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

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Kowa

Status and phase

Completed
Phase 2

Conditions

Dyslipidemia

Treatments

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

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)

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

Trial documents
4

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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