Open Clinical Trials

Non-alcoholic Steatohepatitis (NASH)

Study title: ASCEND-NASH: A Phase 2B, Randomized, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of CRV431 in Adult Subjects with Nonalcoholic Steatohepatitis and Advanced Liver Fibrosis

Status: Enrolling

Clinicaltrials.gov Identifier: NCT05402371

Study title: ALTITUDE-NASH: A Phase 2, Randomized, Multi-Center, Open-Label Study to Evaluate the Safety and Efficacy of Rencofilstat in Adult Subjects with Non-Alcoholic Steatohepatitis Stage 3 Fibrosis

Status: Enrolling

Clinicaltrials.gov Identifier: NCT05461105

Hepatocellular Carcinoma (HCC)

Study title: ASPIRE-HCC: A Phase 2a, Open-Label, Multi-Center, Simon 2‑Stage Clinical Study to Assess the Preliminary Efficacy, Safety, and Pharmacokinetics of CRV431 in Advanced Metastatic Resistant or Refractory Hepatocellular Carcinoma Subjects

Status: Upcoming

Clinicaltrials.gov Identifier: TBD

Phase 2 (Completed)

Study title: AMBITION-NASH: A Phase 2, Randomized, Multi-Center, Open-Label Study to Evaluate the Safety and Efficacy of Rencofilstat in Adult Subjects with Non-Alcoholic Steatohepatitis Stage 3 Fibrosis

Clinicaltrials.gov Identifier: NCT04480710

Results: Rencofilstat was safe and well tolerated in this patient population. Efficacy signals were seen at 28 days of dosing: reductions in liver enzyme ALT (marker of inflammation) and PRO-C3 (marker of fibrosis). Rencofilstat exposure is similar in subjects with NASH compared to healthy subjects.

For more details on study results, please view our two conference posters and publication:

The Liver Meeting 2021, AASLD
Investigating CRV431 in NASH Patients: Data From the Phase 2a AMBITION Study

NASH-TAG Conference 2022
Rencofilstat (CRV431) in NASH Patients: The Phase 2a AMBITION Study

Rencofilstat, a cyclophilin inhibitor: A phase 2a, multicenter, single-blind, placebo-controlled study in F2/F3 NASH

Phase 1 (Completed)

Study title: A Randomized, Partially-blinded, Placebo-controlled, Ascending Sequential Dose Groups, Single Dose Study of the Safety, Tolerability and Pharmacokinetics of CRV431, Alone and In Combination With Tenofovir Disoproxil Fumarate in Healthy Subjects, With a Pilot Study of Multiple Ascending Sequential Doses in HBV-Infected Subjects on Chronic Tenofovir Disoproxil Fumarate Treatment

Results: Rencofilstat is safe and well tolerated as a single dose up to 525 mg and multiple ascending dose up to 375 mg for 28 days. Favorable pharmacokinetic and safety data allow rencofilstat to continue onto phase 2.

Clinicaltrials.gov Identifier: NCT03596697

Study title: A Single Center, Open-Label, Phase 1 Drug-Drug Interaction Study to Evaluate the Pharmacokinetics of CRV431 in Normal Healthy Volunteer Subjects

Status: Completed

Study title: A Single Center, Open-Label, Phase 1 Study to Evaluate the Pharmacokinetics of CRV431 Under Fasted and Fed States in Normal Healthy Volunteer Subjects

For details on study results, please see our publication:

Effect of a High‐Fat Meal on Single‐Dose Rencofilstat (CRV431) Oral Bioavailability in Healthy Human Subjects