SHR - 1209 Treatment Efficacy and Safety of the Patients With Hypercholesterolemia Ⅲ Period Clinical Research

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-14

Study Completion Date

2022-08-12

Brief Summary

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This study is ongoing to evaluate the efficacy and safety of SHR-1209 in patients with hypercholesterolemia.

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Detailed Description

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Conditions

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Primary Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Background Lipolowering therapy in combination with SHR-1209/ placebo

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SHR-1209

Group Type EXPERIMENTAL

SHR-1209

Intervention Type DRUG

SHR-1209

SHR-1209 Placebo

Group Type PLACEBO_COMPARATOR

SHR-1209 Placebo

Intervention Type DRUG

SHR-1209 Placebo

Interventions

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SHR-1209

Intervention Type DRUG

SHR-1209 Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Any male or female aged between 18 and 80 on the date of signing the informed consent;
2. Diagnosed as hypercholesterolemia ;
3. Fasting triglyceride was less than 5.6 mmol/L during screening:
4. Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent.

Exclusion Criteria

1. A history of the following diseases or treatments during the screening period:

1. Known allergies to PCSK9 inhibitors or test drugs, or severe allergic reactions to other antibody drugs in the past;
2. Participated in clinical studies of other drug interventions within the last 1 month (except for patients who failed in screening), or those who are within 5 half-lives of the drug before screening (whichever is longer);
2. Any of the laboratory test indicators meets the following criteria:

1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) was more than 3 times the upper limit of normal value (ULN), and total bilirubin was more than 2 times ULN during the screening period or at random;
2. The creatine kinase (CK) was more than 3 times of ULN during the screening period or at random;
3. Have used the following drugs:

1. PCSK9 inhibitors had been used in the previous 6 months;
2. Continuous systemic corticosteroid therapy with doses exceeding or equivalent to 10mg of prednisone (oral or intravenous) within the previous 3 months was screened.
4. Other circumstances:

1. Women of reproductive age who are fertile but did not use contraception within 4 weeks before the screening period;Women who are pregnant or breastfeeding;Not agreed during the trial or at 24 weeks after the last dose
2. Subjects who are considered by the investigator to have any unsuitable factors for participating in the study or who have poor compliance.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No