Can a new siRNA injection keep high triglycerides in check for the long haul?
NCT ID NCT07799688
First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time
Summary
This Phase 2 trial tests the long-term safety and effectiveness of HRS-7249, an investigational injection that targets a protein called APOC3 to lower triglycerides. The study includes people who previously took part in an earlier HRS-7249 trial, plus new participants aged 18 to 79 with high fasting triglyceride levels. Over 48 weeks, participants receive repeated doses of HRS-7249, followed by a 24-week safety follow-up. Researchers monitor side effects, lipid levels, and markers of metabolic and cardiovascular health to see if the treatment remains safe and beneficial over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HRS-7249, an investigational GalNAc-conjugated APOC3-targeted siRNA injection
- What this could lead to
- If it works, this could lead to a long-term treatment that lowers triglycerides and may reduce the risk of pancreatitis and heart problems.
- What could go wrong
- This is an early-stage extension study, so long-term benefits and risks are not yet proven. Possible side effects include injection site reactions and other adverse events.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 79 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: \- Cohort 1 (Roll-over participants from HRS-7249-201) 1. Able to understand trial procedures, voluntarily participate and provide written informed consent; 2. Completed last visit of parent study HRS-7249-201 within 24 weeks prior to screening; 3. 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. Exclusion Criteria: \- Cohort 1 Exclusion 1. Permanently discontinued parent study treatment due to treatment-related adverse events (TRAE); 2. Persistent clinically significant adverse events or lab abnormalities unresolved by parent study final visit, judged by investigator to increase risk of continued dosing; 3. Unstable or severe hepatic, renal, cardiovascular, neurological, endocrine, hematologic disorders that render participation unacceptable; 4. Plan to receive major surgery during study period; 5. Planned plasmapheresis during trial; 6. Intend to use weight-loss drugs or undergo weight-altering surgery during trial; 7. Refuse lifestyle intervention or limit daily alcohol intake below 30 g/day; 8. Pregnant or breastfeeding females; 9. Fertile women without contraception within 30 days pre-screening; fertile male/female subjects refusing contraception and gamete donation restrictions through follow-up; 10. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030, China
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The First Affiliated Hospital of Shandong First Medical University (Qianfo Shan Hospital of shandong province).
Jinan, Shandong, 250014, China
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