A Study of SYH2070 Injection in Participants With Mixed Hyperlipidemia

NCT07695597 | Recruiting Phase 2

• 1 other identifier: SYH2070-004
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, placebo-parallel, multicenter phase II clinical trial to evaluate the efficacy and safety of SYH2070 injection in participants with mixed hyperlipidemia.

Conditions

Mixed Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• The percentage change in serum TG levels from baseline at week 24

  Baseline through Week 24

Study Arms (6)

SYH2070, 150 mg

EXPERIMENTAL

Drug: SYH2070

SYH2070, 150 mg placebo

PLACEBO COMPARATOR

Drug: Placebo

SYH2070, 300 mg

EXPERIMENTAL

Drug: SYH2070

SYH2070, 300 mg placebo

PLACEBO COMPARATOR

Drug: Placebo

SYH2070, 400 mg

EXPERIMENTAL

Drug: SYH2070

SYH2070, 400 mg placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SYH2070 DRUG

SYH2070 injection, 150 mg, 300 mg, 400 mg, SC, administration duration: 24 weeks

SYH2070, 150 mg; SYH2070, 300 mg; SYH2070, 400 mg

Placebo DRUG

Placebo, SC, administration duration: 24 weeks

SYH2070, 150 mg placebo; SYH2070, 300 mg placebo; SYH2070, 400 mg placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old, no gender limitation;
• mmol/L (150 mg/dL) ≤ fasting TG ≤ 5.6 mmol/L (499 mg/dL) at screening;
• fasting LDL-C ≥ 2.6 mmol/L (100 mg/dL) at screening;
• Participants must have been continuously taking stable medium-intensity or higher statin drugs for at least 4 weeks, accompanied or not by cholesterol absorption inhibitors or fibrates, and maintain the same drug, dosage, frequency and brand throughout the trial period;
• Weight index range: 18.5 kg/m2 ≤ BMI ≤ 40.0 kg/m2 at screening;
• Understand the trial procedures and methods, voluntarily participate in this trial and sign the ICF in person;
• Male participants with reproductive capacity and their partners who are reproductive-aged women must agree to use highly effective contraceptive measures during the trial period and 24 weeks after the last administration of the trial drug; serum pregnancy tests before medication, serum or urine pregnancy tests during the trial period must be negative, and not be in the lactation period; participants are not allowed to donate sperm or eggs during the trial period and 24 weeks after the last administration of the trial drug.

You may not qualify if:

• Genetic diagnosis or clinical diagnosis indicates homozygous familial hypercholesterolemia;
• During the screening or before randomization, there is NYHA-defined heart function grade Ⅲ-Ⅳ or known left ventricular ejection fraction \< 30%;
• Within 3 months before the screening, there has been a new major cardiovascular adverse event, including acute coronary syndrome (such as myocardial infarction, unstable angina pectoris), cerebrovascular disease history (such as acute stroke or transient ischemic attack), or acute pulmonary embolism;
• Within 3 months before the screening, there are clinically significant arrhythmias, such as recurrent and symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular rate, atrial flutter with rapid ventricular rate, third-degree atrioventricular block, sinus arrest, etc.), drug or ablation-induced arrhythmias that cannot be controlled;
• Within 1 month before the screening, there is a history of percutaneous coronary intervention or peripheral artery revascularization surgery;
• At screening, there is poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg);
• Previously diseases that significantly affect lipid levels, such as nephrotic syndrome, severe liver diseases, Cushing's syndrome, etc.;
• Previously diagnosed with type 1 diabetes, or type 2 diabetes HbA1c \> 8.5% at screening ;
• Within 1 year before the screening, there is a history of acute or chronic pancreatitis;
• Within 5 years before the screening, there is a history of malignant tumor (excluding well-treated basal cell skin cancer and cervical carcinoma in situ);
• Within 3 months before the screening, there is a history of major surgery (including coronary artery bypass grafting surgery) or planned major surgery during the trial;
• Plan to undergo percutaneous coronary intervention, coronary artery bypass grafting, carotid or peripheral artery revascularization, pacemaker implantation, cardiac resynchronization therapy, implantation of implantable cardioverter-defibrillator, etc. during the trial;
• At the time of screening or before randomization, there is an active infectious disease that the investigator deems not suitable for participation in the trial;
• Previously had a history of drug abuse, alcohol abuse, or drug addiction;
• Known to be allergic to the test drugs or have a severe allergic reaction to other small nucleic acid drugs;

Sponsors & Collaborators

• CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.: lead

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): September 10, 2027
• Last Updated: July 22, 2026

Record last verified: 2026-07

Locations

CN (1)