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: - Age greater than or equal to 18 years at the time of signing the informed consent - Female subject of non-childbearing potential or Male subject who is surgically sterilised (vasectomy) or who is willing to use adequate contraceptive methods (as required by local regulation or practice) throughout the trial (until ‘end of trial’) - Body mass index (BMI) greater than or equal to 30.0 kg/m^2 or BMI greater than or equal to 27.0 kg/m^2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension or dyslipidaemia (to be assessed at the investigator’s discretion) 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 650 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: - Glycated haemoglobin (HbA1c) greater than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening - A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days prior to screening irrespective of medical records
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the dose-response of increasing doses of NNC0174-0833 once weekly (OW) versus placebo and versus liraglutide 3.0 mg once daily (OD) on body weight, in subjects with overweight or obesity, when added as an adjunct to a reduced-calorie diet and increased physical activity;Secondary Objective: To compare the effect of NNC0174-0833 OW versus placebo and versus liraglutide 3.0 mg OD, when added as an adjunct to a reduced-calorie diet and increased physical activity, on: - Change in waist circumference - Change in glycaemic parameters - Safety and tolerability;Primary end point(s): Change in body weight (%);Timepoint(s) of evaluation of this end point: From randomisation at week 0 to week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Subjects who achieve (yes/no) body weight reduction more than or equal to 5% from randomisation 2. Change in HbA1c (%-point, mmol/mol) 3. Number of treatment emergent adverse events (TEAEs);Timepoint(s) of evaluation of this end point: 1. After 26 weeks 2. From randomisation at week 0 to week 26 3. From randomisation at week 0 to week 32 (‘end of trial’) | — |
Countries
Canada, Denmark, European Union, Finland, Japan, Poland, Serbia, South Africa, United Kingdom, United States
Contacts
Public ContactClinical Disclosure (1452)
Novo Nordisk A/S
Outcome results
None listed