Clinical trial NCT04844125: SHR - 1209 Treatment Efficacy and Safety of the Patients With Hypercholesterolemia Ⅲ Period Clinical Research
Official title: A Multicentric, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of SHR-1209 in Patients With Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Hypercholesterolemia
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-04-14
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Background Lipolowering therapy in combination with SHR-1209/ placebo
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: 12 weeks Percentage change in serum LDL-C levels from baseline.
timeFrame: 12 weeks
Secondary outcomes:
measure: 12 weeks Absolute Changes in serum LDL-C levels from baseline；
timeFrame: 12 weeks
measure: 12 weeks Percentage change of non-HDL-C relative to baseline；
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangzhou
Study officials:
References: