New cholesterol drug QLC7401 enters final testing phase
NCT ID NCT07441317
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 3 trial tests a new drug called QLC7401 in about 780 adults with high cholesterol that remains high despite standard therapy. Participants will receive either QLC7401 or a placebo, added to their current cholesterol medications. The main goal is to see if QLC7401 can safely lower LDL ('bad') cholesterol levels.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- QLC7401
- What this could lead to
- If it works, this could offer a new option for people with high cholesterol that isn't controlled by current medications.
- 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 have side effects.
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
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 780 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Mar 2026
An estimate. Start dates often move.
- Expected to finish
-
Mar 2028
An estimate. End dates often move.
- Lead sponsor
-
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
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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. Male or female participants aged ≥18 years of age. 2. Serum low density lipoprotein cholesterol (LDL-C) ≥1.8mmol/L for participants with atherosclerotic cardiovascular disease (ASCVD) or ≥2.6mmol/L for other participants at screening. 3. Fasting Total Cholesterol (TG) ≤400mg/dL (≤4.5mmol/L) at screening. 4. Stable lipid-lowering therapy for ≥4 weeks at randomization. 5. Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent. Exclusion Criteria: 1. Having the following diseases or treatment history: (1) cardiac function as defined by the New York Heart Association (NYHA) grade III-IV at screening or randomization ; (2) Cardiovascular diseases within 3 months; (3) uncontrolled severe hypertension; (4) previous diagnosis of familial hypercholesterolemia; (5) have known allergic reaction to experimental drug, or have severe allergic reaction to other drugs; (6) inadequate organ functions or malignancy history; (7) prior exposure to other RNA inhibitors within 2 years. 2. Any of the laboratory indicators met the following criteria at screening or at randomization: (1) ALT or AST exceeding 3 times the upper limit of normal (ULN), or total bilirubin exceeding 2 times ULN; (2) creatine kinase (CK) exceeding 3 times ULN; (3) TSH is less than the lower limit or normal (LLN) or exceeds 1.5 times ULN. 3. General conditions: (1) male or female participants who do not agree to use high-efficiency contraceptives during the trial and for 6 months after the last dosing; (2) women who are pregnant or lactating. 4. The investigator determines that the participants have poor compliance or have any factors that may prevent them from participating in the study.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Mixed hyperlipidemia are added.
By submitting, you agree to our Terms of use
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.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.