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過体重または肥満の東アジア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

基本情報

NCT ID
NCT05132088
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
201
治験依頼者名
Novo Nordisk A/S

概要

Novo Nordisk are doing this study 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 healthcare professional. Blood samples will be taken at 12 visits. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period. If participants are a woman and are able to become pregnant, participants will be checked for pregnancy via urine tests.

対象疾患

Overweight and Obesity

介入

semaglutide 50 mg(DRUG)
placebo (semaglutide)(DRUG)

依頼者(Sponsor)

実施施設 (9)

国家公務員共済組合連合会 虎の門病院

Minato-ku, Tokyo, Japan

医療法人平心会 ToCROMクリニック

Tokyo, Japan

OCROM Clinic

Suita-shi, Osaka, Japan

Iryouhoujinsyadan Shoureikan Shinsapporo Seiryou Hospital

Sapporo, Hokkaido, Japan

鶴間かねしろ内科クリニック

Yamato-shi, Kanagawa, Japan

Naka Kinen Clinic

Ibaraki, Japan

高槻赤十字病院

Osaka, Japan

医療法人社団知正会 東京センタークリニック

Tokyo, Japan

大阪大学医学部附属病院

Osaka, Japan