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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
201
Participants will have semaglutide for 68 weeks and will have 1 tablet every morning. Dose gradually increased to 50 mg.
Participants will have placebo tablets for 68 weeks and will have 1 tablet every morning.
Iryouhoujinsyadan Shoureikan Shinsapporo Seiryou Hospital
Sapporo, Hokkaido, Japan
Tsuruma Kaneshiro Diabetes Clinic
Yamato-shi, Kanagawa, Japan
OCROM Clinic
Suita-shi, Osaka, Japan
Naka Kinen Clinic
Ibaraki, Japan
Toranomon Hospital, Endocrinology and Metabolism
Minato-ku, Tokyo, Japan
Osaka University Hospital
Osaka, Japan
Takatsuki Red Cross Hospital
Osaka, Japan
Tokyo Center Clinic
Tokyo, Japan
ToCROM Clinic
Tokyo, Japan
Kyungpook National University Hospital
Daegu, South Korea
...and 3 more locations
Relative change in body weight
Percentage-point
Time frame: From baseline (week 0) to end of treatment (week 68)
Achievement of body weight reduction greater than or equal to 5% (Yes/No)
Count of participants
Time frame: At end of treatment (week 68)
Achievement of body weight reduction greater than or equal to 10% (Yes/No)
Count of participants
Time frame: At end of treatment (week 68)
Change in Physical function domain (5-items) score (IWQOL-Lite-CT)
Score points
Time frame: From baseline (week 0) to end of treatment (week 68)
Achievement of body weight reduction greater than or equal to 15% (Yes/No)
Count of participants
Time frame: At end of treatment (week 68)
Achievement of body weight reduction greater than or equal to 20% (Yes/No)
Count of participants
Time frame: At end of treatment (week 68)
Change in body mass index (BMI)
Count of participants
Time frame: From baseline (week 0) to end of treatment (week 68)
Change in waist circumference measured according to the JASSO guideline
Messured in CM
Time frame: From baseline (week 0) to end of treatment (week 68)
Change in Visceral Fat Area (VFA) measured by CT scan in a subset of the Japanese study population
%-point
Time frame: From baseline to end of treatment (week 68)
Change in Visceral Fat Area (VFA) measured by CT scan in a subset of the Japanese study population
Messured in cm\^2
Time frame: From baseline to end of treatment (week 68)
Change in systolic blood pressure
Messured in mmHg
Time frame: From baseline (week 0) to end of treatment (week 68)
Change in diastolic blood pressure
Messured in mmHg
Time frame: From randomisation (week 0) to end of treatment (week 68)
Change in glycated haemoglobin (HbA1c)
%-point
Time frame: From baseline (week 0) to end of treatment (week 68)
Change in lipids: Total cholesterol
Ratio to baseline
Time frame: From baseline (week 0) to end of treatment (week 68)
Change in lipids: high density lipoprotein (HDL) cholesterol
Ratio to baseline
Time frame: From baseline (week 0) to end of treatment (week 68)
Change in lipids: low-density lipoprotein (LDL) cholesterol
Ratio to baseline
Time frame: From baseline (week 0) to end of treatment (week 68)
Change in lipids: very-low density lipoprotein (VLDL) cholesterol
Ratio to baseline
Time frame: From baseline (week 0) to end of treatment (week 68)
Change in lipids: Triglycerides
Ratio to baseline
Time frame: From baseline (week 0) to end of treatment (week 68)
Change in lipids: Free fatty acids
Ratio to baseline
Time frame: From baseline (week 0) to end of treatment (week 68)
Change in high sensitivity C Reactive Protein
Ratio to baseline
Time frame: From baseline (week 0) to end of treatment (week 68)
Number of treatment emergent adverse events
Count of events
Time frame: From baseline (week 0) to end of study (week 75)
Number of serious adverse events
Count of events
Time frame: From baseline (week 0) to end of study (week 75)
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