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COMPLETED
NCT05132088
PHASE3

Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in East Asian People Who Are Overweight or Living With Obesity

Sponsor: Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

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.

Official title: Efficacy and Safety of Oral Semaglutide 50 mg Once Daily in East Asian Participants With Overweight or Obesity

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

201

Start Date

2021-11-16

Completion Date

2023-09-01

Last Updated

2026-08-14

Healthy Volunteers

No

Interventions

DRUG

semaglutide 50 mg

Participants will have semaglutide for 68 weeks and will have 1 tablet every morning. Dose gradually increased to 50 mg.

DRUG

placebo (semaglutide)

Participants will have placebo tablets for 68 weeks and will have 1 tablet every morning.

Locations (15)

Shinsapporo Seiryou Hospital_General Clinical Department

Sapporo, Hokkaido, Japan

Tsuruma Kaneshiro Diabetes Clinic_Internal medicine

Yamato-shi, Kanagawa, Japan

OCROM Clinic_Internal medicine

Suita-shi, Osaka, Japan

Naka Kinen Clinic_Internal medicine

Ibaraki, Japan

Toranomon Hospital, Endocrinology and Metabolism

Minato-ku, Tokyo, Japan

The University of Osaka Hospital_Metabolic Medicine

Osaka, Japan

Takatsuki Red Cross Hospital_Diabetes and Endocrine Div.

Osaka, Japan

Takatsuki Red Cross Hospital

Osaka, Japan

Tokyo Center Clinic_Internal Medicine

Tokyo, Japan

Tokyo Center Clinic

Tokyo, Japan

ToCROM Clinic_Internal Medicine

Tokyo, Japan

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Kyungpook National University Hospital

Daegu, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Kangbuk Samsung Hospital

Seoul, South Korea