Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in East Asian People Who Are Overweight or Living With Obesity
- Conditions
- Overweight and Obesity
- Interventions
- Drug: placebo (semaglutide)Drug: semaglutide 50 mg
- Registration Number
- NCT05132088
- Lead Sponsor
- Novo Nordisk A/S
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 201
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description oral semaglutide placebo once daily placebo (semaglutide) All participants will get semaglutide or placebo tablets, 1 tablet every morning. oral semaglutide 50 mg once daily semaglutide 50 mg All participants will get semaglutide or placebo tablets, 1 tablet every morning.
- Primary Outcome Measures
Name Time Method Relative change in body weight From baseline (week 0) to end of treatment (week 68) Percentage-point
Achievement of body weight reduction greater than or equal to 5% (Yes/No) At end of treatment (week 68) Count of participants
- Secondary Outcome Measures
Name Time Method Achievement of body weight reduction greater than or equal to 10% (Yes/No) At end of treatment (week 68) Count of participants
Change in Physical function domain (5-items) score (IWQOL-Lite-CT) From baseline (week 0) to end of treatment (week 68) Score points
Achievement of body weight reduction greater than or equal to 15% (Yes/No) At end of treatment (week 68) Count of participants
Achievement of body weight reduction greater than or equal to 20% (Yes/No) At end of treatment (week 68) Count of participants
Change in body mass index (BMI) From baseline (week 0) to end of treatment (week 68) Count of participants
Change in waist circumference measured according to the JASSO guideline From baseline (week 0) to end of treatment (week 68) Messured in CM
Change in Visceral Fat Area (VFA) measured by CT scan in a subset of the Japanese study population From baseline to end of treatment (week 68) Messured in cm\^2
Change in systolic blood pressure From baseline (week 0) to end of treatment (week 68) Messured in mmHg
Change in diastolic blood pressure From randomisation (week 0) to end of treatment (week 68) Messured in mmHg
Change in glycated haemoglobin (HbA1c) From baseline (week 0) to end of treatment (week 68) %-point
Change in lipids: low-density lipoprotein (LDL) cholesterol From baseline (week 0) to end of treatment (week 68) Ratio to baseline
Change in lipids: Total cholesterol From baseline (week 0) to end of treatment (week 68) Ratio to baseline
Change in lipids: high density lipoprotein (HDL) cholesterol From baseline (week 0) to end of treatment (week 68) Ratio to baseline
Change in lipids: very-low density lipoprotein (VLDL) cholesterol From baseline (week 0) to end of treatment (week 68) Ratio to baseline
Change in lipids: Triglycerides From baseline (week 0) to end of treatment (week 68) Ratio to baseline
Change in lipids: Free fatty acids From baseline (week 0) to end of treatment (week 68) Ratio to baseline
Change in high sensitivity C Reactive Protein From baseline (week 0) to end of treatment (week 68) Ratio to baseline
Number of treatment emergent adverse events From baseline (week 0) to end of study (week 75) Count of events
Number of serious adverse events From baseline (week 0) to end of study (week 75) Count of events
Trial Locations
- Locations (13)
Naka Kinen Clinic
🇯🇵Ibaraki, Japan
ToCROM Clinic
🇯🇵Tokyo, Japan
Osaka University Hospital
🇯🇵Osaka, Japan
OCROM Clinic
🇯🇵Suita-shi, Osaka, Japan
Iryouhoujinsyadan Shoureikan Shinsapporo Seiryou Hospital
🇯🇵Sapporo city, Hokkaido, Japan
Tsuruma Kaneshiro Diabetes Clinic
🇯🇵Yamato-shi, Kanagawa, Japan
Tokyo Center Clinic
🇯🇵Tokyo, Japan
Toranomon Hospital, Endocrinology and Metabolism
🇯🇵Minato-ku, Tokyo, Japan
Seoul National University Bundang Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Takatsuki Red Cross Hospital
🇯🇵Osaka, Japan