Study of SHR-1209 in the Treatment of Hypercholesterolemia and Hyperlipidemia Ⅲ Stage

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

709 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-23

Study Completion Date

2023-01-13

Brief Summary

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

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Detailed Description

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Conditions

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Primary Hypercholesterolemia Mixed Hyperlipemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

SHR-1209 monotherapy

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. Age ≥18 and ≤80 on the date of signing the informed consent, male or female;
2. Fasting LDL-C was ≥2.6mmol/L and \<4.9mmol/L at screening and randomization；
3. Those who understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent in person.

Exclusion Criteria

1. Have the following diseases or treatment history :(1) Have known allergic reaction to experimental drugs, or have severe allergic reaction to other antibody drugs;(2) previous diagnosis of cardiac function as defined by the New York Heart Association (NYHA) grade III-IV;
2. Any of the laboratory indicators met the following criteria at screening or at random :(1) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 2 times the upper limit of normal (ULN), or total bilirubin exceeding 1.5 times the upper limit of normal (ULN);(2) Creatine kinase (CK) exceeds 3 times the upper limit of normal value (ULN);
3. General conditions :(1) the investigator judged that subcutaneous injection was not appropriate;(2) Fertile female subjects who did not use contraception within 4 weeks before screening;Or male or female subjects who do not agree to use high-efficiency contraceptives during the trial and for 24 weeks after the last dosing;(3) Women who are pregnant or lactating.
4. The Investigator determines that the subjects have poor compliance or have any factors that may prevent them from participating in the study, including, but not limited to, the study placing the subjects at unacceptable risk or possibly interfering with the study results.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No