.04mg/kg, 0.06mg/kg
干预措施: Placebo (Drug)
结局指标
主要结局
To Evaluate the Incidence of AEs
时间窗: after multiple subcutaneous (SC) doses for 12 weeks
To evaluate the incidence of AEs: Skin and subcutaneous tissue disorders
To Evaluate Serum Amylase Levels at 12 Weeks
时间窗: after multiple subcutaneous (SC) doses for 12 weeks
To evaluate the incidence of clinical lab abnormalities of serum amylase
Change From Baseline in Tympanic Temperature
时间窗: after multiple subcutaneous (SC) doses for 12 weeks
tympanic temperature change
Change From Baseline in 12-lead ECG Parameters
时间窗: after multiple subcutaneous (SC) doses for 12 weeks
QT interval corrected for HR using Fridericia's correction \[QTcF\]
Injection Site Reactions
时间窗: after multiple subcutaneous (SC) doses for 12 weeks
Injection site reactions occurance
次要结局
- Serum Lipid Profiles(Change from baseline to end of treatment (12 weeks))