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過体重または肥満の人におけるセマグルチド錠の1日1回服用の効果を調査する研究調査(OASIS 1)

基本情報

NCT ID
NCT05035095
ステータス
完了
試験のフェーズ
第3相
試験タイプ
介入
目標被験者数
667
治験依頼者名
Novo Nordisk A/S

概要

This study is being conducted to see if semaglutide tablets can be used as a treatment to help people living with overweight or obesity lose weight. This study will look at the change in participants body weight. Participants will either get semaglutide tablets (new medicine) or placebo tablets ('dummy' medicine that looks like semaglutide but has no effect on the body). For a fair comparison, people are divided into two groups at random by a computer. This process is called randomisation. Semaglutide tablets are new medicine being tested to treat overweight and obesity. Doctors in many countries can already prescribe semaglutide tablets at lower doses to treat type 2 diabetes. Participants will get semaglutide or placebo tablets for 68 weeks and will need to take 1 tablet every morning In addition to taking the medicine, participants will have talks with study staff about: * healthy food choices * how to be more physically active * what participants can do to lose weight The study will last for about 1½ year.Participants will have 14 clinic visits and 7 phone calls with the study doctor. Blood samples will be taken at 10 visits. Participants will have a test to check their heart done at 3 visits. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. If participant is a woman and is able to become pregnant, participant will be checked for pregnancy via urine tests.

対象疾患

ObesityOverweight

介入

Oral semaglutide(DRUG)
Placebo (semaglutide)(DRUG)

依頼者(Sponsor)

実施施設 (3)

医療法人社団慶幸会 東新宿クリニック

Tokyo, Japan

水道橋メディカルクリニック

Chiyoda-ku, Tokyo, Japan

千葉大学医学部附属病院

Chiba-shi, Chiba, Japan