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

Shandong Suncadia Medicine

Status and phase: Enrolling; Phase 2

Conditions: Hyperlipidemia

Treatments: Drug: HRS-1301; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07229937

HRS-1301-201

Details and patient eligibility

About

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.

Enrollment: 189 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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189 participants in 5 patient groups

HRS-1301 Group A

Experimental group

Treatment:

Drug: HRS-1301

Drug: HRS-1301

Drug: HRS-1301

Drug: HRS-1301

HRS-1301 Group B

Experimental group

Treatment:

Drug: HRS-1301

Drug: HRS-1301

Drug: HRS-1301

Drug: HRS-1301

HRS-1301 Group C

Experimental group

Treatment:

Drug: HRS-1301

Drug: HRS-1301

Drug: HRS-1301

Drug: HRS-1301

HRS-1301 Group D

Experimental group

Treatment:

Drug: HRS-1301

Drug: HRS-1301

Drug: HRS-1301

Drug: HRS-1301

HRS-1301 Group E

Experimental group

Treatment:

Drug: Placebo