Research study investigating how well NNC0174-0833 works in people suffering from overweight or obesity

Phase 1

• Conditions: ObesityOverweight; MedDRA version: 20.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 20.0Level: PTClassification code 10033307Term: OverweightSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2018-001945-14-FI
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-09
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 700

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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,<br>when added as an adjunct to a reduced-calorie diet and increased physical activity, on:<br>- Change in waist circumference<br>- Change in glycaemic parameters<br>- 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 Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Subjects who achieve (yes/no) body weight reduction more than or equal to 5% from randomisation <br>2. Change in HbA1c (%-point, mmol/mol)<br>3. Number of treatment emergent adverse events (TEAEs);Timepoint(s) of evaluation of this end point: 1. After 26 weeks <br>2. From randomisation at week 0 to week 26 <br>3. From randomisation at week 0 to week 32 (‘end of trial’)