DyslipidemiaPhase 2NCT04447820

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

A Phase 2 study testing K-877-ER (Dose A), K-877-ER (Dose B) and K-877-IR in people with Dyslipidemia, run by Kowa Research Institute, Inc. at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dyslipidemia
What is being tested?: K-877-ER (Dose A), K-877-ER (Dose B) and K-877-IR
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 96 participants
Where: 12 sitesUnited States
Study dates: 10 Jun 2020to 3 Dec 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

Pinnacle Research Group
Anniston, Alabama, 36207
Medpace Clinical Pharmacology, LLC
Cincinnati, Ohio, 45227
Columbus Regional Health
Columbus, Georgia, 31904
Aventiv Research, Inc.
Columbus, Ohio, 43213
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Manassas Clinical Research Center
Manassas, Virginia, 20110
Diabetes and Endocrinology Consultants, P.C.
Morehead City, North Carolina, 28557
Summit Research Group, LLC
Munroe Falls, Ohio, 44262
Progressive Medical Research
Port Orange, Florida, 32127
Health Concepts
Rapid City, South Dakota, 57702
Prism Research
Saint Paul, Minnesota, 55114
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Open-Label, 4-Week Study to Investigate the Efficacy and Pharmacokinetic Profile of K-877-ER Once Daily Treatment Compared to K-877-IR Twice Daily Treatment in Adult Patients With Fasting Triglyceride Levels

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).

Conditions: Dyslipidemia
Being tested: K-877-ER (Dose A), K-877-ER (Dose B), K-877-IR
Medical subject headings: Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

K-877-ER (Dose A)Drug
Dose A Oral Administration
K-877-ER (Dose B)Drug
Dose B Oral Administration
K-877-IRDrug
K-877-IR Oral Administration

Study groups in NCT04447820
Study group	Role	What they receive
K-877-ER Dose A	Experimental	K-877-ER dose A administered once daily Receives: Drug: K-877-ER (Dose A)
K-877-ER Dose B	Experimental	K-877-ER dose B administered once daily Receives: Drug: K-877-ER (Dose B)
K-877-IR	Experimental	K-877-IR administered twice daily. Receives: Drug: K-877-IR

What is being measured

The primary outcome is the main question the study is designed to answer.

Estimated Percentage Change in Fasting Triglyceride(s) (TG)
Measured: Baseline to Day 28

Secondary outcomes (8)

Percentage Change From Baseline to Day 28 in Total Cholesterol (TC)
Measured: Baseline to Day 28
Percentage Change From Baseline to Day 28 in Low-density Lipoprotein Cholesterol (LDL-C)
Measured: Baseline to Day 28
Percentage Change From Baseline to Day 28 in High-density Lipoprotein Cholesterol (HDL-C)
Measured: Baseline to Day 28
Percentage Change From Baseline to Day 28 in Remnant Cholesterol
Measured: Baseline to Day 28
Percentage Change From Baseline to Day 28 in Non-HDL-C
Measured: Baseline to Day 28
Percentage Change From Baseline to Day 28 in Free Fatty Acid (FFAs)
Measured: Baseline to Day 28
K-877 PK Parameters Cmax
Observed maximum measured plasma concentration (Cmax)
Measured: Day 28
K-877 PK Parameters AUC (Tau)
Measured: Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jun 20203 Dec 2020

First posted25 Jun 2020
Study start10 Jun 2020
Primary completion3 Dec 2020
Study completion3 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DyslipidemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04447820
Sponsor's protocol ID: K-877-ER-201
Status last verified: Nov 2023
First submitted: 19 Jun 2020
Last updated: 22 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dyslipidemia trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Open-Label, 4-Week Study to Investigate the Efficacy and Pharmacokinetic Profile of K-877-ER Once Daily Treatment Compared to K-877-IR Twice Daily Treatment in Adult Patients With Fasting Triglyceride Levels
ClinicalTrials.gov ID: NCT04447820
Acronym / sponsor ID: K-877-ER-201
Conditions: Dyslipidemia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: Kowa Research Institute, Inc.Industry (pharma, biotech, devices)
Study start: 10 Jun 2020 (actual)
Primary completion: 3 Dec 2020 (actual)
Study completion: 3 Dec 2020 (actual)
First posted: 25 Jun 2020 (actual)
Results: Posted 22 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
K-877-ER Dose A	Experimental	Drug: K-877-ER (Dose A)K-877-ER dose A administered once daily
K-877-ER Dose B	Experimental	Drug: K-877-ER (Dose B)K-877-ER dose B administered once daily
K-877-IR	Experimental	Drug: K-877-IRK-877-IR administered twice daily.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
K-877-ER (Dose A)Dose A Oral Administration	Drug	K-877-ER Dose A
K-877-ER (Dose B)Dose B Oral Administration	Drug	K-877-ER Dose B
K-877-IRK-877-IR Oral Administration	Drug	K-877-IR

Primary outcome

Estimated Percentage Change in Fasting Triglyceride(s) (TG)
Time frame: Baseline to Day 28

8 secondary outcomes

Percentage Change From Baseline to Day 28 in Total Cholesterol (TC)
Time frame: Baseline to Day 28
Percentage Change From Baseline to Day 28 in Low-density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline to Day 28
Percentage Change From Baseline to Day 28 in High-density Lipoprotein Cholesterol (HDL-C)
Time frame: Baseline to Day 28
Percentage Change From Baseline to Day 28 in Remnant Cholesterol
Time frame: Baseline to Day 28
Percentage Change From Baseline to Day 28 in Non-HDL-C
Time frame: Baseline to Day 28
Percentage Change From Baseline to Day 28 in Free Fatty Acid (FFAs)
Time frame: Baseline to Day 28
K-877 PK Parameters Cmax
Time frame: Day 28
K-877 PK Parameters AUC (Tau)
Time frame: Day 28

Results and safety

Results posted to the registry on 22 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
K-877-IR	32	31
K-877-ER Dose A	32	31
K-877-ER Dose B	32	29

Primary outcome: Estimated Percentage Change in Fasting Triglyceride(s) (TG)

Time frame: Baseline to Day 28. Least squares mean (Standard Deviation). Unit: Percent Change

Measure	K-877-IR n = 31	K-877-ER Dose A n = 30	K-877-ER Dose B n = 27
Value	-41.57 (3.295)	-36.79 (3.319)	-38.94 (3.553)

K-877-IR vs K-877-ER Dose A: p = 0.3084, Mixed Model for repeated measures (MMRM)
K-877-IR vs K-877-ER Dose B: p = 0.5930, Mixed Model for repeated measures (MMRM)

Population analysed: The Per-Protocol Set (PPS) was defined as all patients in the Full Analysis Set without any major protocol deviations and who had baseline and Day 28 fasting serum TG measurements.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 28 Days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
K-877-IR	0 of 32 (0%)	0 of 32 (0%)	0 of 32
K-877-ER Dose A	0 of 32 (0%)	1 of 32 (3.1%)	0 of 32
K-877-ER Dose B	0 of 32 (0%)	5 of 32 (15.6%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dyslipidemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing K-877-ER (Dose A), K-877-ER (Dose B) and K-877-IR in people with Dyslipidemia, run by Kowa Research Institute, Inc. at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimated Percentage Change in Fasting Triglyceride(s) (TG) (time frame: Baseline to Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04447820.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.