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

Phase 1

• Conditions: MedDRA version: 26.0Level: LLTClassification code 10051615Term: Atherosclerotic cardiovascular diseaseSystem Organ Class: 10047065 - Vascular disorders; Atherosclerotic cardiovascular disease; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2021-005855-35-BG
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-27
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 7000

Inclusion Criteria

Male or female
- Age above or equal to 55 years at the time of signing informed consent.
- Body mass index (BMI) above or equal 25.0 kg/m^2
- 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) below
0.85 at rest
b. Intermittent claudication with a above or equal 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) above or equal to 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
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 3000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4000

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 below 15 mL/min/1.73 m^2, 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

Primary Outcome Measures

Name	Time	Method
Main Objective: To confirm non-inferiority of CagriSema 2.4 mg/2.4 mg versus placebo with respect to time to first major adverse cardiovascular event (MACE).;Secondary Objective: - To confirm superiority of CagriSema 2.4 mg/2.4 mg versus placebo with respect to time to first MACE.<br>- To compare the effect of CagriSema 2.4 mg/2.4 mg versus placebo on:<br>a. CV outcomes<br>b. CV risk factors<br>c. Body weight<br>d. Glucose metabolism<br>e. SF-36v2 physical and mental components of health<br>- To compare the safety and tolerability of CagriSema 2.4 mg/2.4 mg<br>versus placebo<br>- To compare the effect of CagriSema 2.4 mg/2.4 mg versus placebo on:<br>a. Biomarkers linked to CV risk and inflammation<br>b. Painful and painless peripheral neuropathy;Primary end point(s): 1. Time to first occurrence of MACE, a composite endpoint consisting of: CV death, non-fatal myocardial infarction, non-fatal stroke;Timepoint(s) of evaluation of this end point: 1. From baseline (week 0) to end of study (up to 242 weeks or more)