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

Phase 2

Not yet recruiting

• Conditions: Primary Hypercholesterolemia or Mixed Hyperlipidemia
• Interventions: Drug: QLC7401; Drug: Placebo

• Registration Number: NCT06750341
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-19
• Last Update Submitted: 2024-12-19
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Study Start: 2025-02
• Primary Completion: 2026-06
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

• 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.
• 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 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QLC7401 500mg	QLC7401	QLC7401 500 mg subcutaneous injection
QLC7401 100mg	QLC7401	QLC7401 100 mg subcutaneous injection
QLC7401 300mg	QLC7401	QLC7401 300 mg subcutaneous injection
Placebo	Placebo	Placebo 100/300/500 mg subcutaneous injection

Primary Outcome Measures

Name	Time	Method
Percentage changes in LDL-C from baseline to Day 180 and Day 270	80 days and 270 days

Secondary Outcome Measures

Name	Time	Method
Percentage changes in LDL-C from baseline at each subsequent visit to Day 360	360 days
Value changes in LDL-C from baseline at each subsequent visit to Day 360	360 days
Percentage changes in PCSK9 from baseline at each subsequent visit to Day 360	360 days
Value changes in PCSK9 from baseline at each subsequent visit to Day 360	360 days
Percentage changes in non-HDL-C, Apo B, TC/HDL-C, Apo A1, Apo B/Apo A1, Lp (a), and TG from baseline to Day 180, Day 270, and Day 360	360 days
Value changes in non-HDL-C, Apo B, TC/HDL-C, Apo A1, Apo B/Apo A1, Lp (a), and TG from baseline to Day 180, Day 270, and Day 360	360 days
Proportion of participants with LDL-C greater than 80% of baseline value at Day 180, Day 210, Day 270, and Day 360	360 days
Duration of treatment for participants to return to 80% of baseline value or greater LDL-C or PCSK9 protein	360 days
Proportion of participants who attained global lipid modification targets for level of ASCVD risk	360 days
Number of participants with adverse events and injection site reactions, with abnormal vital signs, abnormal physical examination, abnormal 12-ECG, abnormal laboratory assessments	360 days
ADA incidence	360 days