Prevention & lipidsRandomised controlled trial
Anti-Inflammatory Effects of Oral NLRP3 Inhibition With Ruvonoflast Among Individuals at Elevated Cardiovascular Risk
- Randomised controlled trial
- double-blind
- placebo-controlled
- Phase 1b
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
Primary result
As reported in the abstract
hsCRP reduction
- 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:10.1016/j.jacc.2026.05.014
Summarised from the published abstract; every number is checked against it