Primary Hypercholesterolemia or Mixed HyperlipidemiaPhase 3NCT07444086
QLC7401 Monotherapy in Non-familial Hypercholesterolemia or Mixed Dyslipidemia
A Phase 3 study testing QLC7401 in people with Primary Hypercholesterolemia or Mixed Hyperlipidemia, run by Qilu Pharmaceutical Co., Ltd..
Trial summary
This Phase III clinical trial aims to assess the efficacy and safety of QLC7401 monotherapy in adults with non-familial primary hypercholesterolemia or mixed dyslipidemia who are not receiving lipid-lowering therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Hypercholesterolemia or Mixed Hyperlipidemia
- What is being tested?
- QLC7401
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 510 participants
- Where
- No sites listed yet
- Study dates
- 5 Mar 2026to 28 Feb 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Efficacy and Safety of QLC7401 Monotherapy in Participants With Non-familial Primary Hypercholesterolemia or Mixed Dyslipidemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study
This Phase III clinical trial aims to assess the efficacy and safety of QLC7401 monotherapy in adults with non-familial primary hypercholesterolemia or mixed dyslipidemia who are not receiving lipid-lowering therapy. Participants will be randomly assigned to receive subcutaneous injections of either QLC7401 or a placebo according to the study schedule.
- Being tested
- QLC7401, Placebo
- Medical subject headings
- Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLC7401Drug
QLC7401 Injection
PlaceboDrug
Placebo matching QLC7401 in appearance and administration.
| Study group | Role | What they receive |
|---|---|---|
| QLC7401 | Experimental | Not described Receives: Drug: QLC7401 |
| Placebo Group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline
Measured: From baseline to Day 330
Secondary outcomes (3)
Time-adjusted Percent Change in Low Density Lipoprotein Cholesterol (LDL-C)
Measured: Day 90 to Day 360
Change in concentration of Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) from Baseline
Measured: From baseline to Day 360
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Measured: From baseline to Day 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start5 Mar 2026 (estimated)
- Primary completion7 Oct 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Hypercholesterolemia or Mixed HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 510 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444086
- Sponsor's protocol ID
- QLC7401-303
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety of QLC7401 Monotherapy in Participants With Non-familial Primary Hypercholesterolemia or Mixed Dyslipidemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study
- ClinicalTrials.gov ID
- NCT07444086
- Acronym / sponsor ID
- QLC7401-303
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 510 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Mar 2026 (estimated)
- Primary completion
- 7 Oct 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase III clinical trial aims to assess the efficacy and safety of QLC7401 monotherapy in adults with non-familial primary hypercholesterolemia or mixed dyslipidemia who are not receiving lipid-lowering therapy. Participants will be randomly assigned to receive subcutaneous injections of either QLC7401 or a placebo according to the study schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QLC7401 | Experimental | Drug: QLC7401 |
| Placebo Group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QLC7401QLC7401 Injection | Drug | QLC7401 |
| PlaceboPlacebo matching QLC7401 in appearance and administration. | Drug | Placebo Group |
Primary outcome
Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline
Time frame: From baseline to Day 330
3 secondary outcomes
Time-adjusted Percent Change in Low Density Lipoprotein Cholesterol (LDL-C)
Time frame: Day 90 to Day 360
Change in concentration of Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) from Baseline
Time frame: From baseline to Day 360
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From baseline to Day 360
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QLC7401 in people with Primary Hypercholesterolemia or Mixed Hyperlipidemia, run by Qilu Pharmaceutical Co., Ltd..
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 6 inclusion and 8 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: opening soon, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yue Li, PhD (8613945057313, hydy_liyue@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline (time frame: From baseline to Day 330). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2026.