NCT06417697尚未招募1 期
A Phase 1b, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Effects of XEN-101 on Safety, Tolerability, and Pharmacodynamics in Subjects With Obesity
Xeno Biosciences1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年6月最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Incidence of treatment emergent adverse events (safety and tolerability)
研究概览
简要总结
This Phase 1b study will evaluate the effects of XEN-101 in subjects with obesity
详细描述
This study will assess the safety, tolerability and weight loss associated with XEN-101 in obese men and women.
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
- 否
入选标准
- •Male or female, age 18 to 60 years, inclusive, at Screening
- •Body mass index of 30 to 45 kg/m2
- •Stable body weight for at least 3 months (i.e., fluctuation of ≤5%)
- •If a female of childbearing potential, must agree to use double barrier contraception (e.g., condom and 1 additional form of adequate contraception) from the date of signing of the ICF, throughout the study, and for 4 weeks after the final dose of study drug. In addition, she must be advised not to donate ova during this period. If a non-sterilized male is sexually active with a female partner of childbearing potential, he must use double barrier contraception from the date of signing of the ICF, throughout the study, and for 8 weeks after the final dose of study drug. In addition, he must be advised not to donate sperm during this period
- •If a female of childbearing potential, must have a negative pregnancy test at Screening and on Day 1 (baseline)
- •Able to provide informed consent
- •Willing and able to comply with this protocol and procedures, including feces collection, and be available for the entire duration of the study
排除标准
- •Currently enrolled in another investigational device or drug study, or less than 30 days or 5 times the half-life of the drug candidate (whichever is longer) has passed between Screening for this study and the end of the Treatment Period of the previous investigational device or drug study
- •Diagnosed with type 1 diabetes or type 2 diabetes (T2D) (resolution of T2D >3 years before Screening is allowed)
- •Laboratory evidence during Screening of T2D, including glycated hemoglobin (HbA1c) ≥6.5% or fasting glucose ≥126 mg/dL (≥7.0 mmol/L)
- •Evidence of clinically significant cardiac, neurologic, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, or gastrointestinal disease that, in the Investigator's opinion, would compromise the safety of the subject, interfere with the interpretation of the study results, or otherwise preclude subject participation
- •Female who is pregnant, nursing, or intends to become pregnant during the study.
- •Positive result for hepatitis B virus surface antigen, hepatitis C virus ribonucleic acid, and human immunodeficiency virus (HIV) antibody at Screening
- •Use of anti-obesity medications (e.g., glucagon-like peptide-1 analogues, stimulants, bupropion/naltrexone) within 6 months before Screening
研究组 & 干预措施
XEN-101
Experimental
干预措施: XEN-101 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of treatment emergent adverse events (safety and tolerability)
时间窗: Day 1 through Day 43
Assessing the type and frequency of adverse events
Effect on body weight
时间窗: Day 1 through Day 43
change and percent change from baseline
次要结局
未报告次要终点
研究者
研究点 (1)
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