pemafibrate/tofogliflozin (K-001) / Kowa - LARVOL DELTA

Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis (clinicaltrials.gov) - P2 | N=228 | Active, not recruiting | Sponsor: Kowa Research Institute, Inc. | Trial completion date: Mar 2026 ➔ Jun 2026 | Trial primary completion date: Feb 2026 ➔ May 2026

Trial completion date • Trial primary completion date • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Metabolic Dysfunction-Associated Steatohepatitis

Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis (clinicaltrials.gov) - P2 | N=228 | Active, not recruiting | Sponsor: Kowa Research Institute, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Metabolic Dysfunction-Associated Steatohepatitis

Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Kowa Research Institute, Inc. | N=300 ➔ 200 | Trial completion date: Jun 2025 ➔ Mar 2026 | Trial primary completion date: May 2025 ➔ Feb 2026

Combination therapy • Enrollment change • Trial completion date • Trial primary completion date • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Metabolic Dysfunction-Associated Steatohepatitis

Study to Demonstrate the Bioequivalence of Single Oral Administration of K-001 Relative to Single Oral Coadministration of Separate Tablets of K-877-ER and CSG452 (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Kowa Research Institute, Inc. | Recruiting ➔ Completed

Trial completion

Study to Demonstrate the Bioequivalence of Single Oral Administration of K-001 Relative to Single Oral Coadministration of Separate Tablets of K-877-ER and CSG452 (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Kowa Research Institute, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open