A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABBV-295 in Healthy Japanese Subjects With Overweight or Obesity
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Number of Participants with Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to assess the adverse events, tolerability, and Pharmacokinetics (PK) of subcutaneous injections of ABBV-295 in healthy adult Japanese participants with overweight or obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Japanese participant must be first-or second-generation Japanese of full Japanese parentage.
- •First-generation participants will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent.
- •Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent.
- •BMI is ≥ 23.0 to ≤ 35.0 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
排除标准
- •Participant has a self-reported change in body weight ≥ 5% within 3 months prior to Screening.
- •HbA1c ≥ 6.5% and/or serum glucose ≥ 126 mg/dL at Screening.
- •Participant has taken a medication for the purpose of treating obesity (e.g. Glucagon-like peptide-1, (GLP-1) agonists, Glucagon-like peptide-1/glucose-dependent insulinotropic polypeptide (GLP-1/GIP) agonists, bupropion-naltrexone, orlistat, metformin, phentermine-topiramate, amphetamine based stimulants, methylphenidate) or has been enrolled in an obesity trial within 180 days prior to study treatment administration.
研究组 & 干预措施
ABBV-295 Part 1
Participants will receive subcutaneous doses of ABBV-295 for 12 weeks.
干预措施: ABBV-295 (Drug)
Placebo for ABBV-295 Part 1
Participants will receive subcutaneous doses of placebo for 12 weeks.
干预措施: Placebo for ABBV-295 (Drug)
ABBV-295 Part 2
Participants will receive subcutaneous doses of ABBV-295 for 12 weeks.
干预措施: ABBV-295 (Drug)
Placebo for ABBV-295 Part 2
Participants will receive subcutaneous doses of placebo for 12 weeks.
干预措施: Placebo for ABBV-295 (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AEs)
时间窗: Up to approximately 138 days
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
次要结局
未报告次要终点