NCT07884136

RBD1119 in Coronary Artery Disease (CAD)

StatusNot Yet Recruiting

PhasePhase 2

SponsorRibocure Pharmaceuticals AB

Primary completionSep 30, 2027 (estimated)

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Record History

All 1 version: 1 with changes below.

Oct 13, 2026 Study First Submitted

Endpoints

Primary

Primary objective

Timeframe: Week 8

Primary endpoint

Timeframe: Week 8

Secondary (1)

Secondary objective

Arms and interventions

Low-dose groupExperimental

Medium-dose groupExperimental

High-dose groupExperimental

Drugs: RBD1119, Placebo

Sites

16 sites in 2 countries

Poland 11, Sweden 5

About this trial

CAD is driven by atherosclerosis in the coronary arteries and is a major cause of myocardial infarction, heart failure, arrhythmias, and premature death. Despite contemporary secondary prevention including lipid lowering, revascularization when indicated, and antiplatelet therapy, participants with established CAD, particularly those post-ACS, remain at clinically meaningful residual risk of recurrent atherothrombotic events. Intensifying antithrombotic therapy can reduce ischemic events but typically increases bleeding, as exemplified by the addition of low dose rivaroxaban to aspirin in stable atherosclerotic disease. This persistent efficacy-safety trade-off supports development of antithrombotic approaches that reduce pathological thrombosis while preserving hemostasis. RBD1119 is a GalNAc-conjugated siRNA that targets factor XI mRNA in hepatocytes. The GalNAc moiety binds the asialoglycoprotein receptor on hepatocyte surfaces, enabling receptor mediated endocytosis and preferential hepatic uptake. Once internalized, RBD1119 mediates cleavage of factor XI mRNA via the RNA interference pathway, reducing hepatic factor XI expression and lowering circulating factor XI levels. This multicenter, randomized, double-blind, placebo-controlled, phase II trial will evaluate the PD, safety, and PK of subcutaneously administered RBD1119 in participants with stable coronary artery disease (CAD).

Trial details

Enrollment: 200 participants (estimated)
Started: Oct 16, 2026
Study completion: Mar 18, 2028 (estimated)
Eligibility: 50 and older, all sexes, no healthy volunteers
Design: Interventional, randomized, quadruple blind, treatment
Oversight: Data monitoring committee
Conditions: Stable Coronary Artery Disease
Collaborators: Fortrea
Official title: A Randomized, Double-blind, Placebo-controlled Phase II Trial to Evaluate Safety, and Pharmacodynamics of Repeated Subcutaneously Administered RBD1119 in Participants With CAD
First posted: Oct 20, 2026
Registry updated: Oct 20, 2026
Last verified: Oct 2026

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