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New Cholesterol-Lowering drug HRS-1301 enters Mid-Stage trial

NCT ID NCT07229937

Disease control Sponsor: Shandong Suncadia Medicine Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests an experimental drug called HRS-1301 in people with high cholesterol (dyslipidemia). About 189 participants will receive one of four doses of HRS-1301 or a placebo daily for 12 weeks. The main goal is to see how much the drug lowers 'bad' LDL cholesterol and to find the best dose.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HRS-1301 (an experimental oral drug to lower cholesterol)
What this could lead to
If successful, this could provide a new treatment option for managing high cholesterol and reducing heart disease risk.
What could go wrong
This is an early Phase 2 trial with only 189 participants, so results may not apply to everyone. The drug may not work better than existing treatments or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 189 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

hyperlipidemia inherited lipid metabolism disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hyperlipidemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The 2nd Affiliated Hospital of Harbin

    RECRUITING

    Harbin, Heilongjiang, 150086, China

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