NCT07594093招募中1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of REGN20934 in Adult Participants With Overweight or Obesity
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Occurrence of Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
This study will test a study drug called REGN20934 to see how safe and well tolerated this drug is, as well as how the drug is processed in the body for participants with overweight or obesity.
The study is looking at:
- What side effects REGN20934 might cause
- How much REGN20934 is in the blood at different times
- If the body makes antibodies to REGN20934
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Sponsor unblinded
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
- 是
入选标准
- •Has a Body Mass Index (BMI) 25 to 35 kg/m^2
- •Females must be of non-childbearing potential
排除标准
- •A self-reported change of body weight >5 kg within approximately 90 days of visit 2
- •History of type 1 or type 2 diabetes
- •History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease, as defined in the protocol
- •Note: Other protocol defined inclusion/exclusion criteria apply
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
REGN20934
Experimental
干预措施: REGN20934 (Drug)
结局指标
主要结局
Occurrence of Treatment Emergent Adverse Events (TEAEs)
时间窗: Up to 16 weeks
Severity of TEAEs
时间窗: Up to 16 weeks
次要结局
- REGN20934 concentration in serum(Up to 16 weeks)
- Occurrence of Anti-Drug Antibodies (ADAs) to REGN20934(Up to 16 weeks)
- Magnitude of ADAs to REGN20934(Up to 16 weeks)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
1 期
A First in Human Study to Assess Safety, Tolerability and Pharmacokinetics of a Single Dose of REGN22044 in Healthy AdultsHealthy VolunteerNCT07526116Regeneron Pharmaceuticals88
招募中
1 期
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic DermatitisAtopic DermatitisHealthy VolunteerNCT07527923Regeneron Pharmaceuticals144
招募中
2 期
Study of REGN13335 in Adult Participants With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial Hypertension (PAH)NCT07318597Regeneron Pharmaceuticals99
尚未招募
1 期
A Study to Evaluate the Safety and Tolerability of Intravenous Stemis™ in Elderly Subjects With Mild to Moderate Frailty SyndromeFrailty SyndromeNCT07462819Ji Yan Biomedical Co., Ltd.12
招募中
3 期
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial FibrillationAtrial Fibrillation (AF)NCT07626411Regeneron Pharmaceuticals15,364