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肥満成人におけるPF-06882961の有効性および安全性を評価する研究

基本情報

NCT ID
NCT04707313
ステータス
完了
試験のフェーズ
第2相
試験タイプ
介入
目標被験者数
628
治験依頼者名
Pfizer

概要

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-06882961) for the potential treatment of obesity. The study will compare the experiences of participants taking the study medicine (PF-06882961) to those of participants who take placebo (a look- alike 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, waist and hip measurements, how well they tolerate the study medicine, and to measure levels of the study medicine in participants' blood. This study is seeking participants who have obesity, who do not have diabetes and who have had a stable body weight and not participated in a formal weight loss program in the 90 days before the study. The study medicine or placebo will be taken as tablets by mouth 2 times a day (1 time in the morning and 1 time in the evening). There are 3 groups of participants (called cohorts) in this study. For participants in Cohorts 1 and 2, total study participation will be about 9 months, with 15 planned study visits (14 visits to the study clinic and 1 telephone call). For participants in Cohort 3, total study participation will be about 10 months, with 21 planned study visits (12 visits to the study clinic and 9 telephone calls).

対象疾患

Obesity

介入

Placebo (Cohorts 1 and 2)(DRUG)
PF-06882961 (Cohorts 1 and 2)(DRUG)
Placebo (Cohort 3)(DRUG)
PF-06882961 (Cohort 3)(DRUG)

依頼者(Sponsor)

実施施設 (4)

医療法人平心会 ToCROMクリニック

Suita-shi, Osaka, Japan

Medical Corporation Heishinkai ToCROM Clinic

Shinjuku-ku, Tokyo, Japan

医療法人社団福和会 福和クリニック

Chuo-ku, Tokyo, Japan

医療法人社団知正会 東京センタークリニック

Chuo-ku, Tokyo, Japan