NCT06717425已完成2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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
研究概览
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.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
Experimental
干预措施: PF-07976016 (Drug)
PF-07976016 Dose 2
Experimental
干预措施: PF-07976016 (Drug)
PF-07976016 Dose 3
Experimental
干预措施: PF-07976016 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
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)
研究者
研究点 (74)
Loading locations...
相似试验
已完成
1 期
A Study to Learn How the Study Medicine Called PF-07275315 Works in Healthy PeopleHealthy VolunteersNCT05411588Pfizer65
已完成
1 期
A Study to Learn About the Study Medicine Called PF-07905428 in Healthy Participants and Participants With Acne VulgarisAcne VulgarisNCT06671834Pfizer52
已完成
2 期
A Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With ObesityObesityNCT04707313Pfizer628
已完成
1 期
A Study to Learn About the Study Medicine Called PF-07054894 in People of Japanese OriginHealthyNCT06327880Pfizer6
招募中
2 期
Assessing Administration of pBI-11 Via Electroporation for the Treatment of Patients With HPV16/18+HPV InfectionNCT06210854Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins48