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

NCT07229937 | Recruiting Phase 2

• 1 other identifier: HRS-1301-201
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• Percentage change in LDL-C relative to baseline

  at 12 weeks of treatment

Secondary Outcomes (10)

• 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

Study Arms (5)

HRS-1301 Group A

EXPERIMENTAL

Drug: HRS-1301

HRS-1301 Group B

EXPERIMENTAL

Drug: HRS-1301

HRS-1301 Group C

EXPERIMENTAL

Drug: HRS-1301

HRS-1301 Group D

EXPERIMENTAL

Drug: HRS-1301

HRS-1301 Group E

EXPERIMENTAL

Drug: Placebo

Interventions

HRS-1301 DRUG

HRS-1301 Dose 1，oral

HRS-1301 Group A

Placebo DRUG

Placebo，oral

HRS-1301 Group E

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

The 2nd Affiliated Hospital of Harbin

Harbin, Heilongjiang, 150086, China

RECRUITING

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Miaomiao Shi

CONTACT

18036617171; Miaomiao.shi@hengrui.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: November 14, 2025
• First Posted: November 17, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-09

Locations

CN (1)