Primary Hypercholesterolemia or Mixed HyperlipidemiaPhase 3NCT07441317
QLC7401 in the Treatment of Primary Hypercholesterolemia or Mixed Hyperlipidemia With Elevated Low Density Lipoprotein Cholesterol (LDL-C)
A Phase 3 study testing QLC7401 in people with Primary Hypercholesterolemia or Mixed Hyperlipidemia, run by Qilu Pharmaceutical Co., Ltd..
Trial summary
To evaluate the efficacy, safety and immunogenicity of QCL7401 subcutaneous administration in patients with primary hypercholesterolemia or mixed hyperlipidemia with poorly controlled LDL-C elevated on optimized 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
- 780 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Mar 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
- Male or female participants aged ≥18 years of age.
- 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.
- Fasting Total Cholesterol (TG) ≤400mg/dL (≤4.5mmol/L) at screening.
- Stable lipid-lowering therapy for ≥4 weeks at randomization.
- Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent.
Who cannot join
- 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.
- 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.
- 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.
- The investigator determines that the participants have poor compliance or have any factors that may prevent them from participating in the study.
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: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of QLC7401 in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia With Poorly Controlled Low-density Lipoprotein Cholesterol (LDL-C) Elevated on Optimized Lipid-lowering Therapy
To evaluate the efficacy, safety and immunogenicity of QCL7401 subcutaneous administration in patients with primary hypercholesterolemia or mixed hyperlipidemia with poorly controlled LDL-C elevated on optimized lipid-lowering therapy.
- 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 combined with lipid-lowering agents
PlaceboDrug
Placebo combined with lipid-lowering agents
| Study group | Role | What they receive |
|---|---|---|
| QLC7401 Injection | Experimental | Participants receive QLC7401 at a pre-defined dosage via subcutaneous injection according to the study schedule. Receives: Drug: QLC7401 |
| Placebo | Placebo comparator | Participants receive placebo via subcutaneous injection according to the study schedule. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage changes in Low Density Lipoprotein Cholesterol (LDL-C)
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 Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) from Baseline
Measured: From baseline to Day 360
Incidence of Treatment-Emergent Adverse Events (TEAEs
Measured: Throughout the study duration]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionMar 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
- 780 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
- NCT07441317
- Sponsor's protocol ID
- QLC7401-301
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of QLC7401 in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia With Poorly Controlled Low-density Lipoprotein Cholesterol (LDL-C) Elevated on Optimized Lipid-lowering Therapy
- ClinicalTrials.gov ID
- NCT07441317
- Acronym / sponsor ID
- QLC7401-301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 780 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 27 Feb 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.
To evaluate the efficacy, safety and immunogenicity of QCL7401 subcutaneous administration in patients with primary hypercholesterolemia or mixed hyperlipidemia with poorly controlled LDL-C elevated on optimized lipid-lowering therapy.
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 Injection | Experimental | Drug: QLC7401Participants receive QLC7401 at a pre-defined dosage via subcutaneous injection according to the study schedule. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants receive placebo via subcutaneous injection according to the study schedule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female participants aged ≥18 years of age.
- 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.
- Fasting Total Cholesterol (TG) ≤400mg/dL (≤4.5mmol/L) at screening.
- Stable lipid-lowering therapy for ≥4 weeks at randomization.
- Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent.
Key exclusion criteria (4 listed)
- 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.
- 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.
- 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.
- The investigator determines that the participants have poor compliance or have any factors that may prevent them from participating in the study.
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 combined with lipid-lowering agents | Drug | QLC7401 Injection |
| PlaceboPlacebo combined with lipid-lowering agents | Drug | Placebo |
Primary outcome
Percentage changes in Low Density Lipoprotein Cholesterol (LDL-C)
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 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: Throughout the study duration]
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 4 Mar 2026.
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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 5 inclusion and 4 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 4 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 Jian an Wang, Doctorate (086-15990086511, wang_jian_an@vip.tom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage changes in Low Density Lipoprotein Cholesterol (LDL-C) (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 4 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.