Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemia

NCT06471218 | Completed Phase 2

• 1 other identifier: SHR-1918-203
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of the efficacy and safety of multiple subcutaneous injections of SHR-1918 in patients with hyperlipidemia in poor control: a multicenter, randomized, double-blind, placebo-controlled phase II clinical trials

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• Percent change in calculated LDL-C from baseline to week 24

  from baseline to week 24

Secondary Outcomes (1)

• Percent change in calculated TG from baseline to week 24

  from baseline to week 24

Study Arms (2)

Treatment A:SHR-1918/SHR-1918 Placebo

EXPERIMENTAL

Drug: SHR-1918; SHR-1918 Placebo

Treatment B:SHR-1918/SHR-1918 Placebo

EXPERIMENTAL

Drug: SHR-1918; SHR-1918 Placebo

Interventions

SHR-1918; SHR-1918 Placebo DRUG

SHR-1918/SHR-1918 Placebo,two administration

Treatment A:SHR-1918/SHR-1918 Placebo; Treatment B:SHR-1918/SHR-1918 Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• On the day of signing the informed consent form, the age must be ≥ 18 years old and ≤ 75 years old, both men and women are eligible;
• Screen spatiotemporal abdominal LDL-C for ASCVD risk assessment, meeting the relevant conditions;
• TG≤5.6mmol/L.

You may not qualify if:

• Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or gamma glutamyltransferase (GGT) exceeding 3 times the ULN, or total bilirubin exceeding 2 times the ULN;
• Human immunodeficiency virus antibody (HIV Ab), hepatitis C virus antibody (HCV Ab), any of the above test results are positive; Hepatitis B virus surface antigen (HBsAg) positive and HBV-DNA ≥ 1000 copies/ml (or ≥ 200 IU/ml, if the lower limit of the detection value is higher than 1000 copies/ml or 200 IU/ml, HBV-DNA ≥ the lower limit of the detection value);
• Creatine kinase (CK) exceeds 3 times the upper limit of normal value (ULN);
• Thyroid stimulating hormone (TSH) is below the lower limit of normal (LLN) or exceeds 1.5 times the upper limit of normal (ULN);
• Glomerular filtration rate (eGFR)\<30 ml/min/1.73m2 (calculated using the MDRD formula, eGFR (mL/min/1.73m2)=175 x (serum creatinine/88.4) -1.234 x age -0.179 x (0.79 females), where serum creatinine units are μ mol/L).

Sponsors & Collaborators

• Beijing Suncadia Pharmaceuticals Co., Ltd: lead

Study Sites (1)

Meizhou People's Hospital

Meizhou, Guangdong, 514031, China

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

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: June 18, 2024
• First Posted: June 24, 2024
• Study Start: July 2, 2024
• Primary Completion: May 16, 2025
• Study Completion: May 16, 2025
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

CN (1)