A Randomized, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of ALT-801 in Healthy Overweight and Obese Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
This study was a FIH, Phase 1, randomized, double-blind, placebo-controlled, 2-part single-ascending dose (SAD) and multiple-ascending dose (MAD) study of ALT-801 (pemvidutide) in healthy overweight and obese subjects.
The purpose of the study was to assess the safety and tolerability in healthy overweight and obese volunteers administered single or multiple repeated doses of ALT-801 (pemvidutide).
详细描述
This study had 2 parts. Part 1 involved single dose cohorts of ALT-801 (pemvidutide) or placebo taken as a subcutaneous (SC) injection and was approximately 36 days in duration. Part 2 involved multiple dose cohorts of ALT-801 (pemvidutide) or placebo taken once a week for 12 weeks as a SC injection and was approximately 116 days in duration. Each participant enrolled in only one part.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female healthy volunteers, age 18 to 60 years, inclusive
- •Overweight to obese (BMI 25.0 - 40.0 kg/m2)
- •MRI-PDFF≥ 10% (Part 2 only)
- •Non-smokers or ex-smokers (must have ceased smoking > 1 months prior to screening visit)
- •Subjects must otherwise be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at screening, and/or before administration of the initial dose of study medication
- •Ability and willingness to attend the necessary visits to the study center
- •Written informed consent signed prior to entry into the study
排除标准
- •Women who are pregnant or breastfeeding
- •History of pancreatitis
- •History of or acute significant GI disorder
- •History of diabetes or use of medications for the treatment of diabetes, or hyperglycemia or HbA1c ≥ 6.5%
- •History of clinically significant endocrine (eg, hypothyroidism), neurological, GI, cardiovascular (except controlled hypertension and hypercholesterolemia), hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
- •History of neoplastic disease, or personal or family history of multiple endocrine neoplasia or medullary cancer of the thyroid, with the following exceptions:
- •Adequately treated non-melanomatous skin carcinoma
- •Female with a history of benign cervical neoplasia if the subject has been compliant with surveillance and treatment as recommended by her physician
- •Blood pressure > 150/90 mmHg or heart rate > 100 beats per minute at screening and at Day -1
- •Clinically significant laboratory abnormalities including:
- •Impaired renal function (estimated glomerular filtration rate [eGFR] <60 mL/min/1.73m2) as estimated using the MDRD equation at screening:
- •GFR (mL/min/1.73 m²) = 175 × (SCr/88.4)-1.154 × (Age)-0.203 × (0.742 if female) × (1.212 if African American) (SI units), where SCr is standardized serum creatinine in SI units (µmol/L) and age is in years
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) laboratory values > 2 × upper normal limits
- •Calcitonin > 50 ng/L - Excessive alcohol consumption defined as >21 alcohol units per week for males and as >14 alcohol units per week for females (where 1 unit = half pint of beer, 25 mL of 40% spirit, or 125 mL of wine)
研究组 & 干预措施
ALT-801 (Part 1)
Single ascending dose (SAD) cohorts of ALT-801
干预措施: ALT-801 (Drug)
Placebo (Part 1)
Single dose of placebo
干预措施: Placebo (Other)
ALT-801 (Part 2)
Multiple ascending dose (MAD) cohorts of ALT-801 administered once weekly for 12 weeks
干预措施: ALT-801 (Drug)
Placebo (Part 2)
Placebo administered once weekly for 12 weeks
干预措施: Placebo (Other)
结局指标
主要结局
The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
时间窗: Part 1 SAD Cohorts: up to Day 26; Part 2 MAD Cohorts: up to Day 42
Change in body weight
时间窗: Baseline to Week 6
Pharmacodynamic (PD): Change from baseline in magnetic resonance derived proton density fat fraction (MRI-PDFF)
时间窗: Baseline to Week 6
Pharmacokinetic (PK): Maximum observed concentration (Cmax) of ALT-801
时间窗: Baseline, Day 26
Pharmacokinetic (PK): Area Under the Concentration (AUC) vs Time Curve of ALT-801
时间窗: Baseline to Day 26
次要结局
未报告次要终点