Effects of NT-0796 in Obese Participants at Risk of Cardiovascular Disease

Summary

This trial is a Randomized, Double-Blind (Sponsor-Open), Placebo-Controlled Study to Assess the Effect of NT-0796 on Inflammation in Obese Participants at Risk of Cardiovascular Disease. Participants will be admitted to an in-patient Clinical Research Unit on Day -1 and will be discharged on Day 30. The trial will include a 7-day out-patient safety follow-up period following the last dose of study treatment. For the first approximately 20 participants effect of food will be evaluated on the Pharmacokinetics of NT-0796. MRI's will be conducted in a subset of participants.

Timeline

Start

2023-10-10

Primary completion

2024-04-15

Completion

2024-04-15

Outcome

Met primary endpoint

paper The primary endpoint of hsCRP reduction was met with a posterior probability of >99% for superiority of ruvonoflast over placebo at Day 28. PMID 42187339 ↗

Publications

• Ray KK, Clarke N, Thornton P, Miles AE, Digby Z, Davies MJ, Gorman M, Mullen B, Reader V, Magill M, Johnstone H, Ariti C, Sattar N, Marx N, Navar AM, Hernandez AF, George JT, Watt AP, Butler J, Ridker PM. Anti-Inflammatory Effects of Oral NLRP3 Inhibition With Ruvonoflast Among Individuals at Elevated Cardiovascular Risk. J Am Coll Cardiol. 2026 May 26:S0735-1097(26)06570-8. doi: 10.1016/j.jacc.2026.05.014. Online ahead of print.

Drugs

Indications