Evaluating the safety and effectiveness of RBD4059 for stable coronary artery disease

A Randomized, Double-blind, Placebo-controlled Phase IIa Trial to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of Repeated Subcutaneously Administered RBD4059 in Participants with Stable Coronary Artery Disease

This study is testing a new drug called RBD4059 to see if it is safe and effective for adults with stable coronary artery disease compared to a placebo.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 50 Years to 75 Years
• Sex: All
• Sponsor: Ribocure Pharmaceuticals AB (industry)
• Locations: 1 site (Mölndal)
• Trial ID: NCT06717074 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety, pharmacokinetics, and pharmacodynamics of the drug RBD4059 in adults with stable coronary artery disease (CAD). Participants will be randomly assigned to receive either RBD4059 or a placebo, with a total of 11 to 12 clinic visits over a period of 11 to 14 months for monitoring and testing. The trial will begin with a low-dose group, and if safety is confirmed, a high-dose group will follow. The study will focus on identifying any medical issues participants may experience while taking the drug and evaluating its effectiveness compared to a placebo.

Who should consider this trial

Good fit: Ideal candidates are males and post-menopausal females aged 50-75 with stable coronary artery disease who have been on standard treatment with aspirin.

Not a fit: Patients with significant arrhythmias or those experiencing acute coronary syndrome or unstable angina may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could provide a new treatment option for patients with stable coronary artery disease.

How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in evaluating new treatments for coronary artery disease.

Eligibility criteria

Inclusion Criteria:

* Willing and able to give written informed consent for participation in the trial.
* Male or female (post-menopausal) participants ≥50-75 years.
* Patients with stable CAD defined as chronic coronary syndromes according to ESCs guideline on chronic coronary syndromes including the category asymptomatic or symptomatic patients more than 1 year after initial diagnosis or revascularization.
* Ongoing standard treatment with aspirin 75 mg for at least 3 months
* Stable prescription drugs i.e., ongoing since at least 30 days prior to randomization, should continue during the trial.

Main exclusion Criteria:

* Presence of any significant arrythmia in opinion of the investigator
* Any clinical suspicion on acute coronary syndrome or unstable angina at enrolment according to ESC criteria : (i) rest angina, i.e. pain of characteristic nature and location occurring at rest and for prolonged periods (more than 20 min); (ii) new-onset angina, i.e. recent (2 months) onset of moderate-to-severe angina (Canadian Cardiovascular Society grade II or III); or (iii) crescendo angina, i.e. previous angina, which progressively increases in severity and intensity, and at a lower threshold, over a short period of time.
* Patients with other clinical scenarios qualifying in the ESC definition of chronic coronary syndromes: patients with suspected CAD and 'stable' anginal symptoms, and/or dyspnoea, with new onset of heart failure (HF) or left ventricular (LV) dysfunction and suspected CAD, with angina and suspected vasospastic or microvascular disease.
* High bleeding risk defined as history of any significant bleeding (included but not limited to intracerebral haemorrhage and gastrointestinal), anaemia, liver failure, age more than 75 years or Clinical Frailty Score more than 5, or weight less than 60kg.
* Major surgery during last 30 days or planned major surgery or intervention within trial period.
* Capillary Hb less than 120 g/l for women and less than 130 g/L for men.
* Elective PCIor CABG within the previous 12 months.
* Previously confirmed ischemic stroke.
* Ongoing indication for chronic anti-coagulation therapy (incl. but not limited to patients with: atrial fibrillation, venous thrombo-embolism, mechanical cardiac valves) with NOACs, warfarin or other similar anticoagulants.
* Left ventricular ejection fraction (LVEF) less than 30% at enrolment.
* New York Heart Association (NYHA) class III-IV heart failure at entry, hospitalization for exacerbation of chronic heart failure within the previous 12 months or other indices of unstable heart failure.
* Creatinine clearance calculated by Cockcroft Gault equation less than 60ml/min\*m2 at the time of enrolment. Hemodynamically significant valvular disease or valvular disease likely to require surgery within 3 years.
* Hemodynamically significant valvular disease or valvular disease likely to require surgery within 3 years.
* Expected survival time is less than one year for non-cardiac related disorders.
* History or presence of:

  1. Bleeding disorder(s) and/or at risk of bleeding, including relevant familial history.
  2. Thromboembolic diseases.

Where this trial is running

Mölndal

• Ribocure Clinic — Mölndal, Sweden (RECRUITING)

Study contacts

• Study coordinator: Rebeckha Magnusson Head of Clin Ops and QA

Conditions: Stable Coronary Artery Disease CAD