Loading clinical trials...

A Study of SHR-1918 In Participants With Hypertriglyceridemia | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE3

A Study of SHR-1918 In Participants With Hypertriglyceridemia

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hypertriglyceridemia

NCT07349615•Beijing Suncadia Pharmaceuticals Co., Ltd

View on ClinicalTrials.gov

Summary

The purpose of the study is to evaluate the efficacy and safety of SHR-1918 in patients with hypertriglyceridemia. The efficacy and safety of SHR-1918 will be evaluated after 24-weeks and 48-weeks treatment.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male and female ≥ 18 years old, who is able and willing to provide a written informed consent.
•2. 1.7 ≤ TG ≤ 5.6 mmol/L.
•3. LDL-C \< 3.4 mmol/L.
•4. Male and female subjects of childbearing potential and their partners must have no plans to donate sperm or become pregnant during the entire study period and after the last dose, and agree to use contraceptive methods as specified in the protocol.

Exclusion Criteria

•1. History of severe allergies/hypersensitivity reactions, or clinically significant allergies/hypersensitivity reactions as judged by the investigator, or history of allergies to drugs with similar chemical structures.
•2. Received or are currently receiving treatment with monoclonal antibodies, siRNA-based drugs, or ASO-based drugs targeting the same target prior to screening.
•3. Have a history of pancreatitis prior to screening or randomization.
•4. Acute ischemic ASCVD events within 3 months prior to screening or randomization.
•5. Heart failure with New York Heart Association (NYHA) Class III-IV prior to screening or randomization.
•6. Malignant tumors within 5 years.
•7. Received plasma exchange therapy within 2 months prior to screening, or plans to receive plasma exchange therapy during the study period, or has received LDL receptor gene therapy prior to screening.
•8. Have a history of diseases that significantly affect blood lipid levels, such as nephrotic syndrome, severe liver diseases, Cushing's syndrome, or have severe arrhythmia prior to screening or randomization.
•9. Poorly controlled type 2 diabetes mellitus or previously diagnosed type 1 diabetes mellitus; poorly controlled hypertension.
•10. Have a history of major surgery within 3 months prior to screening, or plans to undergo major surgery during the study period.

Locations (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

February 1, 2026

Primary Completion Date

November 1, 2027

Completion Date

November 1, 2027

Last Updated

February 9, 2026

Enrollment

360

ESTIMATED participants

Conditions

Hypertriglyceridemia

Interventions

SHR-1918/ SHR-1918 placebo

DRUG

SHR-1918/ SHR-1918 placebo

DRUG

Contacts

Miaomiao Shi

CONTACT

18036617171 Miaomiao.shi@hengrui.com

Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia

NCT06822790

Hypertriglyceridemia

View study

COMPLETEDPHASE3

A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia

NCT05552326

Severe Hypertriglyceridemia

View study

COMPLETEDPHASE1

A VSA003 Phase 1 Study in Chinese Adult Healthy Volunteers

NCT05851066

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of SHR-1918 In Participants With Hypertriglyceridemia

Inclusion Criteria

Exclusion Criteria

Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia

A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia

A VSA003 Phase 1 Study in Chinese Adult Healthy Volunteers

Chia Seeds Consumption in Hypertriglyceridemia

Impacts of Aronia on Inflammation and the Gut Microbiome

The Effect of Omega-3 FA on Hypertriglyceridemia in Patients With T2DM(OCEAN)