Summary

Eligibility
for people ages 55 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

Summary

This study will look at the effects of CagriSema on cardiovascular events (for example heart attack and stroke) in people living with cardiovascular disease. Participants will either get CagriSema or a dummy medicine (also called "placebo") which has no effect on the body. Which treatment participants will get will be decided by chance. Participant's chance of getting CagriSema or placebo is the same. Participants will inject the study medicine once a week. The study medicine will be injected briefly with a thin needle, typically in the stomach, thighs or upper arms. The study will last for up to 4.5 years.

Official Title

The Cardiovascular Safety and Efficacy of 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 With Established Cardiovascular Disease

Keywords

Cardiovascular Disease, Cardiovascular Diseases, Semaglutide, Cagrilintide, CagriSema 2.4 mg/2.4 mg

Eligibility

You can join if…

Open to people ages 55 years and up

  • Male or female
  • Age above or equal to 55 years at the time of signing informed consent
  • Body mass index (BMI) greater than or equal to (>=) 25.0 kilograms per meter square (kg/m2)
  • Established CVD as evidenced by at least one of the following:
    1. Prior myocardial infarction
    2. Prior stroke (ischemic or haemorrhagic stroke)
    3. Symptomatic peripheral arterial disease (PAD) defined as at least one of the following:
      1. Intermittent claudication with an ankle-brachial index (ABI) less than (<) 0.85 at rest
      2. Intermittent claudication with a >= 50% stenosis in a lower extremity peripheral artery documented by X-ray angiography, magnetic resonance (MR) angiography, computed tomography (CT) angiography or Doppler ultrasound
      3. Prior revascularization procedure of a lower extremity peripheral artery
      4. 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 millimoles per mole [mmol/mol]) (both inclusive), as measured by central laboratory at screening
  • Treatment with either:
    1. Lifestyle intervention alone
    2. 1-3 marketed oral antidiabetic drugs (OADs) (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i), dipeptidyl peptidase 4 (DPP4)-inhibitors, thiazolidinediones, or sulphonylureas (SU) as a single agent or in combination) according to local label
    3. Basal insulin alone or in combination with up to two marketed OADs, all according to local label

You CAN'T join if...

  • 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 glucagon-like peptide-1 (GLP-1) receptor agonist (RA) or a medication with GLP-1 activity within 90 days before screening
  • End stage renal disease defined as estimated glomerular filtration rate (eGFR) < 15 millileters per minutes per 1.732 (mL/min/1.73 m2), as measured by the central laboratory at screening
  • Chronic or intermittent haemodialysis or peritoneal dialysis

Locations

  • Lundquist Inst.-Biom Inno-UCLA accepting new patients
    Torrance California 90502 United States
  • Scripps Wht Diab Inst La Jolla accepting new patients
    La Jolla California 92037 United States
  • National Heart Institute Cal accepting new patients
    Beverly Hills California 90211 United States
  • Linda Vista Health Care Ctr accepting new patients
    San Diego California 92111 United States
  • Valley Clinical Trials, Inc. accepting new patients
    Northridge California 91325 United States
  • Pacific Clinical Studies accepting new patients
    Los Alamitos California 90720 United States
  • Torrance Clin Res Inst, Inc. accepting new patients
    Lomita California 90717 United States
  • Encompass Clinical Research_Spring Valley accepting new patients
    Spring Valley California 91978 United States
  • Western University of Health Sciences accepting new patients
    Pomona California 91766 United States
  • Western University of Health Sciences not yet accepting patients
    Pomona California 91766 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novo Nordisk A/S
ID
NCT05669755
Phase
Phase 3 Cardiovascular Disease Research Study
Study Type
Interventional
Participants
Expecting 7000 study participants
Last Updated