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RecruitingNCT07229937Updated Dec 12, 2025

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

A Phase 2 interventional study of HRS-1301 and HRS-1301 in Hyperlipidemia, sponsored by Shandong Suncadia Medicine Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-12.

Sponsored by Shandong Suncadia Medicine Co., Ltd. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2025; still recruiting 10 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
189
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hyperlipidemia

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03

In context

Hyperlipidemias

821 studies on the registry are indexed under Hyperlipidemias; 105 are open to participants now.

This study's planned enrollment of 189 is above the median of 87 across 691 interventional studies indexed under Hyperlipidemias.

Browse Hyperlipidemias studies →

Lead sponsor

Shandong Suncadia Medicine Co., Ltd. is the lead sponsor of 86 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
189 participants (estimated)

Study arms

  • Experimental
    HRS-1301 Group A

    Drug: HRS-1301

  • Experimental
    HRS-1301 Group B

    Drug: HRS-1301

  • Experimental
    HRS-1301 Group C

    Drug: HRS-1301

  • Experimental
    HRS-1301 Group D

    Drug: HRS-1301

  • Experimental
    HRS-1301 Group E

    Drug: Placebo

Interventions

  • DrugHRS-1301

    HRS-1301 Dose 1，oral

  • DrugHRS-1301

    HRS-1301 Dose 2，oral

  • DrugHRS-1301

    HRS-1301 Dose 3，oral

  • DrugHRS-1301

    HRS-1301 Dose 4，oral

  • DrugPlacebo

    Placebo，oral

06

What researchers measure

Primary outcomes

  1. Percentage change in LDL-C relative to baseline

    Time frame: at 12 weeks of treatment

Secondary outcomes

  1. Proportion of subjects achieving LDL-C goals

    Time frame: at 12 weeks of treatment

  2. Percentage change in TC relative to baseline；

    Time frame: at 12 weeks of treatment

  3. Percentage change in HDL-C relative to baseline；

    Time frame: at 12 weeks of treatment

  4. Percentage change in TG relative to baseline；

    Time frame: at 12 weeks of treatment

  5. Percentage change in non-HDL-C relative to baseline；

    Time frame: at 12 weeks of treatment

  6. Percentage change in ApoB relative to baseline；

    Time frame: at 12 weeks of treatment

  7. Percentage change in ApoA1 relative to baseline；

    Time frame: at 12 weeks of treatment；

  8. Percentage change in Lp(a) relative to baseline；

    Time frame: at 12 weeks of treatment；

  9. Percentage change in hsCRP relative to baseline；

    Time frame: at 12 weeks of treatment；

  10. Number of participants with one or more adverse events

    Time frame: during the study period；Approximately half a year

07

Study locations

1 of 1 sites recruiting
  • The 2nd Affiliated Hospital of Harbin
    Harbin, Heilongjiang 150086, China
    • Bo Yu · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07229937
Lead sponsor
Shandong Suncadia Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Nov 17, 2025
Start date
Nov 25, 2025
Primary completion
Aug 2026 (estimated)
Completion
Aug 2026 (estimated)
Last update
Dec 12, 2025

Study contacts

Miaomiao Shi
Contact
Miaomiao.shi@hengrui.com
18036617171

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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