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

Phase 1

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

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-18
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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