A Phase 3 Study to Evaluate the Efficacy and Safety of K-877 in Chinese Patients With High TG and Low HDL-C

  • STATUS
    Recruiting
  • days left to enroll
    5
  • participants needed
    350
  • sponsor
    Kowa Company, Ltd.
Updated on 18 December 2021
fasting
fenofibrate

Summary

A Phase 3 Study to Evaluate the Efficacy and Safety of K-877 in Chinese Patients with High TG and Low HDL-C

Details
Condition Hyperlipidemia
Treatment Placebo Capsule, Placebo tablet, K-877 0.1 mg tablet, Fenofibrate 200 mg capsule
Clinical Study IdentifierNCT04998981
SponsorKowa Company, Ltd.
Last Modified on18 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects are eligible to be included in the study only if all of the following criteria
Ability to understand and comply with study procedures and give written informed
apply
consent
Following the diet and lifestyle recommendations at least 12 weeks prior to the
treatment period
Males or post-menopausal females
Aged ≥18 years at the time of informed consent
Fasting serum TG levels ≥200 mg/dL (≥2.26 mmol/L) and ≤500 mg/dL (5.65 mmol/L) at
screening
Serum HDL-C <50 mg/dL (<1.30 mmol/L) if male or <55 mg/dL (<1.42 mmol/L) if female at
screening

Exclusion Criteria

Subjects are excluded from the study if any of the following criteria apply
ii. For subjects currently on lipid-altering medications other than statins or
Current or planned use of any lipid-altering medications other than the study drugs
statins, or ezetimibe during the study
i. Subjects currently on statins or ezetimibe must be at high risk for atherosclerotic
CV diseases, and the dose(s) must be stable for at least 4 weeks prior to screening
ezetimibe, at least 4-week washout period (or for subjects currently on probucol at
least 8 week washout period) will be required prior to the first fasting blood
sampling at Screening Visit
Type 1 diabetes mellitus or poorly controlled Type 2 diabetes mellitus defined by
HbA1c (NGSP level) ≥8.0% at screening
Uncontrolled hypertension defined by seated systolic blood pressure ≥160 mmHg and/or
diastolic blood pressure ≥100 mmHg at screening
Uncontrolled thyroid disorder
Creatinine ≥1.5 mg/dL at screening
Severe hepatic disorder defined as cirrhosis of Child-Pugh class B or C, or AST or ALT
>2 × ULN at screening
History of pancreatitis
Gallbladder disorder, history of cholelithiasis, primary biliary cirrhosis, or history
of disease or surgery that may affect the absorption, distribution, metabolism and
excretion of drugs or the metabolism of bile salts
Unexplained creatine kinase (CK) >5 × ULN at screening
Myocardial infraction or stroke (including transient ischemic attack) within 3 months
prior to the informed consent
New York Heart Association Class III or IV heart failure
History of malignancy within 5 years
Participation in another clinical study at the time of informed consent or
administration of an investigational drug other than placebo within 16 weeks prior to
the informed consent for this study
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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