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

NCT06750341 | Not Yet Recruiting Phase 2

• 1 other identifier: QLC7401-201
• Study Type: interventional
• Target: 156
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Primary Hypercholesterolemia or Mixed Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

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

  80 days and 270 days

Secondary Outcomes (11)

• 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

Study Arms (4)

QLC7401 100mg

EXPERIMENTAL

QLC7401 100 mg subcutaneous injection

Drug: QLC7401

QLC7401 300mg

EXPERIMENTAL

QLC7401 300 mg subcutaneous injection

Drug: QLC7401

QLC7401 500mg

EXPERIMENTAL

QLC7401 500 mg subcutaneous injection

Drug: QLC7401

Placebo

PLACEBO COMPARATOR

Placebo 100/300/500 mg subcutaneous injection

Drug: Placebo

Interventions

QLC7401 DRUG

QLC7401 combined with lipid-lowering agents

QLC7401 100mg; QLC7401 300mg; QLC7401 500mg

Placebo DRUG

Placebo combined with lipid-lowering agents

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Ming Zhao

CONTACT

086+15666662408; ming.zhao@qilu-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 27, 2024
• Study Start: February 1, 2025
• Primary Completion: June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 27, 2024

Record last verified: 2024-12