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
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Fase
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
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
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)
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / 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
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
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
Sponsor
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- HRS-7249-203
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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