New shot could tame high cholesterol without daily pills
NCT ID NCT07444086
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 3 trial tests a new injectable drug called QLC7401 in 510 adults with high cholesterol or mixed dyslipidemia who are not on other cholesterol treatments. Participants receive either the drug or a placebo as a shot under the skin. The main goal is to see how much it lowers 'bad' LDL cholesterol over time. Researchers will also check safety and side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- QLC7401 injection
- What this could lead to
- If successful, this could provide a new injectable treatment option to help control high cholesterol and reduce heart disease risk.
- What could go wrong
- This is an early-stage Phase 3 trial, so results are not yet known. The drug may not lower cholesterol enough or could cause side effects. It is only tested in people not on other cholesterol meds.
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.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 510 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2028
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.
- Ages
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18 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Aged ≥18 years. * Fasting low density lipoprotein cholesterol (LDL-C) ≥2.6 mmol/L and \<4.9 mmol/L at screening. * Atherosclerotic cardiovascular disease (ASCVD) risk stratification as low or intermediate risk per Chinese guidelines. * Not currently on lipid-lowering therapy. * estimated Glomerular Filtration Rate (eGFR) \>30 mL/min/1.73 m². * Willing to provide informed consent. Exclusion Criteria: * History of AAtherosclerotic cardiovascular disease (ASCVD)(e.g., myocardial infarction, stroke). * Familial hypercholesterolemia. * Uncontrolled hypertension (Systolic Blood Pressure ≥160 mmHg or (Diastolic Blood Pressure ≥100 mmHg). * Poorly controlled type 2 diabetes (Glycated Haemoglobin A1c \>8.0%). * Use of prohibited lipid-lowering drugs within specified washout periods. * Significant liver or kidney disease. * Pregnancy or lactation. * Other conditions deemed unsuitable by 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 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.
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Other studies related to the condition(s) this trial covers.