Rezera Announces Positive RESOLVE-2 Phase 2 Clinical Trial Results Demonstrating Favorable Safety and Tolerability Profile for Ruvonoflast in Combination with Semaglutide
Combination of ruvonoflast and semaglutide produced greater reductions in hsCRP versus semaglutide monotherapy BOSTON,
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Combination of ruvonoflast and semaglutide produced greater reductions in hsCRP versus semaglutide monotherapy
BOSTON, Oct. 07, 2026 (GLOBE NEWSWIRE) — Rezera Inc. (the “Company”), a clinical-stage biotechnology company developing a portfolio of internally invented and wholly owned oral inhibitors of NLRP3 to address inflammatory drivers of cardiovascular and neurologic diseases, today announced positive topline results from RESOLVE-2, its Phase 2 clinical trial evaluating ruvonoflast in combination with semaglutide.
Ruvonoflast was generally well-tolerated when administered in combination with semaglutide, with a safety profile consistent with prior ruvonoflast clinical trial experience and with the known safety profile of semaglutide. There were no new safety signals, nor were there imbalances in safety parameters.
Participants receiving ruvonoflast in combination with semaglutide demonstrated additional, statistically significant reductions in inflammatory marker high-sensitivity C-reactive protein (hsCRP) compared with semaglutide alone, with separation between the ruvonoflast plus semaglutide group and the semaglutide monotherapy group maintained throughout the trial. Among participants with baseline hsCRP ≥2 mg/L, a threshold for elevated residual inflammatory risk in cardiovascular disease, ruvonoflast plus semaglutide more than doubled the likelihood of achieving hsCRP <2 mg/L versus semaglutide alone. Weight loss was comparable between the study arms in the overall population.
“These results demonstrate that ruvonoflast was able to deliver significant additive reductions in inflammatory markers when combined with semaglutide, without observed impacts on patient safety,” said Jyothis George, MBBS, Ph.D., Chief Medical Officer of Rezera. “Building on our positive monotherapy data in RESOLVE-1, RESOLVE-2 adds to our confidence in the approach of our previously announced Phase 3 trial in peripheral artery disease (PAD).”
“In the STRIDE trial, semaglutide increased walking distance to an extent that was clinically meaningful with similar improvements in symptoms and quality of life in patients with symptomatic PAD and diabetes mellitus, effects that have been hypothesized to be mediated largely through semaglutide’s anti-inflammatory activity,” said Marc Bonaca, M.D., M.P.H., Executive Director of the Colorado Prevention Center (CPC), Professor of Medicine and Director of Vascular Research at the University of Colorado Anschutz. “As Rezera plans a Phase 3 trial of ruvonoflast in PAD, it is encouraging to see significant additive reductions in multiple inflammatory markers when ruvonoflast was combined with semaglutide. These findings support the potential for NLRP3 inhibition to address residual inflammatory risk in patients with PAD.”
RESOLVE-2 findings are consistent with previously published data in which ruvonoflast demonstrated an 82% reduction in hsCRP and concordant reductions in multiple thrombo-inflammatory markers, including IL-6, IL-18 and fibrinogen. Together, these data support the potential of ruvonoflast to address residual inflammatory risk across cardiometabolic and cardiovascular populations, including PAD.
The Company plans to present findings from RESOLVE-2 at an upcoming medical conference and submit them for publication in a peer-reviewed medical journal. Rezera is also presenting data from the RESOLVE-1 Phase 2 trial evaluating ruvonoflast in participants with elevated cardiometabolic risk in a late-breaking Featured Science presentation at the American Heart Association (AHA) Scientific Sessions, taking place November 6-9, 2026, in Chicago, Illinois.
About RESOLVE-2
The RESOLVE-2 Phase 2 clinical trial was a randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the safety, tolerability and exploratory effects of ruvonoflast as an adjunct to semaglutide, in adults with obesity (NCT07220629). Eligible participants were randomized 1:1 to receive either oral ruvonoflast or matching placebo for 32 weeks, with all participants receiving once-weekly subcutaneous semaglutide titrated according to the approved U.S. prescribing information up to 2.4 mg. The study enrolled 82 participants with safety and tolerability as the primary objective. Baseline hsCRP was not an inclusion criterion.
About Rezera
Rezera is a clinical-stage biotechnology company developing a portfolio of internally invented and wholly owned oral inhibitors of NLRP3 to address inflammatory drivers of cardiovascular and neurologic diseases driven by the NLRP3 inflammation pathway. The Company’s lead program, ruvonoflast (f/k/a NT-0796), is being developed for cardiovascular diseases and recently announced initiation of REVEAL-PAD study investigating the role of inflammation in patients with PAD.
Rezera is headquartered in Boston, Massachusetts, with an R&D base in Cambridge, UK.
Learn more at http://www.rezera.com/ or follow the Company on LinkedIn.
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