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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Percentage change in LDL-C relative to baseline [Срок оценки: at 12 weeks of treatment]

Вторичные конечные точки (10)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The 2nd Affiliated Hospital of Harbin — Харбин

Идентификаторы

NCT: NCT07229937 · HRS-1301-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗