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

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of Different Doses 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, 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Hypercholesterolemia or Mixed Hyperlipidemia
• Intervention / Treatment: Drug: QLC7401; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 156
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ming Zhao; Phone Number: 086+15666662408; Email: ming.zhao@qilu-pharma.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QLC7401 100mg; QLC7401 100 mg subcutaneous injection	Drug: QLC7401; QLC7401 combined with lipid-lowering agents
Experimental: QLC7401 300mg; QLC7401 300 mg subcutaneous injection	Drug: QLC7401; QLC7401 combined with lipid-lowering agents
Experimental: QLC7401 500mg; QLC7401 500 mg subcutaneous injection	Drug: QLC7401; QLC7401 combined with lipid-lowering agents
Placebo Comparator: Placebo; Placebo 100/300/500 mg subcutaneous injection	Drug: Placebo; Placebo combined with lipid-lowering agents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage changes in LDL-C from baseline to Day 180 and Day 270	80 days and 270 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: December 16, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Lipid Metabolism, Inborn Errors; Hypertriglyceridemia; Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemias; Lipidoses; Hyperlipidemia, Familial Combined; Hyperlipoproteinemia Type V
• Other Study ID Numbers: QLC7401-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No