- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 2
Contatti e Sedi
Contatto studio
- Nome: Chanjuan Deng, MM
- Numero di telefono: 0518-82342973
- Email: Chanjuan.deng@hengrui.com
Backup dei contatti dello studio
- Nome: Jianpeng Su, MS
- Numero di telefono: 0518-82342973
- Email: jianpeng.su.js18@hengrui.com
Luoghi di studio
-
-
Shandong
-
Jinan, Shandong, Cina, 250014
- The First Affiliated Hospital of Shandong First Medical University (Qianfo Shan Hospital of shandong province).
-
Investigatore principale:
- Mei Gao
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Cina, 200030
- Shanghai Chest Hospital
-
Investigatore principale:
- Xumin Hou
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Arm 1
HRS-7249 Injection; Low dose, subcutaneous administration
|
Dosing level: Low dose
Dosing level: High dose
|
|
Sperimentale: Arm 2
HRS-7249 Injection; High dose, subcutaneous administration
|
Dosing level: Low dose
Dosing level: High dose
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Injection site reactions
Lasso di tempo: 48 weeks
|
48 weeks
|
|
All adverse events (AEs)
Lasso di tempo: 72 weeks
|
72 weeks
|
|
Respiratory rate
Lasso di tempo: 72 weeks
|
72 weeks
|
|
Pulse rate
Lasso di tempo: 72 weeks
|
72 weeks
|
|
Systolic and diastolic blood pressure
Lasso di tempo: 72 weeks
|
72 weeks
|
|
Body temperature
Lasso di tempo: 72 weeks
|
72 weeks
|
|
Complete Blood Count
Lasso di tempo: 72 weeks
|
72 weeks
|
|
Blood chemistry
Lasso di tempo: 72 weeks
|
72 weeks
|
|
High-sensitivity C-reactive protein (hs-CRP)
Lasso di tempo: 72 weeks;
|
72 weeks;
|
|
Heart rate
Lasso di tempo: 72 weeks;
|
72 weeks;
|
|
PR interval
Lasso di tempo: 72 weeks
|
72 weeks
|
|
QRS duration
Lasso di tempo: 72 weeks
|
72 weeks
|
|
QT interval
Lasso di tempo: 72 weeks
|
72 weeks
|
|
QTc interval
Lasso di tempo: 72 weeks
|
72 weeks
|
|
Urinalysis
Lasso di tempo: 72 weeks
|
72 weeks
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Proportion of patients with TG<1.7 mmol/L
Lasso di tempo: 48 weeks
|
48 weeks
|
|
Proportion of patients with TG<2.3 mmol/L
Lasso di tempo: 48 weeks
|
48 weeks
|
|
Proportion of patients with baseline TG≥5.7 mmol/L achieving TG<5.7 mmol/L
Lasso di tempo: 48 weeks
|
48 weeks
|
|
Percentage change and absolute value change from baseline in TG
Lasso di tempo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in APOC3
Lasso di tempo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in HDL-C
Lasso di tempo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in TC
Lasso di tempo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in LDL-C
Lasso di tempo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in sdLDL-C
Lasso di tempo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in non-HDL-C
Lasso di tempo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in ApoB
Lasso di tempo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in ApoA1
Lasso di tempo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in Lp(a)
Lasso di tempo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in VLDL-C
Lasso di tempo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in RC
Lasso di tempo: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in HbA1c
Lasso di tempo: 72 weeks
|
72 weeks
|
|
Incidence rate of acute pancreatitis
Lasso di tempo: 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)
Lasso di tempo: 72 weeks
|
72 weeks
|
|
Plasma Concentration of long-term HRS-7249 treatment
Lasso di tempo: 72 weeks
|
72 weeks
|
|
Dynamics of anti-drug antibody (ADA) following long-term HRS-7249 treatment
Lasso di tempo: 72 weeks
|
72 weeks
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- HRS-7249-203
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .