Obesity Overweight MedDRA version: 20.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 20.0 Level: PT Classification code 10033307 Term: Overweight System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female, age greater than or equal to 18 years at the time of signing informed consent - Body mass index (BMI): greater than or equal to 27.0 kg/m^2 with the presence of at least one of the following weight-related complications (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease OR greater than or equal to 30.0 kg/m^2 - History of at least one self-reported unsuccessful dietary effort to lose body weight Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 160
Exclusion criteria
Exclusion criteria: - HbA1c greater than or equal to 6.5% (48 mmol/mol) as measured by the central laboratory at screening - A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm superior efficacy on body weight reduction of oral semaglutide 50 mg once daily versus placebo as an adjunct to reduced-calorie diet and increased physical activity in subjects with overweight or obesity.;Secondary Objective: - To confirm superior efficacy on physical function of oral semaglutide 50 mg once daily versus placebo as an adjunct to reduced-calorie diet and increased physical activity in subjects with overweight or obesity. -To estimate the efficacy on cardio-metabolic parameters of oral semaglutide 50 mg once daily versus placebo as an adjunct to reduced-calorie diet and increased physical activity in subjects with overweight or obesity. -To compare the safety and tolerability of oral semaglutide 50 mg once daily versus placebo as an adjunct to reduced-calorie diet and increased physical activity in subjects with overweight or obesity.;Primary end point(s): 1. Relative change in body weight 2. Achievement of body weight reduction greater than or equal to 5% (Yes/No);Timepoint(s) of evaluation of this end point: 1. From baseline (week 0) to end of treatment (week 68) 2. At end-of-treatment (week 68) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Achievement of body weight reduction greater than or equal to 10% 2. Change in Short Form-36 (SF-36) Physical Function 3. Change in IWQOL-Lite-CT Physical Function 4. Change in waist circumference 5. Achievement of body weight reduction greater than or equal to 15% (Yes/No) 6. Achievement of body weight reduction greater than or equal to 20% (Yes/No) 7. Change in body mass index (BMI) 8. Change in systolic blood pressure 9. Change in diastolic blood pressure 10. Change in HbA1c 11. Change in fasting plasma glucose (FPG) 12. Change in fasting serum insulin 13. Change in lipids: Total cholesterol 14. Change in lipids: HDL cholesterol 15. Change in lipids: LDL cholesterol 16. Change in lipids: VLDL cholesterol 17. Change in lipids: Triglycerides 18. Change in lipids: Free fatty acids 19. Change in high sensitivity C-Reactive Protein 20. Number of treatment emergent adverse events 21. Number of serious adverse events;Timepoint(s) of evaluation of this end point: 1. and 5.-6. At end of treatment (week 68) 2.- 4. and 7.-1 9. From baseline (week 0) to end of treatment (week 68) 20.-21. From baseline (week 0) to end-of-trial (week 75) | — |
Countries
Canada, Denmark, European Union, Finland, France, Japan, Russian Federation, United States
Contacts
Public ContactClinical Transparency (1452)
Novo Nordisk A/S
Outcome results
None listed