A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE-RANGING STUDY OF PF-07976016 TO ASSESS SAFETY AND EFFICACY IN ADULT PARTICIPANTS WITH OBESITY

Pfizer74 个研究点分布在 3 个国家目标入组 263 人2024年12月9日

适应症Obesity

干预措施PF-07976016 Placebo

概览

阶段: 2 期
干预措施: PF-07976016
疾病 / 适应症: Obesity
发起方: Pfizer
入组人数: 263
试验地点: 74
主要终点: Percent change from baseline in body weight
状态: 已完成
最后更新: 2个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07976016) for the potential treatment of obesity. The study will compare the experiences of participants taking the study medicine (PF-07976016) to those of participants who take placebo (a lookalike substance that contains no active study medicine). The aim is to measure the body's response to the study medicine, including any changes in participants' body weight and how well they tolerate the study medicine.

注册库

clinicaltrials.gov

开始日期

2024年12月9日

结束日期

2026年1月12日

最后更新

2个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Pfizer

责任方

Sponsor

入排标准

入选标准

•Male or non-pregnant, non-breastfeeding female, 18 to 74 years of age at Visit 1
•Body Mass Index ≥30.0 kg/m2 at Visit 1, with stable body weight, defined as \<5 kg change in the 12 weeks before Visit 1
•Eligible and willing to receive required background medicine
•Willing and able to comply with all study procedures

排除标准

•Any medical or psychiatric condition or laboratory abnormality, or recent serious illness or hospitalization, that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study including diagnosis of type 2 diabetes mellitus, type 1 or secondary forms of diabetes.
•Use of any prohibited prior or concomitant medication(s)
•Presence of specified abnormalities on diagnostic assessments including clinical laboratory tests at Visit 1.

研究组 & 干预措施

PF-07976016 Dose 1

干预措施: PF-07976016

PF-07976016 Dose 2

干预措施: PF-07976016

PF-07976016 Dose 3

干预措施: PF-07976016

Placebo

干预措施: Placebo

结局指标

主要结局

Percent change from baseline in body weight

时间窗: Baseline to Week 16

次要结局

Number of participants with treatment emergent adverse events(From first dose (Day 1) up to 28-35 days after final dose, a total of approximately 21 weeks)