NCT05925920已完成1 期
A First in Human, Single Center, Single Dose, Randomized, Placebo-controlled, Dose, Escalating Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered ENT-03S for the Treatment of Obesity and Diabetes
Metabolics Pharma2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2023年6月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Safety and Tolerability of ENT-03
研究概览
简要总结
Single center, single-dose, randomized, placebo-controlled, dose-escalating study to evaluate, safety, tolerability, pharmacokinetics, and pharmacodynamics of escalating doses of ENT-03S in obese but otherwise healthy subjects and in subjects with obesity and Type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged 18-70 years, both genders.
- •Healthy as determined by a physician, based on history, medical examination, vital signs, and laboratory tests.
- •Males that agree to use condoms for the duration of participation in the study.
- •Females of non-child-bearing potential (i.e., tubal ligation, hysterectomy, or postmenopausal).
- •Female patients of child-bearing potential with negative serum pregnancy tests and who agree to use double-barrier contraception during the study.
- •Subjects must be able to read, speak, and understand English and/or Spanish and provide written informed consent, and be willing and able to comply with study procedures.
- •Subjects must have a BMI 30-35 kg/m2 inclusive assessed immediately prior to screening.
- •Fasting insulin level ≥11 mIU/L.
- •HbA1c < 8.5% (diabetic subjects only).
- •Subjects with Type 2 diabetes on no anti-diabetic medication or on stable doses of metformin for 4 weeks or more (diabetic cohorts only).
- •No history of active or chronic disease other than that allowed by study: hypertension, hyperlipidemia, hyperglycemia, GERD, heartburn, or Type 2 diabetes (cohorts 6 and 7 only).
排除标准
- •History of excessive alcohol use (defined as >21 drinks per week for males and >14 drinks per week for females), recreational drug use within the past three months, or failure on urinary drug screen.
- •Pregnant or breastfeeding within six months of screening assessment.
- •Substantial changes in eating habits or exercise routine within the preceding three months.
- •Evidence of eating disorders.
- •>5% weight change in the past three months.
- •Bariatric surgery within the past five years.
- •Significant renal impairment (eGFR <60 mg/mL/1.73m2).
- •Patients on anti-diabetic medications other than metformin.
- •Patients with gastroparesis.
- •Liver function tests (i.e., ALT, AST, alkaline phosphatase) greater than twice the upper limit of normal upon repeated measurements.
- •Diseases interfering with metabolism and/or ingestive behavior (e.g., myxedema, Cushing's disease, schizophrenia, major psychoses).
- •History of major depressive disorder within the previous two years, a lifetime history of suicide attempt, suicidal behavior within the previous month, or history of other severe psychiatric disorders.
- •Score of >15 on the Columbia Suicide Severity Rating Scale (C-SSRS).
- •Use of medications affecting body weight within the past three months:
- •Drugs approved for the treatment of obesity
- •Cyproheptadine or medroxyprogesterone
- •Atypical anti-psychotic drugs
- •Tricyclic antidepressants
- •Lithium, MAO's, glucocorticoids
- •SSRI's or SNRI's
- •Antiepileptic drugs
- •Any clinically significant abnormality following the Investigator's review of the physical examination and clinical laboratory tests.
- •A baseline prolongation of QT/QTc interval after repeated measurements of >450 ms; a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS).
- •Participation in an investigational drug trial within the month prior to dosing in the present study.
研究组 & 干预措施
Placebo
Placebo Comparator
Receive a single dose of placebo sub-cutaneously
干预措施: Placebo (Drug)
Active
Active Comparator
Receive a single dose of ENT-03 sub-cutaneously
干预措施: ENT-03 (Drug)
结局指标
主要结局
Safety and Tolerability of ENT-03
时间窗: 7 days
Vital signs: body weight in kilograms
Safety and tolerability of ENT-03
时间窗: 7 days
Adverse Events
次要结局
- pharmacokinetic endpoints: maximum plasma concentration(pre-dose, 24 hours, 48 house, 72 hours)
- pharmacokinetic endpoints: time of maximum plasma concentration(pre-dose, 24 hours, 48 house, 72 hours)
- pharmacokinetic endpoints: ENT-03 half-life(pre-dose, 24 hours, 48 house, 72 hours)
- pharmacokinetic endpoints: plasma concentration(pre-dose, 24 hours, 48 house, 72 hours)
- pharmacokinetic endpoint: ENT-03 clearance(pre-dose, 24 hours, 48 house, 72 hours)
- pharmacokinetic endpoint: elimination phase(pre-dose, 24 hours, 48 house, 72 hours)
- pharmacodynamic endpoint: glucose(7 days)
- pharmacodynamic endpoint: insulin(7 days)
- pharmacodynamic endpoint: fasting lipids(7 days)
- pharmacodynamic endpoint: fasting leptin(7 days)
- pharmacodynamic endpoint: body weight(7 days)
- effect on glucose(Days -7, 2, 3, 4, and 7)
- effect on insulin and insulin sensitivity(Days -7, 2, 3, 4, and 7)
研究者
研究点 (2)
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