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Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemia

NCT ID: NCT06471218

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-02

Study Completion Date

2025-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment A:SHR-1918/SHR-1918 Placebo

Group Type EXPERIMENTAL

SHR-1918; SHR-1918 Placebo

Intervention Type DRUG

SHR-1918/SHR-1918 Placebo,two administration

Treatment B:SHR-1918/SHR-1918 Placebo

Group Type EXPERIMENTAL

SHR-1918; SHR-1918 Placebo

Intervention Type DRUG

SHR-1918/SHR-1918 Placebo,two administration

Interventions

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SHR-1918; SHR-1918 Placebo

SHR-1918/SHR-1918 Placebo,two administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 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;
2. Screen spatiotemporal abdominal LDL-C for ASCVD risk assessment, meeting the following conditions:
3. TG≤5.6mmol/L；

Exclusion Criteria

1. (1) Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or gamma glutamyltransferase (GGT) exceeding 3 times the ULN, or total bilirubin exceeding 2 times the ULN;
2. (2) 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 ≥ 200IU/ml, if the lower limit of the detection value is higher than 1000 copies/ml or 200IU/ml, HBV-DNA ≥ the lower limit of the detection value);
3. (3) Creatine kinase (CK) exceeds 3 times the upper limit of normal value (ULN);
4. (4) Thyroid stimulating hormone (TSH) is below the lower limit of normal (LLN) or exceeds 1.5 times the upper limit of normal (ULN);
5. (5) 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);
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Suncadia Pharmaceuticals Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Meizhou People's Hospital

Meizhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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SHR-1918-203

Identifier Type: -

Identifier Source: org_study_id