HyperlipidemiaPhase 2NCT07229937
A Phase II Study To Evaluate the Efficacy And Safety Of HRS-1301 In Participants With Dyslipidemia
A Phase 2 study testing HRS-1301 in people with Hyperlipidemia, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- HRS-1301
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 189 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2025to Aug 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The 2nd Affiliated Hospital of Harbin
Harbin, Heilongjiang, 150086
Bo Yu
About this study
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
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
- Being tested
- HRS-1301, Placebo
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-1301Drug
HRS-1301 Dose 1，oral
HRS-1301Drug
HRS-1301 Dose 2，oral
HRS-1301Drug
HRS-1301 Dose 3，oral
HRS-1301Drug
HRS-1301 Dose 4，oral
PlaceboDrug
Placebo，oral
| Study group | Role | What they receive |
|---|---|---|
| HRS-1301 Group A | Experimental | Not described Receives: Drug: HRS-1301 |
| HRS-1301 Group B | Experimental | Not described Receives: Drug: HRS-1301 |
| HRS-1301 Group C | Experimental | Not described Receives: Drug: HRS-1301 |
| HRS-1301 Group D | Experimental | Not described Receives: Drug: HRS-1301 |
| HRS-1301 Group E | Experimental | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in LDL-C relative to baseline
Measured: at 12 weeks of treatment
Secondary outcomes (10)
Proportion of subjects achieving LDL-C goals
Measured: at 12 weeks of treatment
Percentage change in TC relative to baseline；
Measured: at 12 weeks of treatment
Percentage change in HDL-C relative to baseline；
Measured: at 12 weeks of treatment
Percentage change in TG relative to baseline；
Measured: at 12 weeks of treatment
Percentage change in non-HDL-C relative to baseline；
Measured: at 12 weeks of treatment
Percentage change in ApoB relative to baseline；
Measured: at 12 weeks of treatment
Percentage change in ApoA1 relative to baseline；
Measured: at 12 weeks of treatment；
Percentage change in Lp(a) relative to baseline；
Measured: at 12 weeks of treatment；
Percentage change in hsCRP relative to baseline；
Measured: at 12 weeks of treatment；
Number of participants with one or more adverse events
Measured: during the study period；Approximately half a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start25 Nov 2025
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 189 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229937
- Sponsor's protocol ID
- HRS-1301-201
- Status last verified
- Sep 2025
- First submitted
- 14 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07229937
- Acronym / sponsor ID
- HRS-1301-201
- Conditions
- Hyperlipidemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-1301HRS-1301 Dose 1，oral | Drug | HRS-1301 Group A |
| HRS-1301HRS-1301 Dose 2，oral | Drug | HRS-1301 Group B |
| HRS-1301HRS-1301 Dose 3，oral | Drug | HRS-1301 Group C |
| HRS-1301HRS-1301 Dose 4，oral | Drug | HRS-1301 Group D |
| PlaceboPlacebo，oral | Drug | HRS-1301 Group E |
Primary outcome
Percentage change in LDL-C relative to baseline
Time frame: at 12 weeks of treatment
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRS-1301 in people with Hyperlipidemia, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miaomiao Shi (18036617171, Miaomiao.shi@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in LDL-C relative to baseline (time frame: at 12 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.