Health TrialsbyHealthPanel

A Study of SHR-1918 In Participants With Hypertriglyceridemia

ConditionHypertriglyceridemia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Suncadia Pharmaceuticals Co., Ltd

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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 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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHR-1918/ SHR-1918 placebo

    Drug

    SHR-1918/ SHR-1918 placebo Dose 1

  • SHR-1918/ SHR-1918 placebo

    Drug

    SHR-1918/ SHR-1918 placebo Dose 2

Treatment groups

360 Participants
are divided into 2 treatment groups
Group A: SHR-1918/ SHR-1918 placebo Group A , subcutaneous injection；Experimental treatment 1 intervention
Group B: SHR-1918/ SHR-1918 placebo Group B, subcutaneous injection；Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percentage change in mean serum triglyceride (TG) levels at Week 20 and Week 24 relative to baseline

Time frame
at 20 weeks and 24 weeks of treatment

Secondary outcomes

1

Percentage change in non-HDL-C relative to baseline

Time frame
at 24 weeks of treatment
2

Percentage change in LDL-C relative to baseline

Time frame
at 24 weeks of treatment
3

Percentage change in TC relative to baseline

Time frame
at 24 weeks of treatment
4

Percentage change in ApoB relative to baseline

Time frame
at 24 weeks of treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Suncadia Pharmaceuticals Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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