Pemafibrate

Generic Name: Pemafibrate

Drug Type: Small Molecule

Chemical Formula: C_₂₈H_₃₀N_₂O_₆

CAS Number: 848259-27-8

Unique Ingredient Identifier: 17VGG92R23

Background: Pemafibrate is under investigation in clinical trial NCT03350165 (A Study of Pemafibrate in Patients With Nonalcoholic Fatty Liver Disease (NAFLD)).

Clinical Trials

Efficacy and Safety of Pemafibrate for Nonalcoholic Fatty Liver Disease

Phase 2

Active, not recruiting

Conditions: Non Alcoholic Fatty Liver Disease

Interventions: Drug: Pemafibrate low dose
Drug: Fenofibrate
Drug: Pemafibrate high dose

First Posted Date: 2024-10-02

Last Posted Date: 2024-10-02

Lead Sponsor: Yokohama City University

Target Recruit Count: 360

Registration Number: NCT06623539

Locations: 🇯🇵
Yokohama city university, Yokohama, Kanagawa, Japan

A Study to Evaluate the Pharmacokinetics and Safety of K-808 (Pemafibrate) in Subjects With Primary Biliary Cholangitis With Compensated Cirrhosis and Without Cirrhosis.

Phase 1

Completed

Conditions: Primary Biliary Cholangitis
Compensated Cirrhosis

Interventions: Drug: K-808

First Posted Date: 2024-07-29

Last Posted Date: 2025-05-09

Lead Sponsor: Kowa Research Institute, Inc.

Target Recruit Count: 17

Registration Number: NCT06525311

Locations: 🇯🇵
301, Yufu, Japan
🇺🇸
Arizona Liver Health, Chandler, Arizona, United States
🇺🇸
Southern California Research Center, Inc, Coronado, California, United States

and more 11 locations

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

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: K-001
Drug: K-877-ER
Drug: CSG452

First Posted Date: 2023-02-10

Last Posted Date: 2023-06-02

Lead Sponsor: Kowa Research Institute, Inc.

Target Recruit Count: 30

Registration Number: NCT05722262

Locations: 🇺🇸
PPD - Austin Research Unit, Austin, Texas, United States

Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis

Phase 2

Recruiting

Conditions: NASH

Interventions: Drug: K-877-ER
Drug: CSG452
Drug: Placebo

First Posted Date: 2022-04-14

Last Posted Date: 2025-05-15

Lead Sponsor: Kowa Research Institute, Inc.

Target Recruit Count: 200

Registration Number: NCT05327127

Locations: 🇺🇸
Centricity Research, Columbus, Georgia, United States
🇺🇸
Birmingham Digestive Health Research, Inc., Birmingham, Alabama, United States
🇺🇸
Adobe Clinical Research, LLC, Tucson, Arizona, United States

and more 98 locations

Study to Assess the Food Effect of K-877 in Healthy Adult Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: K-877

First Posted Date: 2021-02-08

Last Posted Date: 2021-08-09

Lead Sponsor: Kowa Research Institute, Inc.

Target Recruit Count: 18

Registration Number: NCT04742218

Locations: 🇺🇸
PPD Development, LP, Austin, Texas, United States

Pharmacokinetic Drug-Drug Interaction Study Between K-877 and CSG452 in Healthy Adult Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: K-877
Drug: CSG452

First Posted Date: 2020-01-23

Last Posted Date: 2020-09-22

Lead Sponsor: Kowa Research Institute, Inc.

Target Recruit Count: 20

Registration Number: NCT04237597

Locations: 🇺🇸
PPD Development. LP, Austin, Texas, United States

A Study of Pemafibrate in Patients With Nonalcoholic Fatty Liver Disease (NAFLD)

Phase 2

Completed

Conditions: Non-Alcoholic Fatty Liver Disease

Interventions: Drug: Placebo
Drug: K-877

First Posted Date: 2017-11-22

Last Posted Date: 2021-04-09

Lead Sponsor: Kowa Company, Ltd.

Target Recruit Count: 118

Registration Number: NCT03350165

Locations: 🇯🇵
Fukuwa Clinic, Chuo-ku, Tokyo, Japan
🇯🇵
Fukuoka University Hospital, Fukuoka, Fukuoka, Japan
🇯🇵
Niigata University Medical & Dental Hospital, Niigata, Niigata, Japan

and more 13 locations

PROMINENT-Eye Ancillary Study (Protocol AD)

Phase 3

Terminated

Conditions: Diabetic Retinopathy
Diabetic Macular Edema

Interventions: Drug: Placebo
Drug: Pemafibrate

First Posted Date: 2017-11-17

Last Posted Date: 2020-09-16

Lead Sponsor: Jaeb Center for Health Research

Target Recruit Count: 18

Registration Number: NCT03345901

Locations: 🇺🇸
Wilmer Eye Institute at Johns Hopkins, Baltimore, Maryland, United States
🇺🇸
University of Florida College of Med., Department of Ophthalmology, Jacksonville Health Science Cent, Jacksonville, Florida, United States
🇺🇸
Valley Eye Physicians and Surgeons, Ayer, Massachusetts, United States

and more 59 locations

Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT)

Phase 3

Terminated

Conditions: Type2 Diabetes
Dyslipidemia

Interventions: Drug: Placebo
Drug: K-877

First Posted Date: 2017-03-07

Last Posted Date: 2023-07-13

Lead Sponsor: Kowa Research Institute, Inc.

Target Recruit Count: 10544

Registration Number: NCT03071692

Locations: 🇺🇸
Alta Pharmaceutical Research Center, Inc., Dunwoody, Georgia, United States
🇨🇦
Discovery Clinical Services Ltd., Victoria, British Columbia, Canada
🇮🇳
Shree Multispecialty Hospital, Pune, Maharashtra, India

and more 860 locations

Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Mild or Moderate Renal Impairment

Phase 3

Completed

Conditions: Severe Hypertriglyceridemia

Interventions: Drug: K-877
Drug: Placebo (for K-877)
Drug: Fenofibrate

First Posted Date: 2017-01-05

Last Posted Date: 2022-10-28

Lead Sponsor: Kowa Research Institute, Inc.

Target Recruit Count: 471

Registration Number: NCT03011450

Locations: 🇺🇸
South Florida Research Solutions LLC., Pembroke Pines, Florida, United States
🇺🇸
Boyett Health Services Inc, Hamilton, Alabama, United States
🇺🇸
Longwood Research - Saadat Ansari, MD, LLC, Huntsville, Alabama, United States

and more 233 locations

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