A Phase 1/2a, Randomized, Double-blind, Placebo-controlled Study of Ascending Doses of WVE-007 to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Adults Living With Overweight or Obesity
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 296
- 试验地点
- 11
- 主要终点
- The proportion of participants with adverse events
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ascending doses of WVE-007 when administered subcutaneously (SC) . Part A is a single ascending dose study in adults living with overweight and obesity. The Part B of the study is a repeat dose administration in two adult populations: Pre Type 2 diabetes (Pre T2D) and Type 2 Diabetes (T2D) in adults who are affected by obesity.
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
- Triple (Participant, Care Provider, 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 and female participants aged 18 to 60 years
- •BMI 28 to 35 kg/m2 which has been stable (±5%) for the previous 3 to 6 months (based on participant self-report or medical records). For participants considered for enrollment in a cohort expansion, BMI 28 to 40 kg/ m2 will be allowed.
- •Healthy, in the opinion of the Investigator, as determined by prestudy medical history, physical examination, and clinical laboratory assessments
- •Inclusion Criteria : Part B
- •Male and female participants aged 18 to 60 years
- •BMI 35 to 50 kg/m2 (inclusive)
- •Thyroid stimulating hormone is within normal range at Screening. May be on supplemental thyroid hormone as managed by their prescribing physician and stable within the last 60 days
- •Have Pre T2D or T2D
排除标准
- •History or presence of CV disease, including heart failure (New York Heart Association [NYHA] Class III or IV), myocardial infarction, angina, or clinically significant abnormal laboratory assessments
- •History or presence of thyroid disorders
- •Medical history or diagnosis of causes of liver disease
- •Use of any siRNA agent in the prior 12 months
- •Received an investigational agent within 90 days or 5 half-lives, whichever is longer, before the first dose of study drug or are in follow-up of another clinical study
- •Exclusion Criteria: Part B
- •History of significant CV disease in the opinion of the Investigator.
- •Use of prescription medications (ie, anti-obesity or psychiatric medications) within 14 days or 7 half-lives (whichever is longer) before the first dose of study drug, except for allowed antihypertensive medications and statins.
- •Taking >2 antihypertensive medications, or antihypertensive medication dose was changed in the 60 days prior to Screening.
- •Taking >1 cholesterol-lowering medication, or cholesterol-lowering medication dose was changed in the 60 days prior to Screening.
- •Cohorts 1 and 2 (preT2D) only: use of any GLP-1 receptor agonists or dual incretin agonists within the 4 months prior to Screening.
- •Cohorts 4 and 5 (T2D) only: use of insulin or any medication that directly stimulates pancreatic insulin within the 60 days prior to Screening, including sulfonylureas, meglitinides, GLP-1 receptor agonists, dual incretin agonists, and DPP-4 inhibitors.
- •Use of any siRNA agent in the prior 12 months.
- •Received an investigational agent within 90 days or 5 half-lives, whichever is longer, before the first dose of study drug or are in follow-up of another clinical study.
研究组 & 干预措施
Cohort 4
Part A: Experimental WVE-007 (Dose 4) or Placebo Part B T2D: Experimental WVE-007 (Dose 4) or Placebo
干预措施: WVE-007 (Drug)
Cohort 3
Part A: Experimental WVE-007 (Dose 3) or Placebo
干预措施: WVE-007 (Drug)
Cohort 2
Part A: Experimental WVE-007 (Dose 2) or Placebo Part B Pre-T2D: Experimental WVE-007 (Dose 2) or Placebo
干预措施: WVE-007 (Drug)
Cohort 5
Part A: Experimental WVE-007 (Dose 5) or Placebo Part B T2D: Experimental WVE-007 (Dose 5) or Placebo
干预措施: WVE-007 (Drug)
Cohort 1
Part A: Experimental WVE-007 (Dose 1) or Placebo Part B Pre-T2D: Experimental WVE-007 (Dose 1) or Placebo
干预措施: WVE-007 (Drug)
结局指标
主要结局
The proportion of participants with adverse events
时间窗: Day 1 through end of study
次要结局
- Maximum concentration of WVE-007 in plasma (Cmax)(Day 1 through 169)
- Area under the plasma concentration time curve for WVE-007 from time 0 to last measurable concentration (AUClast)(Day 1 through 169)
- Change over time from baseline levels of serum activin E(Day 1 through 169)
研究者
Clinical Operations
Scientific
Wave Life Sciences Ireland Limited