Anti-Inflammatory Effects of Oral NLRP3 Inhibition With Ruvonoflast Among Individuals at Elevated Cardiovascular Risk
Authors' conclusion
Oral NLRP3 inhibition with ruvonoflast significantly reduced hsCRP with concurrent reductions in inflammatory biomarkers in participants with elevated inflammatory risk.
Study context
- Population
- Individuals with high-sensitivity C-reactive protein (hsCRP) ≥2.5 mg/L and BMI ≥30 to ≤40 kg/m², plus dyslipidemia, hypertension or T2DM, on a 2,000 kcal/d diet59 completed
- Participants
- 63 individuals
- Comparison
- Oral ruvonoflast vs placebo
- Ruvonoflastn = 40
- Placebon = 23reference
- Primary endpoint
- Change in hsCRP (ratio to baseline)
- Follow-up
- Day 28
Methodological detailsdouble-blind, placebo-controlled, Phase 1b
- Double-blind
- Placebo-controlled
- Phase 1b
Primary result
As reported in the abstract
hsCRP reduction
Ruvonoflast
82.2%
geometric least-squares mean reduction · 95% CI 75.9%–86.8%
Placebo
37.2%
geometric least-squares mean reduction · 95% CI 7.0%–57.6%
- Posterior probability of superiority of ruvonoflast over placebo (Bayesian ANCOVA)
- >99%
Secondary outcomes
hsCRP over time · from Day 3 onward
- Between-group differences favouring ruvonoflast significant
- P ≤ 0.001
- hsCRP returned to baseline 7 days after treatment discontinuation
Interleukin-6 and fibrinogen · Day 28
- Significantly lowered with ruvonoflast vs placebo
- P < 0.001
Body weight · Day 28
- Comparable mean percentage body weight reductions between groups
Safety
| Outcome | Ruvonoflast | Placebo |
|---|---|---|
| Discontinuation due to transient, reversible treatment-emergent adverse events | 10% | 0 events |
Discontinuation due to transient, reversible treatment-emergent adverse events
- Serious treatment-emergent adverse events similar between groups
Original publication
Anti-Inflammatory Effects of Oral NLRP3 Inhibition With Ruvonoflast Among Individuals at Elevated Cardiovascular Risk. J Am Coll Cardiol. Published 26 May 2026. doi:10.
Summarised from the published abstract; every number is checked against it