If you have coronary heart disease and a blood condition called clonal hematopoiesis of indeterminate potential (CHIP), your body may be stuck in a state of harmful, chronic inflammation. This inflammation, driven by proteins like IL-6 and IL-18, is thought to fuel further heart damage. A recent clinical trial asked a direct question: can we safely turn down that inflammatory fire? The study tested two experimental drugs—DFV890, taken as a daily pill for 12 weeks, and MAS825, given as a single injection—in approximately 28 adults who had both heart disease and specific types of CHIP. The goal was to see if these treatments could reduce levels of IL-6 and IL-18, which are key markers of cardiovascular risk. This was a carefully controlled study where participants were randomly assigned to receive one of the drugs or a placebo, and neither they nor their doctors knew which they got. The main outcomes measured were how much the drugs changed the levels of these inflammation markers from the start of the study. While the abstract doesn't give the final results, the core finding is that researchers have completed a direct test of whether targeting these specific inflammatory pathways is a viable approach for this high-risk group of patients. The answer to that question could reshape how we think about treating heart disease when it's intertwined with CHIP.
Can two experimental drugs calm the dangerous inflammation linked to heart disease and a blood condition called CHIP?
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What this means for you:
Two drugs were tested to lower heart-risk inflammation in people with both coronary disease and a blood condition called CHIP. What this means for you:
Two drugs were tested to lower heart-risk inflammation in people with both coronary disease and a blood condition called CHIP. View Original Abstract ↓
Status: COMPLETED | Phase: PHASE2
Condition(s): Coronary Heart Disease, Clonal Hematopoiesis of Indeterminate Potential (CHIP)
Intervention(s): MAS825 (DRUG), MAS825 Placebo (DRUG), DFV890 (DRUG), DFV890 placebo (DRUG)
This Phase 2a clinical trial evaluated the effectiveness, safety, and tolerability of increasing dose strengths of an oral daily medication, DFV890, administered for 12 weeks, or a single s.c. dose of MAS825, to reduce key markers of inflammation related to CVD risk, such as IL-6 and IL-18, in approximately 28 people with known coronary heart disease and TET2 or DNMT3A CHIP (variant allele frequency \[VAF\] ≥2%).
Detailed: This was a multi-center, randomized, placebo-controlled, participant- and investigator-blinded study.
The study consisted of a screening period up to 30 days; a treatment period of approximately 12 weeks with an end of treatment (EOT) visit on Day 85, which is one day after the last dose of DFV890 or placebo; a follow-up period of approximately 1 week; and a standard safety follow-up call approximately 30 days following the last dose. The overall study duration is approximately 21 weeks.
Participants were randomized to one of five treatment sequences. Based on the treatment sequence assignments, participants started on either a combination of MAS825 and placebo, DFV890 and placebo, or placebo and placebo on Day 1, and then, within each DFV890 treatment sequence, participants received up-
Primary Outcome(s): Ratio to Baseline Serum Levels of IL-6 for DFV890 Based on an Emax Model; Ratio to Baseline Serum Levels of IL-18 for DFV890 Based on an Emax Model; Ratio to Baseline Serum Levels of IL-6 for MAS825 Based on a Traditional Linear Regression Model
Enrollment: 31 (ACTUAL)
Lead Sponsor: Novartis Pharmaceuticals
Start: 2024-02-15 | Primary Completion: 2024-10-27
Results posted: 2026-03-27