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HRS-7249 set

Phase 2

Severe Hypertriglyceridemia With a High Risk of Acute Pancreatitis | Small molecule | Other |Co-Diagnostics, Inc.|Last Updated: Mar 3, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment108
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07308392Phase II Clinical Trial Evaluating the Efficacy and Safety of HRS-7249 and SHR-1918 in Patients With Severe Hypertriglyceridemia at High Risk of Acute PancreatitisPHASE2 RECRUITING 108 — — Feb 25, 2026Jun 1, 2027Mar 3, 20261 China
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Study Endpoints
Primary Endpoints
Percentage change in mean TG from baseline at weeks 44 and 48 of treatment
at 44＆48 weeks after the start of administration
Proportion of subjects experiencing AP during the double-blind treatment period
within 48 weeks after the start of administration
Secondary Endpoints
During the double-blind treatment period, the time and severity of the first occurrence of AP
within 48 weeks after the start of administration
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
within 48 weeks after the start of administration
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
HRS-7249 injectionEXPERIMENTAL -
HRS-7249 injection placeboPLACEBO_COMPARATOR -
SHR-1918 injectionEXPERIMENTAL -
SHR-1918 injection placeboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
HRS-7249 injection setDRUGHRS-7249 injection set
SHR-1918 injection setDRUGSHR-1918 injection set
HRS-7249 injection placebo setDRUGHRS-7249 injection placebo set
SHR-1918 injection placebo setDRUGSHR-1918 injection placebo set
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Understand the research procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing; 2. Male or female aged ≥18 years and \<80 years on the day of signing the informed consent form. Exclusion Criteria: 1. History of gallstone...

Countries:China
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07308392studyFirstPostDate: changed