New combo pill aims to tackle cholesterol in metabolic syndrome patients
NCT ID NCT07523971
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing a fixed-dose combination of two cholesterol-lowering drugs (Pitavastatin and Ezetimibe) in 10,000 adults with high cholesterol and metabolic syndrome. Researchers will track how much LDL ('bad') cholesterol drops after 24 and 48 weeks of treatment in real-world clinics. The goal is to see if this pill works well and is safe for everyday use.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pitavastatin/Ezetimibe combination tablet
- What this could lead to
- If successful, this could confirm that the combination pill effectively lowers cholesterol in real-world patients with metabolic syndrome, supporting its routine use.
- What could go wrong
- This is an observational study, not a controlled trial, so results may be influenced by other factors. The study is large but early in real-world testing, and individual responses may vary.
Why investors are watching
JW Pharmaceutical is running a large observational study of its fixed-dose Pitavastatin/Ezetimibe tablet in 10,000 patients with dyslipidemia and metabolic syndrome. For a small-cap company, this real-world readout on cholesterol reduction and safety over 48 weeks could shape how doctors prescribe the drug and how the product competes.
If it works: A positive result could strengthen the drug's position in a crowded cholesterol market and support broader use in routine care. That could help JW Pharmaceutical grow sales of a key product.
If it fails: Observational studies can produce mixed or weak results, and the company has no control over how doctors treat patients. If the data show limited benefit or safety concerns, the product could lose credibility, and the company would have spent resources without a clear payoff.
AI-written from the trial record. Speculative, and not investment advice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 10,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Dyslipidemia Who Also Have Metabolic Syndrome
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 19 years old at the time of written informed consent 2. Subjects diagnosed with dyslipidemia and metabolic syndrome 3. Subjects who had no treatment history with lipid regulators within 4 weeks prior to Visit1 or who had insufficient therapeutic effects from 8 weeks of treatment with lipid regulators using the same dosage and administration 4. Subjects who meet the following LDL-C levels according to the classification of cardiovascular disease risk groups\* at Visit 1 or who are planned to be treated with Pitavastatin/Ezetimibe Tablets based on the judgment of the investigator 5. Subjects who voluntarily sign the informed consent form for study participation Exclusion Criteria: 1. Individuals for whom Pitavastatin/Ezetimibe Tablets is contraindicated as specified in the label's Precautions for Use 2. Individuals who were treated with other investigational products (IP) or investigational devices within 4 weeks prior to participation in the present study or who are expected to have such treatment during the present study 3. Individuals who are considered to have difficulty participating in the study for other reasons based on the judgment of the investigator
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chungnam National University Hospita
RECRUITINGDaejeon, South Korea
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