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栄養失調リスクのある高齢者を含む高齢者を対象としたPF-07258669と呼ばれる研究薬について知るための研究

基本情報

NCT ID
NCT07086664
ステータス
実施中(募集終了)
試験のフェーズ
第1相
試験タイプ
介入
目標被験者数
7
治験依頼者名
Pfizer

概要

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

対象疾患

Healthy Volunteers

介入

Placebo(DRUG)
PF-07258669(DRUG)

依頼者(Sponsor)

実施施設 (4)

順天堂大学医学部附属 順天堂東京江東高齢者医療センター

Koto-ku, Tokyo, Japan

医療法人徳洲会湘南藤沢徳洲会病院

Fujisawa, Kanagawa, Japan

医療法人徳洲会 八尾徳洲会総合病院

Yao Shi, Osaka, Japan

医療法人徳洲会 山形徳洲会病院

Yamagata, Japan