HRS-1301 for lowering high cholesterol (dyslipidemia)

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

This will test whether HRS-1301 can lower LDL cholesterol over 12 weeks in adults with high cholesterol or increased risk of heart disease.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 189 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shandong Suncadia Medicine Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Harbin, Heilongjiang)
• Trial ID: NCT07229937 on ClinicalTrials.gov

What this trial studies

This Phase II, 12-week interventional study gives adults with dyslipidemia one of several doses of HRS-1301 or placebo to explore a reasonable dosage and measure efficacy and safety. Eligible participants include adults with BMI ≥18 and either established ASCVD with LDL-C ≥1.8 mmol/L or intermediate-to-high ASCVD risk with LDL-C ≥2.6 mmol/L. Key exclusions include very high triglycerides (>5.6 mmol/L), homozygous familial hypercholesterolemia, recent acute ASCVD events, advanced heart failure, recent malignancy, or recent LDL/plasma apheresis. The trial is sponsored by Shandong Suncadia Medicine Co., Ltd. and conducted at The 2nd Affiliated Hospital of Harbin in Harbin, Heilongjiang, China.

Who should consider this trial

Good fit: Adults aged 18 or older with BMI ≥18 who have either ASCVD with LDL‑C ≥1.8 mmol/L or intermediate-to-high ASCVD risk with LDL‑C ≥2.6 mmol/L and who can attend the Harbin study site.

Not a fit: Patients with triglycerides >5.6 mmol/L, homozygous familial hypercholesterolemia, recent major cardiac events, advanced heart failure, recent cancers, or those on LDL/plasma apheresis are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, HRS-1301 could provide an additional option to lower LDL cholesterol and potentially reduce cardiovascular risk.

How similar studies have performed: Approved LDL‑lowering classes such as statins and PCSK9 inhibitors have proven benefit, but HRS-1301 appears to be a novel agent with limited prior published data.

Eligibility criteria

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

Where this trial is running

Harbin, Heilongjiang

• The 2nd Affiliated Hospital of Harbin — Harbin, Heilongjiang, China (Recruiting)

Study contacts

• Study coordinator: Miaomiao Shi

Conditions Hyperlipidemia