An Interventional Phase 1b, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Pharmacodynamic Effect of PF-07258669 Compared to Placebo in Older Participants Including Those at Risk of Malnutrition
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 7
- 试验地点
- 14
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events
研究概览
简要总结
The purpose of this study is to look at safety, tolerability, and pharmacodynamic effects (i.e. how the study drug affects your body) of PF-07258669 in older participants ((60 years to <90 years) including those at risk of malnutrition.
The study medicine PF-07258669 is being developed for the treatment of unintended weight loss in older adults. People with this condition have decreased appetite and food intake, which is an important reason for poor nutrition and health results in people with unintended weight loss.
This is approximately a 26-week-long study with 9 visits to the study doctor and 4 telehealth visits (ie. visits by phone call). The study will include
- Screening period for up to 4 weeks
- Pre-treatment period of 2 weeks
- Treatment period of 16 weeks : study drug (PF-07258669 or matching placebo)
- Follow-up period of 4 weeks The study requires answering questionnaires and use of digital devices at home to measure blood pressure and physical activity. The study team will monitor how each participant is doing during the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are 60 years to <90 years Are males or females who can no longer have children Have Body weight ≥40 kg and Body mass index (BMI) ≤25 kg/m2
排除标准
- •Evidence or history of clinically significant medical conditions. Positive for active, untreated HIV, hepatitis B, and/or hepatitis C History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
- •Voluntary diet restriction or eating disorder
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
PF-07258669
干预措施: PF-07258669 (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events
时间窗: Baseline to Week 20
次要结局
- Percent change from baseline in body weight(Baseline to Week 16)