A research study to see how well CagriSema helps people losing weight in people who have a body weight above the healthy range and type 2 diabetes

Phase 1

• Conditions: Overweight, Obesity and Diabetes Mellitus, Type 2; MedDRA version: 24.1Level: PTClassification code 10033307Term: OverweightSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 20.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2021-005121-24-HU
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-31
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

- Male or female
- Age above or equal to 18 years at the time of signing informed consent
- BMI greater than or equal to 27.0 kg/m^2
- Diagnosed with type 2 diabetes mellitus for180 days or more before screening
- Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic
drugs (OAD)s (metformin, a-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter
2 inhibitor (SGLT2i), thiazolidinediones, or sulphonylureas (SU)s as a single
agent or in combination) according to local label
- Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing
frequency) for at least 90 days before screening
- HbA1c 7%-10% (53-86 mmol/mol) (both inclusive) as measured by the 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 946
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 254

Exclusion Criteria

Diabetes related:
- Clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness
- Renal impairment with estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m^2, as measured by the central laboratory at screening
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

Study & Design

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