Chronic kidney diseases

At ENYO Pharma, patients with impaired kidney function are in the center of our discussions.

We are committed every day to develop new therapeutics for improving the quality of life of patients with chronic kidney diseases. Working closely with our patient advocacy partners, as key players as representatives of patients, families and caregivers, support our best strategy for clinical study development in CKD.

Phase 2 clinical trial in CKD and suspected MASH

What is the purpose of the clinical study?

Establish the effect of Vonafexor on kidney function in subjects with CKD and suspected MASH

Objectives: This clinical study is designed to establish the effect of 2 doses of Vonafexor on the kidney. This will be investigated in subjects with mild or moderate reduced estimated glomerular filtration rate (eGFR) and suspected metabolic dysfunction-associated steatohepatitis (MASH). In addition, the non-invasive multiparametric magnetic resonance imaging assessment of functional and structural changes in the kidney and in the liver will be investigated.
Design: The study is a phase 2, open-label, two-dose, randomized, parallel arms, single center study where subjects are participating for up to 32 weeks: 4 weeks of screening + 16 weeks of treatment + 12 weeks of follow-up.
Treatment: Participants will receive a low dose or a high dose of Vonafexor as oral tablet once daily for 16 weeks then stop the treatment for 12 weeks in the follow-up period.
Enrollment: The study aims at enrolling 60 patients in Germany.

What is Vonafexor?

The investigational drug for CKD and suspected MASH clinical study

Drug: Vonafexor is a small molecule with strong fibrolytic and anti-inflammatory properties in both organs, kidney and liver. Learn more about Vonafexor

Can I participate in the study?

I may be eligible if:

Age: I am 18–75 years, both inclusive
Sex: I am a woman or a man
Condition: I am overweight or obese with or without type 2 diabetes mellitus
Kidney function: I have a mild to moderate loss of kidney function
Liver: I have a presumed mild to higher liver fibrosis

Study status and site locations

The study is currently conducted in Germany.

Study status: Recruiting
Site locations: The study is currently conducted in Germany.

Learn more about the study

If you have any questions about the clinical study, please speak with your physician.
Please visit https://clinicaltrials.gov with the trial ID NCT06939816 or https://clinicaltrials.eu with the trial ID 2023-509192-16-00