REDEFINE 3: A research study to see the effects of CagriSema in people living with diseases in the heart and blood vessels

Phase 1

• Conditions: Cardiovascular disease; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: CTIS2023-506924-94-00
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-16
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 5054

Inclusion Criteria

Male or female, Age above or equal to 55 years at the time of signing informed consent, Body mass index (BMI) = 25.0 kg/m2, Established CVD as evidenced by at least one of the following: •Prior myocardial infarction •Prior stroke (ischemic or haemorrhagic stroke) •Symptomatic peripheral arterial disease (PAD) defined as at least one of the following: a.Intermittent claudication with an ankle-brachial index (ABI) < 0.85 at rest b.Intermittent claudication with a = 50% stenosis in a lower extremity peripheral artery documented by X-ray angiography, MR angiography, CT angiography or Doppler ultrasound c.Prior revascularization procedure of a lower extremity peripheral artery d.Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g., trauma or osteomyelitis), For participants with T2D at screening, the following inclusion criteria also apply: Diagnosed with type 2 diabetes mellitus (T2D) = 180 days before screening. HbA1c 6.5%-10% (48-86 mmol/mol) (both inclusive), as measured by central laboratory at screening. Treatment with either: a.Lifestyle intervention alone b.1-3 marketed oral antidiabetic drugs (OADs) (metformin, a-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i), DPP4-inhibitors, thiazolidinediones, or sulphonylureas (SU) as a single agent or in combination) according to local label c.Basal insulin alone or in combination with up to two marketed OADs (refer to b. above), all according to local label

Exclusion Criteria

Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 60 days before screening, Planned coronary, carotid or peripheral artery revascularisation known on the day of screening, Heart failure classified as being in New York Heart Association (NYHA) Class IV at screening, Treatment with any GLP-1 RA or a medication with GLP-1 activity within 90 days before screening, End stage renal disease defined as eGFR < 15 mL/min/1.73 m2, as measured by the central laboratory at screening, Chronic or intermittent haemodialysis or peritoneal dialysis

Study & Design

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