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Recruiting NCT07229937

A Phase II Study To Evaluate the Efficacy And Safety Of HRS-1301 In Participants With Dyslipidemia

Phase II Interventional Hyperlipidemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HRS-1301, HRS-1301, HRS-1301, HRS-1301.
Who it may be relevant to
Registry conditions: Hyperlipidemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of HRS-1301 in Participants With Dyslipidemia

Overview

The purpose of the study is to explore the reasonable dosage of HRS-1301 in participants with dyslipidemia. The efficacy and safety of HRS-1301 will be evaluated after 12-weeks treatment.

Interventions

  • Drug HRS-1301
    HRS-1301 Dose 1，oral
  • Drug HRS-1301
    HRS-1301 Dose 2，oral
  • Drug HRS-1301
    HRS-1301 Dose 3，oral
  • Drug HRS-1301
    HRS-1301 Dose 4，oral
  • Drug Placebo
    Placebo，oral

Primary outcome measures

  • Percentage change in LDL-C relative to baseline [Time frame: at 12 weeks of treatment]
Secondary outcome measures (10)
  • Proportion of subjects achieving LDL-C goals [Time frame: at 12 weeks of treatment]
  • Percentage change in TC relative to baseline； [Time frame: at 12 weeks of treatment]
  • Percentage change in HDL-C relative to baseline； [Time frame: at 12 weeks of treatment]
  • Percentage change in TG relative to baseline； [Time frame: at 12 weeks of treatment]
  • Percentage change in non-HDL-C relative to baseline； [Time frame: at 12 weeks of treatment]
  • Percentage change in ApoB relative to baseline； [Time frame: at 12 weeks of treatment]
  • Percentage change in ApoA1 relative to baseline； [Time frame: at 12 weeks of treatment；]
  • Percentage change in Lp(a) relative to baseline； [Time frame: at 12 weeks of treatment；]
  • Percentage change in hsCRP relative to baseline； [Time frame: at 12 weeks of treatment；]
  • Number of participants with one or more adverse events [Time frame: during the study period；Approximately half a year]

Eligibility criteria

Inclusion criteria

  • Male and female ≥ 18 years old, who is able and willing to provide a written informed consent
  • BMI ≥ 18.0 kg/m2
  • Clinically diagnosed with ASCVD and LDL-C ≥ 1.8 mmol/L OR, if no history of ASCVD, has intermediate to high risk of developing ASCVD and LDL-C ≥ 2.6 mmol/L
  • Male and female subjects of childbearing potential and their partners must have no plans to donate sperm or become pregnant during the entire study period and for 2 weeks after the last dose, and agree to use contraceptive methods as specified in the protocol

Exclusion criteria

  • TG > 5.6 mmol/L
  • Diagnosed with homozygous familial hypercholesterolemia (HoFH)
  • Acute ischemic ASCVD events within 12 months before screening, or during the screening and run-in phase
  • Heart failure with New York Heart Association (NYHA) Class III-IV
  • Malignant tumors within 5 years
  • Received or is regularly receiving LDL or plasma apheresis within 12 months before screening
  • History or presence of severe gastrointestinal, hepatic, or renal diseases, or other known diseases that may interfere with drug absorption, distribution, metabolism, or excretion
  • Uncontrolled diabetes mellitus and/or hypertension
  • Has undergone transplantation of any vital organ, such as lung, liver, heart, bone marrow, or kidney

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The 2nd Affiliated Hospital of Harbin — Harbin

Identifiers

NCT: NCT07229937 · HRS-1301-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗