What is SHR-1918 studying for hypertriglyceridemia?

SHR-1918 is being studied to evaluate its effects on lowering high triglyceride levels in people with hypertriglyceridemia. The trial compares SHR-1918 to a placebo to assess its safety and how well it works. This research is sponsored by Beijing Suncadia Pharmaceuticals Co., Ltd and is designed to find better treatment options.

Who may be eligible for this hypertriglyceridemia clinical trial?

Adults aged 18 years or older with triglyceride levels between 1.7 and 5.6 mmol/L and LDL cholesterol less than 3.4 mmol/L may be eligible. Both men and women can participate, but those of childbearing potential must agree to use contraception during the study. Please review eligibility criteria for more details.

Is there any cost to participate in this hypertriglyceridemia clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses to and from the study site may vary and are not guaranteed to be reimbursed.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID07349615

Phase III Study to Evaluate the Safety and Effectiveness of SHR-1918 for Treating Adults with High Blood Triglycerides

Led by Beijing Suncadia Pharmaceuticals Co., Ltd · Updated on 2026-06-16

360

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the effects of SHR-1918 in adults with hypertriglyceridemia, a condition characterized by high levels of triglycerides in the blood. This Phase III clinical trial aims to assess both the efficacy and safety of SHR-1918 compared to a placebo. The study is randomized, double-blind, and placebo-controlled to ensure reliable results. The lead sponsor for this research is Beijing Suncadia Pharmaceuticals Co., Ltd. Participants will receive subcutaneous injections of SHR-1918 or a placebo in two different doses. The treatment will last for up to 48 weeks, with evaluations at 24 and 48 weeks to measure changes in serum triglyceride levels and other lipid markers. The study has two experimental groups receiving different doses of SHR-1918 or placebo, and participants are randomly assigned to these groups. During the study, participants will undergo regular assessments including blood tests to monitor triglycerides, LDL cholesterol, HDL cholesterol, and other lipid-related measures. Researchers will also track the proportion of participants reaching target triglyceride levels and monitor any adverse events or injection site reactions. The primary outcome is the percentage change in triglyceride levels at weeks 20 and 24. The total participation duration may last about one year, including safety monitoring and follow-up evaluations.

CONDITIONS

Brief Title

A Study of SHR-1918 In Participants With Hypertriglyceridemia

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Male and female participants aged 18 years or older who can provide written informed consent
Serum triglyceride levels between 1.7 and 5.6 mmol/L
LDL cholesterol less than 3.4 mmol/L
Participants of childbearing potential and their partners must agree to use contraceptive methods during the study and after the last dose

You will not qualify if you...

History of severe or clinically significant allergies or hypersensitivity reactions, including to drugs with similar chemical structures
Current or previous treatment with monoclonal antibodies, siRNA-based drugs, or antisense oligonucleotide-based drugs targeting the same treatment before screening
History of pancreatitis before screening or randomization
Acute ischemic atherosclerotic cardiovascular disease events within 3 months prior to screening or randomization
Heart failure classified as New York Heart Association Class III-IV before screening or randomization
Malignant tumors diagnosed within the past 5 years
Plasma exchange therapy received within 2 months before screening, planned during the study, or previous LDL receptor gene therapy
Diseases significantly affecting blood lipid levels such as nephrotic syndrome, severe liver diseases, Cushing's syndrome, or severe arrhythmia before screening or randomization
Poorly controlled type 2 diabetes or diagnosed type 1 diabetes; poorly controlled hypertension
History of major surgery within 3 months before screening or planned major surgery during the study period

Research Team

Miaomiao Shi

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