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临床试验/NCT07731139
NCT07731139尚未招募1 期

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO INVESTIGATE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF MULTIPLE ASCENDING ORAL DOSES OF PF-08642534 IN ADULTS WITH OBESITY

Pfizer1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年7月28日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
尚未招募
发起方
Pfizer
入组人数
120
试验地点
1
主要终点
Incidence of treatment emergent adverse events (TEAE)

研究概览

简要总结

This study will look at a study drug called PF-08642534 in people with obesity (have too much body weight) to see: if participants can take different amounts (doses) of the study drug in a safe way and how adults with obesity tolerate it, and how the body handles the study drug (for example, how the study drug is absorbed and removed from the body).

People who want to join the study will first go through a screening period of up to 4 weeks. Doctors will check if each person meets the study conditions, including age, body weight, and general health. People with certain medical conditions will not be able to take part in the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Body mass index (BMI) ≥30.0 and ≤40.0 kg/m², and with stable body weight prior to screening.
  • Participants are generally otherwise healthy but may have mild chronic conditions (eg, dyslipidemia or hypertension)

排除标准

  • - Individuals with diabetes, significant cardiovascular, hepatic, renal, gastrointestinal, or psychiatric disorders, or conditions that may affect drug absorption or metabolism, are not eligible to participate.

结局指标

主要结局

Incidence of treatment emergent adverse events (TEAE)

时间窗: Baseline up to 8 weeks after last dose

次要结局

  • Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-08642534(0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24 hours post-dose)
  • Maximum Observed Plasma Concentration (Cmax) of PF-08642534(0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24 hours post-dose)

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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