Obesity MedDRA version: 20.0 Level: PT Classification code 10029883 Term: Obesity 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 aged above or equal to 18 years at the time of signing informed consent. - BMI greater than or equal to 30.0 kg/m^2 - Prediabetes defined as at least one of the following: a) HbA1c between 6.0 and 6.4 % (42 and 47 mmol/mol) (both inclusive) as measured by central laboratory at screening. b) FPG between 5.5 and 6.9 mmol/L (99 and 125 mg/dL) (both inclusive) as measured by central laboratory at screening. 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 185 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
Exclusion criteria: - History of type 1 or type 2 diabetes. - Treatment with glucose-lowering agent(s) within 90 days before screening. - HbA1c greater than or equal to 6.5 % (greater than or equal to 48 mmol/mol) as measured by central laboratory at screening. - FPG greater than or equal to 7.0mmol/L (126 mg/dL) as measured by 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. - Treatment with any medication for the indication of obesity within the past 90 days before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the superiority of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo, both as adjuncts to a reduced-calorie diet and increased physical activity in subjects with obesity and prediabetes, on body weight and reversal to normoglycemia.;Secondary Objective: 1. To compare the efficacy of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo on: • glucose metabolism • cardiovascular risk factors • other factors related to body weight 2. To compare the safety and tolerability of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo.;Primary end point(s): 1. Change in body weight 2. Change to normoglycemia (Normoglycemia is defined as having both HbA1c below 6.0% (below 42 mmol/mol) and FPG below 5.5 mmol/L (below 99 mg/dL);Timepoint(s) of evaluation of this end point: 1.-2. From randomisation (week 0) to end of treatment (week 52) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in HbA1c 2. Change in FPG 3. Change in waist circumference 4. Change in systolic blood pressure 5. Change in lipids: a) Triglycerides b)Total cholesterol c) High density lipoprotein (HDL) cholesterol d) Low density lipoprotein (LDL) cholesterol e) Very low density lipoprotein (VLDL) cholesterol;Timepoint(s) of evaluation of this end point: 1.-5. From randomisation (week 0) to end of treatment (week 52) | — |
Countries
Canada, Denmark, European Union, Finland, Spain, United Kingdom
Contacts
Public ContactClinical Transparency (1452)
Novo Nordisk A/S
Outcome results
None listed