pemafibrate ER (K-877-ER) / Kowa - LARVOL DELTA

Effects of Pemafibrate on Cholesterol Synthesis and Absorption: a Post-Hoc Subgroup Analysis of a Phase 2 Clinical Trial. (PubMed, J Atheroscler Thromb) - "In patients with hypertriglyceridemia, results suggested that pemafibrate lowered LDL-C by inhibiting cholesterol synthesis in the liver and cholesterol absorption from the intestinal tract. This lowering effect was greater in populations with higher baseline LDL-C."

Journal • P2 data • Retrospective data • Diabetes • Dyslipidemia • Hypertriglyceridemia • Metabolic Disorders • Type 2 Diabetes Mellitus • APOB

Long-Term Effects of Extended-Release Pemafibrate Tablets on Dyslipidemia and Safety in Triglyceridemic Patients: A Phase 3, Multicenter, Randomized, Open-Label, Parallel-Group Study. (PubMed, J Atheroscler Thromb) - "Long-term, once-daily administration of XR was effective and safe in dyslipidemic patients with high TG. XR provided favorable TG-lowering effects regardless of morning or evening administration, and the XR dose increase proved effective in patients having initially inadequate response."

Journal • P3 data • Dyslipidemia • Hypertriglyceridemia • Metabolic Disorders

Clinical Pharmacology of Pemafibrate Extended-release Formulation in Patients with Hypertriglyceridemia-A Phase 2, Multicenter, Active-controlled, Randomized, Single-blind, Crossover study. (PubMed, J Atheroscler Thromb) - "In patients with hypertriglyceridemia, XR substantially lowered TG at all doses, with maximum effectiveness at 0.4 mg/day, the dose approved in Japan, to a level comparable to IR 0.2 mg/day. There were no safety concerns up to 0.8 mg/day."

Journal • P2 data • Dyslipidemia • Hypertriglyceridemia • PPARA

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

Once-daily Extended-Release Pemafibrate Enhances Adherence and Triglyceride Control Over Twice-Daily Dosing. (PubMed, J Atheroscler Thromb) - No abstract available

Adherence • Journal

Efficacy and Safety of Pemafibrate Extended-Release Tablet: a Phase 3, Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel-Group Comparison Trial. (PubMed, J Atheroscler Thromb) - "XR (0.2 and 0.4 mg/day) was non-inferior to IR (0.2 mg/day). XR 0.4 mg/day demonstrated a more potent triglyceride-lowering effect than XR 0.2 mg/day and should be considered for patients with high triglyceride levels."

Clinical • Journal • P3 data • Dyslipidemia • Hypertriglyceridemia • Metabolic Disorders

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

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 | Not yet recruiting | Sponsor: Kowa Research Institute, Inc.

New P1 trial

Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis (clinicaltrials.gov) - P2 | N=400 | Recruiting | Sponsor: Kowa Research Institute, Inc. | Trial completion date: Sep 2024 ➔ May 2025 | Trial primary completion date: Jul 2024 ➔ Apr 2025

Combination therapy • Trial completion date • Trial primary completion date • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Non-alcoholic 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=400 | Recruiting | Sponsor: Kowa Research Institute, Inc. | Initiation date: Jun 2022 ➔ Sep 2022

Combination therapy • Trial initiation date • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Non-alcoholic Steatohepatitis

A Phase III Long Term Study of K-877 Extended Release Tablet (clinicaltrials.gov) - P3 | N=121 | Completed | Sponsor: Kowa Company, Ltd. | Active, not recruiting ➔ Completed | Trial primary completion date: Sep 2022 ➔ Jun 2022

Trial completion • Trial primary completion date • Dyslipidemia • Metabolic Disorders

Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis (clinicaltrials.gov) - P2 | N=400 | Recruiting | Sponsor: Kowa Research Institute, Inc.

Combination therapy • New P2 trial • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Non-alcoholic Steatohepatitis

A Phase III Confirmatory Study of K-877 Extended Release Tablet (clinicaltrials.gov) - P3; N=356; Completed; Sponsor: Kowa Company, Ltd.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Dyslipidemia • Metabolic Disorders

A Phase III Confirmatory Study of K-877 Extended Release Tablet (clinicaltrials.gov) - P3; N=345; Active, not recruiting; Sponsor: Kowa Company, Ltd.; Recruiting ➔ Active, not recruiting

Enrollment closed • Dyslipidemia • Metabolic Disorders

A Phase III Long Term Study of K-877 Extended Release Tablet (clinicaltrials.gov) - P3; N=110; Active, not recruiting; Sponsor: Kowa Company, Ltd.; Recruiting ➔ Active, not recruiting

Enrollment closed • Dyslipidemia • Metabolic Disorders

A Phase III Long Term Study of K-877 Extended Release Tablet (clinicaltrials.gov) - P3; N=110; Recruiting; Sponsor: Kowa Company, Ltd.; Not yet recruiting ➔ Recruiting

Enrollment open • Dyslipidemia • Metabolic Disorders

A Phase III Confirmatory Study of K-877 Extended Release Tablet (clinicaltrials.gov) - P3; N=345; Recruiting; Sponsor: Kowa Company, Ltd.; Not yet recruiting ➔ Recruiting

Enrollment open • Dyslipidemia • Metabolic Disorders

Study to Investigate the Efficacy and Pharmacokinetic Profile of K-877-ER Compared to K-877-IR (clinicaltrials.gov) - P2; N=96; Completed; Sponsor: Kowa Research Institute, Inc.; Recruiting ➔ Completed

Clinical • Trial completion • Dyslipidemia • Metabolic Disorders

A Phase III Long Term Study of K-877 Extended Release Tablet (clinicaltrials.gov) - P3; N=110; Not yet recruiting; Sponsor: Kowa Company, Ltd.

Clinical • New P3 trial • Dyslipidemia • Metabolic Disorders

A Phase III Confirmatory Study of K-877 Extended Release Tablet (clinicaltrials.gov) - P3; N=345; Not yet recruiting; Sponsor: Kowa Company, Ltd.

Clinical • New P3 trial • Dyslipidemia • Metabolic Disorders