A Study to Investigate the Efficacy, Safety, and Tolerability of DFV890 for Inflammatory Marker Reduction in Adult Participants With Coronary Heart Disease and Elevated hsCRP

Summary

This Phase 2a clinical trial evaluated the effectiveness, safety, and tolerability of increasing dose strengths of an oral daily medication, DFV890, administered for 12 weeks, to reduce key markers of inflammation related to CVD risk, such as IL-6 and IL-18, in approximately 24 people with known heart disease and an elevated marker of inflammation, hsCRP.

Timeline

Start

2023-10-16

Primary completion

2024-12-17

Completion

2024-12-23

Outcome

Met primary endpoint

registry analysis (superiority test); DFV890 10 mg vs Placebo; p = 0.0011; Ratio of the Geometric Mean 0.6642 (80% CI 0.5688 to 0.7755); Emax model NCT06031844 ↗

registry analysis (superiority test); DFV890 10 mg vs Placebo; p = 0.0108; Ratio of the Geometric Mean 0.9375 (80% CI 0.9058 to 0.9703); Emax model NCT06031844 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	DFV890	Unknown	100 mg	Oral

Indications