- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- Phase 2
Contacts et emplacements
Coordonnées de l'étude
- Nom: Chanjuan Deng, MM
- Numéro de téléphone: 0518-82342973
- E-mail: Chanjuan.deng@hengrui.com
Sauvegarde des contacts de l'étude
- Nom: Jianpeng Su, MS
- Numéro de téléphone: 0518-82342973
- E-mail: jianpeng.su.js18@hengrui.com
Lieux d'étude
-
-
Shandong
-
Jinan, Shandong, Chine, 250014
- The First Affiliated Hospital of Shandong First Medical University (Qianfo Shan Hospital of shandong province).
-
Chercheur principal:
- Mei Gao
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Chine, 200030
- Shanghai Chest Hospital
-
Chercheur principal:
- Xumin Hou
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Arm 1
HRS-7249 Injection; Low dose, subcutaneous administration
|
Dosing level: Low dose
Dosing level: High dose
|
|
Expérimental: Arm 2
HRS-7249 Injection; High dose, subcutaneous administration
|
Dosing level: Low dose
Dosing level: High dose
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Injection site reactions
Délai: 48 weeks
|
48 weeks
|
|
All adverse events (AEs)
Délai: 72 weeks
|
72 weeks
|
|
Respiratory rate
Délai: 72 weeks
|
72 weeks
|
|
Pulse rate
Délai: 72 weeks
|
72 weeks
|
|
Systolic and diastolic blood pressure
Délai: 72 weeks
|
72 weeks
|
|
Body temperature
Délai: 72 weeks
|
72 weeks
|
|
Complete Blood Count
Délai: 72 weeks
|
72 weeks
|
|
Blood chemistry
Délai: 72 weeks
|
72 weeks
|
|
High-sensitivity C-reactive protein (hs-CRP)
Délai: 72 weeks;
|
72 weeks;
|
|
Heart rate
Délai: 72 weeks;
|
72 weeks;
|
|
PR interval
Délai: 72 weeks
|
72 weeks
|
|
QRS duration
Délai: 72 weeks
|
72 weeks
|
|
QT interval
Délai: 72 weeks
|
72 weeks
|
|
QTc interval
Délai: 72 weeks
|
72 weeks
|
|
Urinalysis
Délai: 72 weeks
|
72 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Proportion of patients with TG<1.7 mmol/L
Délai: 48 weeks
|
48 weeks
|
|
Proportion of patients with TG<2.3 mmol/L
Délai: 48 weeks
|
48 weeks
|
|
Proportion of patients with baseline TG≥5.7 mmol/L achieving TG<5.7 mmol/L
Délai: 48 weeks
|
48 weeks
|
|
Percentage change and absolute value change from baseline in TG
Délai: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in APOC3
Délai: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in HDL-C
Délai: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in TC
Délai: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in LDL-C
Délai: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in sdLDL-C
Délai: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in non-HDL-C
Délai: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in ApoB
Délai: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in ApoA1
Délai: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in Lp(a)
Délai: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in VLDL-C
Délai: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in RC
Délai: 72 weeks
|
72 weeks
|
|
Percentage change and absolute value change from baseline in HbA1c
Délai: 72 weeks
|
72 weeks
|
|
Incidence rate of acute pancreatitis
Délai: 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)
Délai: 72 weeks
|
72 weeks
|
|
Plasma Concentration of long-term HRS-7249 treatment
Délai: 72 weeks
|
72 weeks
|
|
Dynamics of anti-drug antibody (ADA) following long-term HRS-7249 treatment
Délai: 72 weeks
|
72 weeks
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HRS-7249-203
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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