- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07799688
A Extension Study to Evaluate the Safety and Efficacy of HRS-7249 in Patients With Hypertriglyceridemia
A Multi-center, Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of HRS-7249 in Patients With Hypertriglyceridemia
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: Chanjuan Deng, MM
- Telefonnummer: 0518-82342973
- E-mail: Chanjuan.deng@hengrui.com
Undersøgelse Kontakt Backup
- Navn: Jianpeng Su, MS
- Telefonnummer: 0518-82342973
- E-mail: jianpeng.su.js18@hengrui.com
Studiesteder
-
-
Shandong
-
Jinan, Shandong, Kina, 250014
- The First Affiliated Hospital of Shandong First Medical University (Qianfo Shan Hospital of shandong province).
-
Ledende efterforsker:
- Mei Gao
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kina, 200030
- Shanghai Chest Hospital
-
Ledende efterforsker:
- Xumin Hou
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Arm 1
HRS-7249 Injection; Low dose, subcutaneous administration
|
Dosing level: Low dose
Dosing level: High dose
|
|
Eksperimentel: Arm 2
HRS-7249 Injection; High dose, subcutaneous administration
|
Dosing level: Low dose
Dosing level: High dose
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Injection site reactions
Tidsramme: 48 weeks
|
48 weeks
|
|
All adverse events (AEs)
Tidsramme: 72 weeks
|
72 weeks
|
|
Respiratory rate
Tidsramme: 72 weeks
|
72 weeks
|
|
Pulse rate
Tidsramme: 72 weeks
|
72 weeks
|
|
Systolic and diastolic blood pressure
Tidsramme: 72 weeks
|
72 weeks
|
|
Body temperature
Tidsramme: 72 weeks
|
72 weeks
|
|
Complete Blood Count
Tidsramme: 72 weeks
|
72 weeks
|
|
Blood chemistry
Tidsramme: 72 weeks
|
72 weeks
|
|
High-sensitivity C-reactive protein (hs-CRP)
Tidsramme: 72 weeks;
|
72 weeks;
|
|
Heart rate
Tidsramme: 72 weeks;
|
72 weeks;
|
|
PR interval
Tidsramme: 72 weeks
|
72 weeks
|
|
QRS duration
Tidsramme: 72 weeks
|
72 weeks
|
|
QT interval
Tidsramme: 72 weeks
|
72 weeks
|
|
QTc interval
Tidsramme: 72 weeks
|
72 weeks
|
|
Urinalysis
Tidsramme: 72 weeks
|
72 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Proportion of patients with TG<1.7 mmol/L
Tidsramme: 48 weeks
|
48 weeks
|
|
Proportion of patients with TG<2.3 mmol/L
Tidsramme: 48 weeks
|
48 weeks
|
|
Proportion of patients with baseline TG≥5.7 mmol/L achieving TG<5.7 mmol/L
Tidsramme: 48 weeks
|
48 weeks
|
|
Percentage change and absolute value change from baseline in TG
Tidsramme: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in APOC3
Tidsramme: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in HDL-C
Tidsramme: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in TC
Tidsramme: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in LDL-C
Tidsramme: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in sdLDL-C
Tidsramme: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in non-HDL-C
Tidsramme: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in ApoB
Tidsramme: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in ApoA1
Tidsramme: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in Lp(a)
Tidsramme: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in VLDL-C
Tidsramme: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in RC
Tidsramme: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in HbA1c
Tidsramme: 72 weeks
|
72 weeks
|
|
Incidence rate of acute pancreatitis
Tidsramme: 72 weeks
|
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)
Tidsramme: 72 weeks
|
72 weeks
|
|
Plasma Concentration of long-term HRS-7249 treatment
Tidsramme: 72 weeks
|
72 weeks
|
|
Dynamics of anti-drug antibody (ADA) following long-term HRS-7249 treatment
Tidsramme: 72 weeks
|
72 weeks
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HRS-7249-203
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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