NCT07815067尚未招募1 期
Investigating the Effect of Post-dose Meal Timings and Water Volume at Dosing on the Pharmacokinetic Properties of Oral Zenagamtide in 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
- 尚未招募
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- AUC, zenagamtide, steady state (ss): area under the zenagamtide plasma concentration-time curve during a dosing interval at steady state
研究概览
简要总结
The purpose of this clinical study is to test how taking zenagamtide tablets with different meal/water variations affects how much zenagamtide enters the bloodstream in people who have overweight or obesity. All participants will get zenagamtide.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female (sex assigned at birth, inclusive of all gender identities).
- •Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
排除标准
- •Known or suspected hypersensitivity to study intervention(s) or related products.
- •Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- •Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, or as judged by the investigator.
- •Unusual meal habits (including, but not limited to, eating disorders) and special diet
- •HbA1c more than or equal to (≥) 6.5 percent (%) [48 (nanomoles per mole) mmol/mol] at screening.
研究组 & 干预措施
Zenagamtide subcutaneous (s.c.)
Experimental
Participants will receive one of the different dose levels of zenagamtide once weekly subcutaneously.
干预措施: Zenagamtide injection (Drug)
Zenagamtide oral
Experimental
Participants will receive oral dose of zenagamtide once daily.
干预措施: Zenagamtide tablet (Drug)
结局指标
主要结局
AUC, zenagamtide, steady state (ss): area under the zenagamtide plasma concentration-time curve during a dosing interval at steady state
时间窗: From 0 (pre-dose) up to Day 196 and Day 224
Measured as nanomoles per liter hourly (h\*nmol/L)
次要结局
- Cmax, zenagamtide, ss: maximum observed plasma concentration of zenagamtide at steady state(From Day 196 to Day 197 and from Day 224 to Day 225)
- tmax, zenagamtide, ss: the time to maximum observed plasma concentration of zenagamtide at steady state(From Day 196 to Day 197 and from Day 224 to Day 225)
- t1/2, ss; the terminal half-life of zenagamtide after the last dose(From pre-dose on Day 224 until completion of Day 252)
研究者
研究点 (1)
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