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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorQilu Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • QLC7401

    Drug

    QLC7401 combined with lipid-lowering agents

  • Placebo

    Drug

    Placebo combined with lipid-lowering agents

Treatment groups

780 Participants
are divided into 2 treatment groups
Group A: QLC7401 InjectionExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
From baseline to Day 330

Secondary outcomes

1

Time-adjusted Percent Change in Low Density Lipoprotein Cholesterol (LDL-C

Time frame
Day 90 to Day 360
2

Change in Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) from Baseline

Time frame
From baseline to Day 360
3

Incidence of Treatment-Emergent Adverse Events (TEAEs

Time frame
Throughout the study duration]

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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