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Rezera's ruvonoflast boosts semaglutide's anti-inflammatory effects in Phase II trial

Rezera's ruvonoflast boosts semaglutide's anti-inflammatory effects in Phase II trial

Boston, Massachusetts-based Rezera Inc. reported positive topline results from the Phase II RESOLVE-2 trial, showing that its oral NLRP3 inhibitor ruvonoflast produced statistically significant additional reductions in the inflammatory biomarker high-sensitivity C-reactive protein (hsCRP) when combined with semaglutide, compared with semaglutide alone, in adults with obesity. ​

The randomized, double-blind trial enrolled 82 participants who received ruvonoflast or placebo for 32 weeks alongside weekly semaglutide. Among those with baseline hsCRP of at least 2 mg/L, the combination more than doubled the likelihood of reducing hsCRP below that threshold. Weight loss was comparable between groups, while ruvonoflast was generally well tolerated, with no new safety signals. Safety and tolerability were the study's primary objectives, and detailed numerical efficacy and safety data were not disclosed.

The findings build on earlier results for ruvonoflast, including a Phase Ib study published in the Journal of the American College of Cardiology in May 2026, which showed an 82.2% reduction in hsCRP after 28 days of treatment, compared with 37.2% for placebo, in participants at elevated cardiovascular risk. Rezera, formerly known as NodThera, also reported in September that its Phase II RESOLVE-1 trial had met its primary inflammation endpoint.

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Rezera plans to initiate a Phase III trial of ruvonoflast in peripheral artery disease (PAD) in H1 2027, following alignment with regulators on the study design. The company is investigating whether targeting NLRP3-mediated inflammation can address residual cardiovascular risk, although the biomarker improvements observed to date have not established a reduction in cardiovascular events or other clinical outcomes.


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