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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hyperlipidemia
• Intervention / Treatment: Drug: HRS-1301; Drug: HRS-1301; Drug: HRS-1301; Drug: HRS-1301; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 189
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Miaomiao Shi; Phone Number: 18036617171; Email: Miaomiao.shi@hengrui.com

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150086
      • Recruiting
      • The 2nd Affiliated Hospital of Harbin
      • Principal Investigator: Bo Yu

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Male and female ≥ 18 years old, who is able and willing to provide a written informed consent
2. BMI ≥ 18.0 kg/m2
3. 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
4. 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:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HRS-1301 Group A	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
Experimental: HRS-1301 Group B	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
Experimental: HRS-1301 Group C	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
Experimental: HRS-1301 Group D	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
Experimental: HRS-1301 Group E	Drug: Placebo; Placebo，oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage change in LDL-C relative to baseline	at 12 weeks of treatment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shandong Suncadia Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Estimated): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Hyperlipidemias
• Other Study ID Numbers: HRS-1301-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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