REDEFINE 1: A research study to see how well CagriSema helps people losing weight in people who have a body weight above the healthy range

Phase 1

• Conditions: Obesity, Overweight; MedDRA version: 20.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 24.1Level: PTClassification code 10033307Term: OverweightSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2020-005435-75-DK
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-07
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3400

Inclusion Criteria

- Male or female
- Age above or equal to 18 years at the time of signing informed consent
- a) BMI greater than or equal to 30.0 kg/m^2 or b) BMI greater than or equal to 27.0 kg/m^2 with the presence of at least one obesity related complication including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
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 3128
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 272

Exclusion Criteria

Glycaemia related:
-HbA1c greater than or equal to 6.5 % (48 mmol/mol) as measured by the central laboratory at screening
-History of type 1 or type 2 diabetes mellitus

Study & Design

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