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HyperlipidemiaPhase 3NCT04998981

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

A Phase 3 study testing K-877 0.1 mg tablet and Fenofibrate 200 mg capsule in people with Hyperlipidemia, run by Kowa Company, Ltd. at 33 sites in China.

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 Phase 3 Study to Evaluate the Efficacy and Safety of K-877 in Chinese Patients with High TG and Low HDL-C Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hyperlipidemia
What is being tested?
K-877 0.1 mg tablet and Fenofibrate 200 mg capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
353 participants
Where
33 sitesChina
Study dates
17 Sep 2021to 2 Feb 2023
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Subjects are eligible to be included in the study only if all of the following criteria apply:
  • Ability to understand and comply with study procedures and give written informed 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.

Who cannot join

  • Subjects are excluded from the study if any of the following criteria apply:
  • Current or planned use of any lipid-altering medications other than the study drugs, statins, or ezetimibe during the study.
  • 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
  • For subjects currently on lipid-altering medications other than statins or 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
Show all 16Show fewer
  • 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

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

China33 sites

  • Huainan First People's Hospital

    Anhui, 232000

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, 100029

  • Beijing Hospital

    Beijing, 100730

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, 100730

  • Beijing Pinggu Hospital

    Beijing, 101200

  • Chengdu Xinhua Hospital

    Chengdu, 610066

  • The First Affiliated Hospital of Fujian Medical University

    Fujian, 350005

  • Peking Union Medical College Hospital

    Guangdong, 100032

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangdong, 510080

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangdong, 510120

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Guangxi, 530021

  • Hainan General Hospital

    Hainan, 570311

  • The Second Hospital of Hebei Medical University

    Hebei, 050000

  • The First Affiliated Hospital of Harbin Medical University

    Helongjiang, 150001

  • Union Hospital, Tongji Medical College of Huazhong University of Science & Technology

    Hubei, 430022

  • Tongji Hospital, Tongji Medical College of HUST

    Hubei, 430030

  • Shaanxi Provincial People's Hospital

    Hubei, 710068

  • The Third Xiangya Hospital of Central South University

    Hunan, 410013

  • The Third Hospital of Changsha

    Hunan, 410015

  • Nanjing Jiangning Hospital

    Jiangsu, 211100

  • Sir Run Run Hospital Nanjing Medical Universtiy

    Jiangsu, 211100

  • Affiliated Hospital of Jiangsu University

    Jiangsu, 212001

  • Jiangxi Provincial People's Hospital

    Jiangxi, 330006

  • The First Affiliated Hospital of Nanchang University

    Jiangxi, 330006

  • The First Hospital of Nanchang

    Jiangxi, 330008

  • Jiu Jiang No. 1 People's Hospital

    Jiangxi, 332000

  • Pingxiang People's Hospital

    Jiangxi, 337055

  • China-Japan Union Hospital of Jilin University

    Jilin City, 330006

  • Shanghai Tongren Hospital

    Shanghai, 200336

  • People's Hospital of Deyang City

    Sichuan, 618000

  • Tianjin Union Medical Center

    Tianjin, 300121

  • The Affiliated Hospital of Hangzhou Normal University

    Zhejiang, 310015

  • People's Hospital of Wenzhou City

    Zhejiang, 325000

Other trials in China

About this study

Official title: A Phase 3, Multi-Center, Placebo- and Active-Controlled, Randomized, Double-Blind, 12-Week Study to Evaluate the Efficacy and Safety of K-877 in Chinese Patients With High TG and Low HDL-C

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

Conditions
Hyperlipidemia
Being tested
K-877 0.1 mg tablet, Fenofibrate 200 mg capsule, Placebo tablet, Placebo capsule
Medical subject headings
Hyperlipidemias

What participants receive

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

  • K-877 0.1 mg tabletDrug

    Also called Pemafibrate

    K-877 0.1 mg tablet x 2 twice daily

  • Fenofibrate 200 mg capsuleDrug

    Fenofibrate 200 mg capsule once daily

  • Placebo tabletDrug

    Also called Placebo tablet (matching K-877)

    Placebo tablet x 2 twice daily

  • Placebo capsuleDrug

    Also called Placebo capsule (matching fenofibrate)

    Placebo capsule once daily

  • K-877 0.1 mg tabletDrug

    Also called Pemafibrate

    K-877 0.1 mg tablet twice daily

  • Placebo tabletDrug

    Also called Placebo tablet (matching K-877)

    Placebo tablet twice daily

Study groups in NCT04998981
Study groupRoleWhat they receive
K-877 0.1 mg BIDExperimentalK-877 0.1 mg tablet twice daily, Placebo tablet twice daily, Placebo capsule once daily
Receives: Drug: Placebo capsule; Drug: K-877 0.1 mg tablet; Drug: Placebo tablet
K-877 0.2 mg BIDExperimentalK-877 0.1 mg tablet x 2 twice daily, Placebo capsule once daily
Receives: Drug: K-877 0.1 mg tablet; Drug: Placebo capsule
Fenofibrate 200 mg QDActive comparatorFenofibrate 200 mg capsule once daily, Placebo tablet x 2 twice daily
Receives: Drug: Fenofibrate 200 mg capsule; Drug: Placebo tablet
PlaceboPlacebo comparatorPlaccebo tablet x 2 twice daily, Placebo capsule once daily
Receives: Drug: Placebo tablet; Drug: Placebo capsule

What is being measured

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

  1. Percent change in fasting TG versus placebo from baseline to Weeks 8 and 12

    Measured: From baseline to Weeks 8 and 12

  2. Percent change in fasting TG versus fenofibrate from baseline to Weeks 8 and 12

    Measured: From baseline to Weeks 8 and 12

Secondary outcomes (8)

  1. Percentage of patients who have achieved fasting TG <150 mg/dL at the end of the treatment period

    Measured: At Week 12

  2. Percent change from baseline to Weeks 8 and 12 in TC, LDL-C (direct method), LDL-C (Friedewald method), LDL-C (Martin/Hopkins equation), HDL-C (direct method), non-HDL-C (calculated), and remnant cholesterol (calculated)

    Measured: From baseline to Weeks 8 and 12

  3. Change from baseline to Weeks 8 and 12 in fasting TG, TC, LDL-C (direct method), LDL-C (Friedewald method), LDL-C (Martin/Hopkins equation), HDL-C (direct method), non-HDL-C (calculated), and remnant cholesterol (calculated)

    Measured: From baseline to Weeks 8 and 12

  4. Percent change from baseline to the end of the treatment period in Apo A1 and Apo B

    Measured: From baseline to Week 12

  5. Percent change from baseline to the end of the treatment period in TG/HDL-C, TC/HDL-C, non-HDL-C/HDL-C, LDL-C/HDL-C, LDL-C/Apo B, and Apo B/Apo A1

    Measured: From baseline to Week 12

  6. The incidence of adverse events and adverse drug reactions after the administration of the study drug

    Measured: Up to Week 12

  7. Change from baseline to Week 4, 8, and 12 in clinical laboratory tests (chemistry, hematology), vital signs (BP [mmHg], PR [bpm], weight [kg], waist [cm], and BMI [kg/m^2]; each parameter is evaluated individually.), 12-lead ECGs

    Measured: From baseline to Week 4, 8, and 12

  8. Number and percentage of patients who experience laboratory abnormalities of special interest including, but not limited to ALT, AST, ALP, CK, and, creatinine during the treatment period

    Measured: Up to Week 12

Timeline

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

  1. First posted10 Aug 2021
  2. Study start17 Sep 2021
  3. Primary completion2 Feb 2023
  4. Study completion2 Feb 2023

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
353 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04998981
Sponsor's protocol ID
K-877-3.01CH
Status last verified
May 2025
First submitted
14 Jul 2021
Last updated
23 May 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Dai W, Lv Q, Li Q, Fu L, Zhang Y, Zhang Y, Liu L, Tanigawa R, Kunitomi K, Kamei R, Suganami H, Ma C. Efficacy and Safety of Pemafibrate, a Novel Selective PPARalpha Modulator in Chinese Patients with Dyslipidemia: A Double-Masked, Randomized, Placebo- and Active-Controlled Comparison Trial. J Atheroscler Thromb. 2025 Feb 1;32(2):125-140. doi: 10.5551/jat.64112. Epub 2024 Aug 2.

    PubMed 39098034

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing K-877 0.1 mg tablet and Fenofibrate 200 mg capsule in people with Hyperlipidemia, run by Kowa Company, Ltd. at 33 sites in China.

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 7 inclusion and 16 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 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in China. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percent change in fasting TG versus placebo from baseline to Weeks 8 and 12 (time frame: From baseline to Weeks 8 and 12). The study lists 2 primary outcomes in all. 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 NCT04998981, which also lists 1 linked publication.

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 23 May 2025.

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