Study of QLC7401 in the Treatment of Primary Hypercholesterolemia or Mixed Hyperlipidemia With Elevated LDL Cholesterol

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorQilu Pharmaceutical Co., Ltd.

About this trial

To evaluate the efficacy, safety, pharmacodynamics and immunogenicity of QLC7401 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 LDL-C ≥1.8mmol/L for ASCVD participants or ≥2.6mmol/L for other participants at screening.

Fasting 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 II-IV at screening or randomization or latest detected LVEF<30%; (2) CVD events 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 2 times the upper limit of normal (ULN), or total bilirubin exceeding 1.5 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

156 Participants
are divided into 4 treatment groups
Group A: QLC7401 100mgExperimental treatment 1 intervention
Group B: QLC7401 300mgExperimental treatment 1 intervention
Group C: QLC7401 500mgExperimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage changes in LDL-C from baseline to Day 180 and Day 270

Time frame
80 days and 270 days

Secondary outcomes

1

Percentage changes in LDL-C from baseline at each subsequent visit to Day 360

Time frame
360 days
2

Value changes in LDL-C from baseline at each subsequent visit to Day 360

Time frame
360 days
3

Percentage changes in PCSK9 from baseline at each subsequent visit to Day 360

Time frame
360 days
4

Value changes in PCSK9 from baseline at each subsequent visit to Day 360

Time frame
360 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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