Study to Investigate the Efficacy and Pharmacokinetic Profile of K-877-ER Compared to K-877-IR

Kowa

Status and phase: Completed; Phase 2

Conditions: Dyslipidemia

Treatments: Drug: K-877-ER (Dose A); Drug: K-877-IR; Drug: K-877-ER (Dose B)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04447820

K-877-ER-201

Details and patient eligibility

About

A study to evaluate the efficacy of K-877 extended release (ER) once daily (QD) compared to K-877 immediate release (IR) twice daily (BID).

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to provide written informed consent before any study-specific evaluation is performed
• At screening, have a mean fasting TG level of ≥180 mg/dL and <550 mg/dL; at subsequent Qualification Period visits confirm fasting TG level of ≥200 mg/dL and <500 mg/dL
• Able to meet all inclusion criteria outlined in clinical study protocol

Exclusion criteria

• Require lipid-altering treatments other than study drugs, statins, ezetimibe, or PCSK9 inhibitors during the study
• Known hypersensitivity or intolerance to fibrates or peroxisome proliferator-activated receptor alpha agonists
• Meet any other exclusion criteria outlined in clinical study protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 3 patient groups

K-877-ER Dose A

Experimental group

Description:

K-877-ER dose A administered once daily

Treatment:

Drug: K-877-ER (Dose A)

K-877-ER Dose B

Experimental group

Description:

K-877-ER dose B administered once daily

Treatment:

Drug: K-877-ER (Dose B)

K-877-IR

Experimental group

Description:

K-877-IR administered twice daily.

Treatment:

Drug: K-877-IR