HyperlipidemiaPhase 2NCT07799688
A Extension Study to Evaluate the Safety and Efficacy of HRS-7249 in Patients With Hypertriglyceridemia
A Phase 2 study testing HRS-7249 Injection in people with Hyperlipidemia, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
This is a Phase II multi-center, open-label extension (OLE) clinical trial of HRS-7249, a GalNAc-conjugated APOC3-targeted siRNA injection, enrolling two cohorts of participants. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- HRS-7249 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesChina
- Study dates
- 11 Sep 2026to 15 Oct 2028
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cohort 1 (Roll-over participants from HRS-7249-201)
- Able to understand trial procedures, voluntarily participate and provide written informed consent;
- Completed last visit of parent study HRS-7249-201 within 24 weeks prior to screening;
- Male or female subjects aged ≥18 and <80 years at consent signature. Cohort 2 (Newly enrolled participants)
- 1. Able to understand trial procedures, voluntarily participate and provide written informed consent; 2. Fasting triglyceride ≥2.3 mmol/L at screening; 3. Male or female subjects aged ≥18 and <80 years at consent signature.
Who cannot join
- Cohort 1 Exclusion
- Permanently discontinued parent study treatment due to treatment-related adverse events (TRAE);
- Persistent clinically significant adverse events or lab abnormalities unresolved by parent study final visit, judged by investigator to increase risk of continued dosing;
- Unstable or severe hepatic, renal, cardiovascular, neurological, endocrine, hematologic disorders that render participation unacceptable;
- Plan to receive major surgery during study period;
- Planned plasmapheresis during trial;
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- Intend to use weight-loss drugs or undergo weight-altering surgery during trial;
- Refuse lifestyle intervention or limit daily alcohol intake below 30 g/day;
- Pregnant or breastfeeding females;
- Fertile women without contraception within 30 days pre-screening; fertile male/female subjects refusing contraception and gamete donation restrictions through follow-up;
- Any other conditions judged unsuitable by investigator. Cohort 2 Exclusion
- 1. History of acute pancreatitis within 3 months pre-randomization; 2. Plasmapheresis received or planned within 4 weeks pre-randomization; 3. Malignancy diagnosed within past 5 years (except cured non-melanoma skin cancer/cervical carcinoma in situ); 4. NYHA Class III/IV heart failure at screening/randomization; 5. Acute coronary syndrome, stroke, TIA, major cardiovascular revascularization within past 3 months; 6. Severe symptomatic arrhythmia within 3 months pre-randomization; 7. Severe trauma/major surgery within 6 months or planned major operation during trial; 8. Severe infection within past 3 months; 9. Nephrotic syndrome, severe liver disease, Cushing syndrome interfering with lipid metabolism; 10. Unstable severe multi-organ systemic diseases; 11. Uncontrolled hypertension (SBP≥160 mmHg or DBP≥100 mmHg); 12. Plan to take weight-loss agents or bariatric surgery within 2 months pre-screening; 13. Type 1 DM, newly diagnosed DM within 12 weeks, or HbA1c ≥8.5%; 14. Current/history hyper/hypothyroidism; 15. History of substance/alcohol abuse (daily ethanol >80 g); 16. Major lifestyle modification within past 4 weeks or refusal of alcohol/lifestyle limits; 17. eGFR <60 mL/min/1.73m² by MDRD formula; 18. ALT/AST ≥2×ULN; 19. Total/direct bilirubin ≥1.5×ULN; 20. CK >1.5×ULN; 21. Platelet count <100×10⁹/L or thrombocytopenia history; 22. Positive HIV/HCV-Ab, or HBsAg positive with HBV-DNA ≥1000 copies/mL; 23. Participated in other interventional drug trials within 3 months pre-screening; 24. Pregnant or lactating women; 25. Fertile subjects without compliant contraception; 26. Any other conditions deemed inappropriate by investigator.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The First Affiliated Hospital of Shandong First Medical University (Qianfo Shan Hospital of shandong province).
Jinan, Shandong, 250014
Mei Gao
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Xumin Hou
About this study
Official title: A Multi-center, Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of HRS-7249 in Patients With Hypertriglyceridemia
This is a Phase II multi-center, open-label extension (OLE) clinical trial of HRS-7249, a GalNAc-conjugated APOC3-targeted siRNA injection, enrolling two cohorts of participants. Cohort 1 includes subjects who completed parent study HRS-7249-201 within 24 weeks; Cohort 2 newly recruited patients with fasting triglyceride (TG) ≥2.3 mmol/L aged 18-79 years. All participants receive subcutaneous HRS-7249 for a 48-week treatment period followed by a 24-week safety follow-up phase, with two dosing regimens. The primary objective is to assess long-term safety and tolerability of repeated HRS-7249 administration. Secondary objectives include evaluating sustained lipid-lowering effects on TG, APOC3 and other lipid profiles, impacts on glycometabolism, incidence of acute pancreatitis and major adverse cardiovascular events (MACE), long-term pharmacokinetic/pharmacodynamic (PK/PD) profiles, and anti-drug antibody (ADA) dynamics. All safety assessments including vital signs, physical examinations, laboratory tests, 12-lead ECG, injection site reactions and adverse events will be collected throughout the study. Lipid parameters, HbA1c, pancreatitis and cardiovascular events will be monitored to characterize the clinical benefit-risk profile of long-term HRS-7249 therapy in hypertriglyceridemia patients. A total of at least 400 subjects will be enrolled nationwide in China.
- Conditions
- Hyperlipidemia
- Being tested
- HRS-7249 Injection
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-7249 InjectionDrug
Dosing level: Low dose
HRS-7249 InjectionDrug
Dosing level: High dose
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | HRS-7249 Injection; Low dose, subcutaneous administration Receives: Drug: HRS-7249 Injection |
| Arm 2 | Experimental | HRS-7249 Injection; High dose, subcutaneous administration Receives: Drug: HRS-7249 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Injection site reactions
Measured: 48 weeks
All adverse events (AEs)
Measured: 72 weeks
Respiratory rate
Measured: 72 weeks
Pulse rate
Measured: 72 weeks
Systolic and diastolic blood pressure
Measured: 72 weeks
Body temperature
Measured: 72 weeks
Complete Blood Count
Measured: 72 weeks
Blood chemistry
Measured: 72 weeks
High-sensitivity C-reactive protein (hs-CRP)
Measured: 72 weeks；
Heart rate
Measured: 72 weeks；
PR interval
Measured: 72 weeks
QRS duration
Measured: 72 weeks
QT interval
Measured: 72 weeks
QTc interval
Measured: 72 weeks
Urinalysis
Measured: 72 weeks
Secondary outcomes (20)
Proportion of patients with TG<1.7 mmol/L
Measured: 48 weeks
Proportion of patients with TG<2.3 mmol/L
Measured: 48 weeks
Proportion of patients with baseline TG≥5.7 mmol/L achieving TG<5.7 mmol/L
Measured: 48 weeks
Percentage change and absolute value change from baseline in TG
Measured: 72 weeks
Percentage change and absolute value change from baseline in APOC3
Measured: 72 weeks
Percentage change and absolute value change from baseline in HDL-C
Measured: 72 weeks
Percentage change and absolute value change from baseline in TC
Measured: 72 weeks
Percentage change and absolute value change from baseline in LDL-C
Measured: 72 weeks
Percentage change and absolute value change from baseline in sdLDL-C
Measured: 72 weeks
Percentage change and absolute value change from baseline in non-HDL-C
Measured: 72 weeks
Percentage change and absolute value change from baseline in ApoB
Measured: 72 weeks
Percentage change and absolute value change from baseline in ApoA1
Measured: 72 weeks
Percentage change and absolute value change from baseline in Lp(a)
Measured: 72 weeks
Percentage change and absolute value change from baseline in VLDL-C
Measured: 72 weeks
Percentage change and absolute value change from baseline in RC
Measured: 72 weeks
Percentage change and absolute value change from baseline in HbA1c
Measured: 72 weeks
Incidence rate of acute pancreatitis
Measured: 72 weeks
Incidence rate of major adverse cardiovascular events (MACE, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for unstable angina, or coronary revascularization)
Measured: 72 weeks
Plasma Concentration of long-term HRS-7249 treatment
Measured: 72 weeks
Dynamics of anti-drug antibody (ADA) following long-term HRS-7249 treatment
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start11 Sep 2026
- Primary completion15 Oct 2028 (estimated)
- Study completion15 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799688
- Sponsor's protocol ID
- HRS-7249-203
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 9 Oct 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of HRS-7249 in Patients With Hypertriglyceridemia
- ClinicalTrials.gov ID
- NCT07799688
- Acronym / sponsor ID
- HRS-7249-203
- Conditions
- Hyperlipidemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Sep 2026 (actual)
- Primary completion
- 15 Oct 2028 (estimated)
- Study completion
- 15 Oct 2028 (estimated)
- First posted
- 2 Sep 2026 (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.
This is a Phase II multi-center, open-label extension (OLE) clinical trial of HRS-7249, a GalNAc-conjugated APOC3-targeted siRNA injection, enrolling two cohorts of participants. Cohort 1 includes subjects who completed parent study HRS-7249-201 within 24 weeks; Cohort 2 newly recruited patients with fasting triglyceride (TG) ≥2.3 mmol/L aged 18-79 years. All participants receive subcutaneous HRS-7249 for a 48-week treatment period followed by a 24-week safety follow-up phase, with two dosing regimens. The primary objective is to assess long-term safety and tolerability of repeated HRS-7249 administration. Secondary objectives include evaluating sustained lipid-lowering effects on TG, APOC3 and other lipid profiles, impacts on glycometabolism, incidence of acute pancreatitis and major adverse cardiovascular events (MACE), long-term pharmacokinetic/pharmacodynamic (PK/PD) profiles, and anti-drug antibody (ADA) dynamics. All safety assessments including vital signs, physical examinations, laboratory tests, 12-lead ECG, injection site reactions and adverse events will be collected throughout the study. Lipid parameters, HbA1c, pancreatitis and cardiovascular events will be monitored to characterize the clinical benefit-risk profile of long-term HRS-7249 therapy in hypertriglyceridemia patients. A total of at least 400 subjects will be enrolled nationwide in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: HRS-7249 InjectionHRS-7249 Injection; Low dose, subcutaneous administration |
| Arm 2 | Experimental | Drug: HRS-7249 InjectionHRS-7249 Injection; High dose, subcutaneous administration |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Cohort 1 (Roll-over participants from HRS-7249-201)
- Able to understand trial procedures, voluntarily participate and provide written informed consent;
- Completed last visit of parent study HRS-7249-201 within 24 weeks prior to screening;
- Male or female subjects aged ≥18 and <80 years at consent signature. Cohort 2 (Newly enrolled participants)
- 1. Able to understand trial procedures, voluntarily participate and provide written informed consent; 2. Fasting triglyceride ≥2.3 mmol/L at screening; 3. Male or female subjects aged ≥18 and <80 years at consent signature.
Key exclusion criteria (12 listed)
- Cohort 1 Exclusion
- Permanently discontinued parent study treatment due to treatment-related adverse events (TRAE);
- Persistent clinically significant adverse events or lab abnormalities unresolved by parent study final visit, judged by investigator to increase risk of continued dosing;
- Unstable or severe hepatic, renal, cardiovascular, neurological, endocrine, hematologic disorders that render participation unacceptable;
- Plan to receive major surgery during study period;
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 InjectionDosing level: Low dose | Drug | Arm 1 |
| HRS-7249 InjectionDosing level: High dose | Drug | Arm 2 |
Primary outcome
Injection site reactions
Time frame: 48 weeks
All adverse events (AEs)
Time frame: 72 weeks
Respiratory rate
Time frame: 72 weeks
Pulse rate
Time frame: 72 weeks
Systolic and diastolic blood pressure
Time frame: 72 weeks
Body temperature
Time frame: 72 weeks
Complete Blood Count
Time frame: 72 weeks
Blood chemistry
Time frame: 72 weeks
High-sensitivity C-reactive protein (hs-CRP)
Time frame: 72 weeks；
Heart rate
Time frame: 72 weeks；
PR interval
Time frame: 72 weeks
QRS duration
Time frame: 72 weeks
QT interval
Time frame: 72 weeks
QTc interval
Time frame: 72 weeks
Urinalysis
Time frame: 72 weeks
20 secondary outcomes
Proportion of patients with TG<1.7 mmol/L
Time frame: 48 weeks
Proportion of patients with TG<2.3 mmol/L
Time frame: 48 weeks
Proportion of patients with baseline TG≥5.7 mmol/L achieving TG<5.7 mmol/L
Time frame: 48 weeks
Percentage change and absolute value change from baseline in TG
Time frame: 72 weeks
Percentage change and absolute value change from baseline in APOC3
Time frame: 72 weeks
Percentage change and absolute value change from baseline in HDL-C
Time frame: 72 weeks
Percentage change and absolute value change from baseline in TC
Time frame: 72 weeks
Percentage change and absolute value change from baseline in LDL-C
Time frame: 72 weeks
Percentage change and absolute value change from baseline in sdLDL-C
Time frame: 72 weeks
Percentage change and absolute value change from baseline in non-HDL-C
Time frame: 72 weeks
Percentage change and absolute value change from baseline in ApoB
Time frame: 72 weeks
Percentage change and absolute value change from baseline in ApoA1
Time frame: 72 weeks
Percentage change and absolute value change from baseline in Lp(a)
Time frame: 72 weeks
Percentage change and absolute value change from baseline in VLDL-C
Time frame: 72 weeks
Percentage change and absolute value change from baseline in RC
Time frame: 72 weeks
Percentage change and absolute value change from baseline in HbA1c
Time frame: 72 weeks
Incidence rate of acute pancreatitis
Time frame: 72 weeks
Incidence rate of major adverse cardiovascular events (MACE, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for unstable angina, or coronary revascularization)
Time frame: 72 weeks
Plasma Concentration of long-term HRS-7249 treatment
Time frame: 72 weeks
Dynamics of anti-drug antibody (ADA) following long-term HRS-7249 treatment
Time frame: 72 weeks
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 9 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRS-7249 Injection in people with Hyperlipidemia, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 2 sites in China.
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 5 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Contact Chanjuan Deng, MM (0518-82342973, Chanjuan.deng@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Injection site reactions (time frame: 48 weeks). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2026; AzTrials last refreshed its copy on 1 Nov 2026.