NCT04849000

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
709

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 19, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

April 23, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2023

Completed
Last Updated

May 19, 2023

Status Verified

June 1, 2022

Enrollment Period

1.2 years

First QC Date

March 31, 2021

Last Update Submit

May 18, 2023

Conditions

Primary HypercholesterolemiaMixed Hyperlipemia

Outcome Measures

Primary Outcomes (1)

  • 12-weeks or 16weeks Percentage change in LDL-C relative to baseline

    12-weeks or 16weeks

Secondary Outcomes (2)

  • 12-weeks or 16weeks change in LDL-C relative to baseline；

    12-weeks or 16weeks

  • Percentage of changes in non-HDL-C, ApoB, TC/HDL-C, ApoB/ApoA1, LP (a) and TG relative to baseline and relative to baseline after 12 weeks or 16 weeks of treatment

    12 weeks or 16 weeks

Study Arms (2)

SHR-1209

EXPERIMENTAL
Drug: SHR-1209

SHR-1209 Placebo

PLACEBO COMPARATOR
Drug: SHR-1209 Placebo

Interventions

SHR-1209DRUG

SHR-1209

SHR-1209
SHR-1209 PlaceboDRUG

SHR-1209 Placebo

SHR-1209 Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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;
  • 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);
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangzhou, 510120, China

Location

Related Publications (1)

  • Shu C, Wang Y, Feng S, Yang S, Shen K. Population Pharmacokinetics and Pharmacodynamics Modeling for the Use of Recaticimab in Healthy Volunteers and Patients with Hypercholesterolemia. Clin Pharmacokinet. 2025 Sep;64(9):1341-1355. doi: 10.1007/s40262-025-01512-5. Epub 2025 Jun 30.

    PMID: 40587053DERIVED

MeSH Terms

Conditions

Hyperlipoproteinemia Type V

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHypertriglyceridemia

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: SHR-1209 monotherapy
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2021

First Posted

April 19, 2021

Study Start

April 23, 2021

Primary Completion

June 21, 2022

Study Completion

January 13, 2023

Last Updated

May 19, 2023

Record last verified: 2022-06

Locations

CN(1)