Clinical safety and efficacy data
Lanifibranor was advanced through completion of Phase I clinical trials in which lanifibranor was administered to 125 healthy volunteers, and Phase IIa clinical trials in which lanifibranor was administered to 47 patients with type 2 diabetes over a period of four weeks. In these trials, lanifibranor was reported to be well tolerated and exhibited a favorable safety profile, including with respect to key markers of liver, kidney, heart, muscle and bone function.
In addition lanifibranor demonstrated the improvement of relevant biomarkers for insulin resistance and dyslipidemia, specifically it decreased in a dose dependent manner triglycerates, and increased HDL-cholesterol and adiponectin.
