The cardiovascular safety of efficacy cagrilintide 2.4 mg s.c. in combination with semaglutide 2.4 mg s.c. (CagriSema 2.4 mg/2.4 mg s.c.) once-weekly in participants established cardiovascular disease

Phase 3

Recruiting

• Conditions: cardiovascular disease; 10082206

• Registration Number: NL-OMON55925
• Lead Sponsor: ovo Nordisk

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 160

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/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) 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 (OAD)s (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 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
• Study Design: Not specified