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Phase II Clinical Trial Evaluating the Efficacy and Safety of HRS-7249 and SHR-1918 in Patients With Severe Hypertriglyceridemia at High Risk of Acute Pancreatitis

ConditionSevere Hypertriglyceridemia With a High Risk of Acute Pancreatitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFujian Shengdi Pharmaceutical Co., Ltd.

About this trial

Phase II clinical trial evaluating the efficacy and safety of HRS-7249 and SHR-1918 in patients with severe hypertriglyceridemia at high risk of acute pancreatitis

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Understand the research procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing;

Male or female aged ≥18 years and <80 years on the day of signing the informed consent form.

Disqualifiers

History of gallstones at the time of screening or previously (except for patients who had their gallbladder removed more than 3 months ago);

Acute pancreatitis that has clinically recovered ≤4 weeks before screening or randomization;

Malignant tumor within 5 years before screening or randomization (except for non-melanoma skin cancer or cervical carcinoma in situ that has been radically treated);

Grade 3/4 heart failure at the time of screening or before randomization;

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRS-7249 injection set

    Drug

    HRS-7249 injection set

  • SHR-1918 injection set

    Drug

    SHR-1918 injection set

  • HRS-7249 injection placebo set

    Drug

    HRS-7249 injection placebo set

  • SHR-1918 injection placebo set

    Drug

    SHR-1918 injection placebo set

Treatment groups

108 Participants
are divided into 4 treatment groups
Group A: HRS-7249 injectionExperimental treatment 1 intervention
Group B: HRS-7249 injection placeboPlacebo comparator 1 intervention
Group C: SHR-1918 injectionExperimental treatment 1 intervention
Group D: SHR-1918 injection placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage change in mean TG from baseline at weeks 44 and 48 of treatment

Time frame
at 44＆48 weeks after the start of administration
2

Proportion of subjects experiencing AP during the double-blind treatment period

Time frame
within 48 weeks after the start of administration

Secondary outcomes

1

During the double-blind treatment period, the time and severity of the first occurrence of AP

Time frame
within 48 weeks after the start of administration
2

During the double-blind treatment period, the proportion of subjects who developed HTG-AP, the time to first occurrence of HTG-AP, and its severity

Time frame
within 48 weeks after the start of administration

Other outcomes

Sponsors and contacts

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

Fujian Shengdi Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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