Not Yet RecruitingPhase 3

QLC7401 in the Treatment of Primary Hypercholesterolemia or Mixed Hyperlipidemia With Elevated Low Density Lipoprotein Cholesterol (LDL-C)

780 participantsStarted 2026-03

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Percentage changes in Low Density Lipoprotein Cholesterol (LDL-C)

Timeframe: From baseline to Day 330

Trial details

NCT IDNCT07441317

SponsorQilu Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Jian an Wang, Doctorate

086-15990086511 wang_jian_an@vip.tom.com

View on ClinicalTrials.gov More Primary Hypercholesterolemia or Mixed Hyperlipidemia trials