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New treatment option for Hypertriglyceridemia
Official title A Study of SHR-1918 In Participants With Hypertriglyceridemia
ClinicalTrials.gov ID: NCT07349615
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male and female ≥ 18 years old, who is able and willing to provide a written informed consent.
- 1.7 ≤ TG ≤ 5.6 mmol/L.
- LDL-C \< 3.4 mmol/L.
- Male and female people of childbearing potential and their partners must have no plans to donate sperm or become pregnant during the entire study...
You likely can't join if
- History of severe allergies/hypersensitivity reactions, or clinically significant allergies/hypersensitivity reactions as judged by the investigator...
- Received or are currently receiving treatment with monoclonal antibodies, siRNA-based drugs, or ASO-based drugs targeting the same target prior to...
- Have a history of pancreatitis prior to screening or randomization.
- Acute ischemic ASCVD events within 3 months prior to screening or randomization.
- Heart failure with New York Heart Association (NYHA) Class III-IV prior to screening or randomization.
- Malignant tumors within 5 years.
See the full eligibility criteria
- Male and female ≥ 18 years old, who is able and willing to provide a written informed consent.
- 1.7 ≤ TG ≤ 5.6 mmol/L.
- LDL-C \< 3.4 mmol/L.
- Male and female people 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...
- 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.
- Received or are currently receiving treatment with monoclonal antibodies, siRNA-based drugs, or ASO-based drugs targeting the same target prior to screening.
- Have a history of pancreatitis prior to screening or randomization.
- Acute ischemic ASCVD events within 3 months prior to screening or randomization.
- Heart failure with New York Heart Association (NYHA) Class III-IV prior to screening or randomization.
- Malignant tumors within 5 years.
- 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.
- 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.
- Poorly controlled type 2 diabetes mellitus or previously diagnosed type 1 diabetes mellitus; poorly controlled hypertension.
- Have a history of major surgery within 3 months prior to screening, or plans to undergo major surgery during the study period.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.