Severe Hypertriglyceridemia With a High Risk of Acute PancreatitisPhase 2NCT07308392

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

A Phase 2 study testing HRS-7249 injection set and SHR-1918 injection set in people with Severe Hypertriglyceridemia With a High Risk of Acute Pancreatitis, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

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 Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Severe Hypertriglyceridemia With a High Risk of Acute Pancreatitis
What is being tested?: HRS-7249 injection set and SHR-1918 injection set
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 119 participants
Where: 1 siteChina
Study dates: 25 Feb 2026to Jun 2027
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;
Acute coronary syndrome (such as myocardial infarction, unstable angina), history of coronary artery bypass grafting, percutaneous coronary intervention, peripheral artery revascularization, cerebrovascular diseases (such as stroke, transient ischemic attack), heart failure hospitalization, etc., within 3 months before screening or randomization;
Severe arrhythmias within 3 months before screening or randomization, such as recurrent symptomatic frequent ventricular premature beats, ventricular tachycardia, atrial fibrillation with rapid ventricular rate;

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Severe infection within 3 months before screening;
History or presence of nephrotic syndrome, severe liver disease, Cushing's syndrome, or other diseases significantly affecting lipid levels at screening;
History or presence of hyperthyroidism or hypothyroidism at screening;
Poorly controlled hypertension at screening or before randomization (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg);
Diabetes with any of the following: a. Newly diagnosed within 12 weeks before screening or randomization; b. HbA1c ≥8.0% at screening; c. Type 1 diabetes;
Unstable or severe liver, kidney, cardiovascular, psychiatric, neurological, endocrine, hematologic, or other diseases at screening or before randomization, where the investigator determines participation poses an unacceptable risk to the subject;
Serious trauma or major surgery within 6 months before screening, or planning major surgery during the trial;
Plasma exchange therapy within 4 weeks before screening or randomization, or planned during the trial;
Use of other drugs significantly affecting lipid levels within 4 weeks before screening or randomization, or planned during the trial, such as traditional Chinese medicine containing statins (e.g., Zhibituo, Zhibitai), other lipid-lowering drugs and supplements (e.g., probucol, bile acid sequestrants, niacin, over-the-counter drugs, red yeast rice), GLP-1 agonists, other incretin analogues;
Use of weight-loss drugs or undergoing weight-altering surgery within 2 months before screening or randomization, or planned during the study;
History of drug abuse or alcohol abuse (including heavy drinking [average ethanol intake >80 g/day], previously diagnosed alcohol harmful use, alcohol dependence, alcohol poisoning, alcohol withdrawal, alcohol-related disorder, or alcohol-induced psychiatric or behavioral disorder);
Significant lifestyle changes within 4 weeks before screening or randomization, or refusal to follow lifestyle guidance or limit alcohol intake to <30 g/day during the study;
eGFR calculated by the Modification of Diet in Renal Disease (MDRD) formula <60 mL/min/1.73 m²;
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 times the upper limit of normal (ULN);
Total bilirubin or direct bilirubin ≥2 times ULN;
Creatine kinase (CK) >1.5 times ULN;
Platelet count <100 x 10⁹/L (or history of thrombocytopenia);
Hemoglobin <60 g/L;
Confirmed active syphilis, positive test result for human immunodeficiency virus antibody (HIV-Ab) or hepatitis C virus antibody (HCV-Ab), positive hepatitis B surface antigen (HBsAg) with HBV-DNA ≥1000 copies/ml (or ≥200 IU/ml, or if the detection lower limit is higher than 1000 copies/ml or 200 IU/ml, HBV-DNA ≥ detection lower limit);
Thyroid-stimulating hormone (TSH) below the lower limit of normal (LLN) or above 1.5 times ULN;
Participation in any interventional drug clinical trial within 3 months prior to screening (participation is defined as administration of the investigational product to the subject), or still within 5 half-lives of the investigational product before screening, whichever is longer; previous participation in non-interventional clinical trials or device-related clinical trials may be judged by the investigator for inclusion;
Pregnant or breastfeeding women;
Women of childbearing potential who have not used contraception within 30 days prior to screening; women of childbearing potential and male subjects with partners of childbearing age who refuse to avoid donating sperm/eggs from the time of signing the informed consent until the end of the follow-up period, or refuse to comply with relevant contraceptive requirements;
Other conditions deemed by the investigator to make the subject unsuitable for participation in the trial.

Trial locations and contacts

1 site in 1 country.

China1 site

The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
Nanjing, Jiangsu, 210029

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled 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.

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

Conditions: Severe Hypertriglyceridemia With a High Risk of Acute Pancreatitis
Being tested: HRS-7249 injection set, SHR-1918 injection set, HRS-7249 injection placebo set, SHR-1918 injection placebo set

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HRS-7249 injection setDrug
HRS-7249 injection set
SHR-1918 injection setDrug
SHR-1918 injection set
HRS-7249 injection placebo setDrug
HRS-7249 injection placebo set
SHR-1918 injection placebo setDrug
SHR-1918 injection placebo set

Study groups in NCT07308392
Study group	Role	What they receive
HRS-7249 injection	Experimental	Not described Receives: Drug: HRS-7249 injection set
HRS-7249 injection placebo	Placebo comparator	Not described Receives: Drug: HRS-7249 injection placebo set
SHR-1918 injection	Experimental	Not described Receives: Drug: SHR-1918 injection set
SHR-1918 injection placebo	Placebo comparator	Not described Receives: Drug: SHR-1918 injection placebo set

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage change in mean TG from baseline at weeks 44 and 48 of treatment
Measured: at 44＆48 weeks after the start of administration
Proportion of subjects experiencing AP during the double-blind treatment period
Measured: within 48 weeks after the start of administration

Secondary outcomes (2)

During the double-blind treatment period, the time and severity of the first occurrence of AP
Measured: 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
Measured: within 48 weeks after the start of administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Feb 2026Jun 2027

First posted29 Dec 2025
Study start25 Feb 2026
Primary completionJun 2027 (estimated)
Study completionJun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Severe Hypertriglyceridemia With a High Risk of Acute PancreatitisStudies of the same condition, open and under way.
More trials run by Fujian Shengdi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 119 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07308392
Sponsor's protocol ID: HRS-7249-202
Status last verified: Nov 2025
First submitted: 15 Dec 2025
Last updated: 8 Sep 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Study at a glance

From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled 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.
ClinicalTrials.gov ID: NCT07308392
Acronym / sponsor ID: HRS-7249-202
Conditions: Severe Hypertriglyceridemia With a High Risk of Acute Pancreatitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 119 participants (actual)
Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 25 Feb 2026 (actual)
Primary completion: Jun 2027 (estimated)
Study completion: Jun 2027 (estimated)
First posted: 29 Dec 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
HRS-7249 injection	Experimental	Drug: HRS-7249 injection set
HRS-7249 injection placebo	Placebo comparator	Drug: HRS-7249 injection placebo set
SHR-1918 injection	Experimental	Drug: SHR-1918 injection set
SHR-1918 injection placebo	Placebo comparator	Drug: SHR-1918 injection placebo set

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (30 listed)

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;
Acute coronary syndrome (such as myocardial infarction, unstable angina), history of coronary artery bypass grafting, percutaneous coronary intervention, peripheral artery revascularization, cerebrovascular diseases (such as stroke, transient ischemic attack), heart failure hospitalization, etc., within 3 months before screening or randomization;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HRS-7249 injection setHRS-7249 injection set	Drug	HRS-7249 injection
SHR-1918 injection setSHR-1918 injection set	Drug	SHR-1918 injection
HRS-7249 injection placebo setHRS-7249 injection placebo set	Drug	HRS-7249 injection placebo
SHR-1918 injection placebo setSHR-1918 injection placebo set	Drug	SHR-1918 injection placebo

Primary outcome

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
Proportion of subjects experiencing AP during the double-blind treatment period
Time frame: within 48 weeks after the start of administration

2 secondary outcomes

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
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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
Individual participant dataSharing planned: Undecided

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07308392.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.