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Une étude pour évaluer l'efficacité, la sécurité et la pharmacocinétique de l'AZD0780 chez les participants atteints de dyslipidémie

12 novembre 2026 mis à jour par: AstraZeneca

Une étude de phase II séquentielle en double aveugle, contrôlée par placebo, multi-centres, de phase II et de phase III pour évaluer l'efficacité, la sécurité et la pharmacocinétique de l'AZD0780 administrée jusqu'à 52 semaines dans les participants atteints de dyslipidémie

This is a randomised, double-blind, placebo-controlled, multi-centre, sequential Phase II and Phase III study that will evaluate the efficacy, safety, and PK of AZD0780 administered orally for up to 52 weeks in participants with elevated LDL-C. The study consist of 2 separate parts (Part A and Part B) approximately 60 participants will be randomised in Part A. There will be 2 cohorts in Part B (approximately 220 participants in Cohort 1 and 100 participants in Cohort 2).

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Description détaillée

The planned study includes 2 parts. Part A will be the Phase II study and aims to evaluate the PK, PD, safety, and tolerability of AZD0780. Part B will be the Phase III study and aims to evaluate the reduction of LDL-C as well as the safety and tolerability after oral administration of AZD0780 on background lipid-lowing therapy including moderate to high-intensity statins.

For Part A, approximately 60 participants who meet the eligibility criteria will be randomised. Part A will comprise 4 periods totalling up to 80 days.

For Part B, approximately 220 participants who meet the eligibility criteria will be randomised in Cohort 1, and approximately 100 participants who meet the eligibility criteria will be randomised in Cohort 2.

Cohort 1: participants are on a stable dose of LLTs, including moderate to high-intensity statins for≥ 28 days before screening.

Cohort 2: participants could be with moderate-intensity or without statins therapy (not due to statin intolerance) in background LLTs or not on any LLTs .

Type d'étude

Interventionnel

Inscription (Réel)

432

Phase

  • Phase 2
  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Chine
      • Baotou, Chine, 14010
        • Research Site
      • Beijing, Chine, 100050
        • Research Site
      • Beijing, Chine, 100029
        • Research Site
      • Bengbu, Chine, 233004
        • Research Site
      • Changchun, Chine, 130021
        • Research Site
      • Changchun, Chine, 130033
        • Research Site
      • Changde, Chine, 415000
        • Research Site
      • Changsha, Chine, 410015
        • Research Site
      • Changzhou, Chine, 272100
        • Research Site
      • Chengdu, Chine, 610000
        • Research Site
      • Chongqing, Chine, 402260
        • Research Site
      • Daqing, Chine, 163000
        • Research Site
      • Deyang, Chine, 618000
        • Research Site
      • Guangzhou, Chine, 510100
        • Research Site
      • Guangzhou, Chine, 510220
        • Research Site
      • Hengyang, Chine, 421001
        • Research Site
      • Heze, Chine, 274099
        • Research Site
      • Linhai, Chine, 317000
        • Research Site
      • Luoyang, Chine, 471000
        • Research Site
      • Nanchang, Chine, 330009
        • Research Site
      • Nanchong, Chine, 637900
        • Research Site
      • Nanjing, Chine, 210009
        • Research Site
      • Pingxiang, Chine, 337055
        • Research Site
      • Qiqihar, Chine, 161000
        • Research Site
      • Sanya, Chine, 572000
        • Research Site
      • Shanghai, Chine, 200032
        • Research Site
      • Shanghai, Chine, 200120
        • Research Site
      • Shenyang, Chine, 110016
        • Research Site
      • Shenyang, Chine, 110004
        • Research Site
      • Siping, Chine, 136000
        • Research Site
      • Taiyuan, Chine, 030024
        • Research Site
      • Tianjin, Chine, 300457
        • Research Site
      • Wuhan, Chine, 430030
        • Research Site
      • Wuhan, Chine, 430060
        • Research Site
      • Wuhan, Chine, 430010
        • Research Site
      • Xi'an, Chine, 710068
        • Research Site
      • Xianyang, Chine, 750004
        • Research Site
      • Yinchuan, Chine, 750004
        • Research Site
      • Zigong, Chine, 643021
        • Research Site
  • Hong Kong
      • Hong Kong, Hong Kong, 999077
        • Research Site

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

PART A

  1. Males, and females of non-childbearing potential, 18 to 55 years of age, at the time of signing the informed consent.
  2. Diagnosis of dyslipidaemia: and with fasting LDL-C ≥ 100 mg/dL (2.6 mmol/L) and < 190 mg/dL (4.9 mmol/L) at screening (Visit 1).
  3. Fasting triglycerides < 400 mg/dL (< 4.52 mmol/L) at screening (Visit 1).
  4. Not on any LLTs for ≥ 8 weeks prior to screening (Visit 1), except for a heart-healthy lifestyle.
  5. No planned LLTs using during study participation.
  6. Body mass index ≥ 18 and ≤35 kg/m^2 , weigh ≥50 kg and ≤120 kg.

PART B

  1. Males, and females, ≥ 18 years of age, at the time of signing the informed consent.
  2. Meets one of the ASCVD status/risk categories and has a corresponding fasted LDL-C value at screening (Visit 1) .

(1) Participants with clinical ASCVD, LDL-C ≥ 55 mg/dl (ultra-high risk) and ≥ 70 mg/dl (very high risk).

(2) Participants without clinical ASCVD, at moderate to high risk for ASCVD at 10 years, LDL-C ≥ 100 mg/dl. ASCVD risk equivalents [diabetes mellitus,LDL-C ≥ 4.9 mmol/L or TC ≥ 7.2 mmol/L, HeFH, CKD (stage 3-5)] are also eligible.

3. Fasting triglycerides < 400 mg/dL (< 4.52 mmol/L).

4. Background LLTs:

For Cohort 1: on a stable dose of LLTs including medications and supplements ≥ 28 days before screening (Visit 1). , that typically include moderate to high-intensity statins for ≥ 28 days before screening (LLTs include medications [eg, statins, ezetimibe, niacin] and supplements [eg, omega-3 fatty acids] that can affect cholesterol levels).

  1. Participants intolerant to moderate or high intensity statins per the 2023 Chinese Guideline may be included if treated with a low intensity statin.
  2. Participants not on statins must have documented intolerance to at least two statins (including one at the lowest standard dose) or be on chronic medication contraindicating statin use.

For Cohort 2: Meet one of the following before screening (Visit 1):

  1. On a stable dose of LLTs including moderate statins .
  2. On a stable dose of LLTs without any statins.
  3. Not received treatment with any LLTs.

Exclusion Criteria:

PART A

  1. Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in-situ, or Stage 1 prostate carcinoma) within the last 10 years.
  2. Recipient of any major organ transplant, eg, lung, liver, heart, bone marrow, renal.
  3. Homozygous familial hypercholesterolaemia, Know diagnosis of HeFH, LDL apheresis or plasma apheresis within 12 months prior to screening (Visit 1).
  4. QTcF > 450 ms; high degree atrioventricular-block grade II-III and sinus node dysfunction with significant sinus pause untreated with pacemaker; and cardiac tachyarrhythmias.
  5. A LDL-C reduction that is < 30% post rosuvastatin run-in period (Day -8).

PART B

  1. Acute ischaemic ASCVD event within 7 days prior to screening (Visit 1).

  2. Any uncontrolled or serious disease.

  3. eGFR < 15 mL/min/1.73m2 using the CKD-EPI 2021 (age, sex) equation at screening (Visit 1).

  4. Uncontrolled type 2 diabetes mellitus, defined as HbA1c ≥ 9.5% at screening (Visit 1).

  5. Heart failure with New York Heart Association Class IV.

  6. Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma) within 5 years prior to screening (Visit 1).

  7. Severe concomitant non-CVD with risk of life expectancy < 2 years.

  8. Recipient of any major organ transplant, eg, lung, liver, heart, bone marrow, renal.

  9. Homozygous familial hypercholesterolaemia, LDL apheresis, or plasma apheresis within 12 months prior to screening or any other underlying known disease or condition that may interfere with interpretation of the clinical study results as judged by the Investigator.

  10. Uncontrolled hypertension defined as average sitting SBP > 160 mmHg or DBP > 110 mmHg at screening (Visit 1) or randomization despite antihypertensive therapy (based on the mean of the 3 consecutive readings).

  11. Any laboratory values with the following deviations at screening (Visit 1)

    1. Any positive result on screening for hepatitis B or hepatitis C.
    2. ALT > 3 × ULN.
    3. AST > 3 × ULN.
    4. TBL > 2 × ULN (except for participants with Gilberts syndrome, where TBL 3 × ULN is acceptable provided direct bilirubin < 1.5 × ULN)
    5. Creatine kinase > 5 × ULN
    6. Urine albumin-to-creatinine ratio ≥ 500 mg/g

  12. QTcF > 470 ms; high degree atrioventricular-block grade II-III and sinus node dysfunction with significant sinus pause untreated with pacemaker; and cardiac tachyarrhythmias.

  13. Current administration of PCSK9 inhibitor, siRNA or mAb (approved or investigational) at screening.

  14. Mipomersen or microsomal triglyceride transfer protein inhibitor (eg, lomitapide) use within 12 months prior to screening or planned ues during the study.

  15. Use of PCSK-9 inhibitors: evolocumab/alirocumab within 12 weeks, inclisiran within 18 months, tafolecimab, ebronucimab, ongericimab, and recaticimab within 3 to 6 months before screening or planned use during the study; or any other PCSK-9 inhibitor within 5 half-lives before screening or planned use during the study.

  16. Use of any lipid-lowing traditional Chinese medicine (expect Xuezhikang) within 8 weeks before screening.

  17. Use of gemfibrozil within one week before screening or planned use during the study.

  18. Receiving, or has received within 14 days of screening, medication with a black box warning for significant QT prolongation.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: AZD0780 +Rosuvastatin Dose 1 (Part A)
  • Participants will receive Rosuvastatin Dose 1 QD for minimum 21 days (up to 28 days)
  • Then receive AZD0780 QD as add on for next 28 days (Part A)
Médicament: Rosuvastatin Dose 1

Administered orally as tablets

Médicament: AZD0780

Administered orally as tablets
Comparateur placebo: Placebo +Rosuvastatin Dose 1 (Part A)
  • Participants will receive Rosuvastatin Dose 1 QD for minimum 21 days (up to 28 days)
  • Then receive Placebo QD as add on for next 28 days (Part A)
Médicament: Rosuvastatin Dose 1

Administered orally as tablets

Médicament: Placebo

Administered orally as tablets
Expérimental: AZD0780 +Rosuvastatin Dose 2 (Part A)
  • Participants will receive Rosuvastatin Dose 2 QD for minimum 21 days (up to 28 days)
  • Then receive AZD0780 QD as add on for next for 28 days (Part A)
Médicament: AZD0780

Administered orally as tablets

Médicament: Rosuvastatin dose 2

Administered orally as tablets
Comparateur placebo: Placebo + Rosuvastatin Dose 2 (Part A)
  • Participants will receive Rosuvastatin Dose 2 QD for minimum 21 days (up to 28 days)
  • Then receive Placebo QD as add on for 28 days (Part A)
Médicament: Placebo

Administered orally as tablets

Médicament: Rosuvastatin dose 2

Administered orally as tablets
Expérimental: AZD0780 (Part B Cohort 1)

• Participate will receive AZD0780 QD for 52 weeks (Part B Cohort 1)
Médicament: AZD0780

Administered orally as tablets
Comparateur placebo: Placebo (Part B Cohort 1)

• Participate will receive Placebo QD for 52 weeks (Part B Cohort 1)
Médicament: Placebo

Administered orally as tablets
Expérimental: AZD0780+Rosuvastatin Dose 1 (Part B Cohort 2)
  • Participate receive Rosuvastatin Dose 1 for 28 days.
  • Then receive AZD0780 QD as add on for 12 weeks (Part B Cohort 2)
Médicament: Rosuvastatin Dose 1

Administered orally as tablets

Médicament: AZD0780

Administered orally as tablets
Comparateur placebo: Placebo+Rosuvastation Dose 1 (Part B Cohort 2)
  • Participate receive Rosuvastatin Dose 1 for 28 days.
  • Then receive Placebo QD as add on for 12 weeks (Part B Cohort 2)
Médicament: Rosuvastatin Dose 1

Administered orally as tablets

Médicament: Placebo

Administered orally as tablets

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
AZD0780 Concentrations in plasma (PART A)
Délai: Day 1 and Day 8: Pre-dose, 0.25,0.5,1,1.5,2,3,4,6,8,12,16 hours post-dose. Day 2, Day 9, Day 11, Day 15, Day 22, Day 29: Pre-dose (PART A)

To characterise the single dose and steady state PK of AZD0780 following oral administration of AZD0780 (PART A)
Day 1 and Day 8: Pre-dose, 0.25,0.5,1,1.5,2,3,4,6,8,12,16 hours post-dose. Day 2, Day 9, Day 11, Day 15, Day 22, Day 29: Pre-dose (PART A)
AZD0780 PK Parameter: AUC0-t (PART A, intensive PK subgroup).
Délai: Day 1 and Day 8: Pre-dose, 0.25,0.5,1,1.5,2,3,4,6,8,12,16 hours post-dose. Day 2, Day 9, Day 11, Day 15, Day 22, Day 29: Pre-dose (PART A)

To characterise the single dose and steady state PK of AZD0780 following oral administration of AZD0780 (PART A)
Day 1 and Day 8: Pre-dose, 0.25,0.5,1,1.5,2,3,4,6,8,12,16 hours post-dose. Day 2, Day 9, Day 11, Day 15, Day 22, Day 29: Pre-dose (PART A)
AZD0780 PK parameter: Cmax (PART A, intensive PK subgroup)
Délai: Day 1 and Day 8: Pre-dose, 0.25,0.5,1,1.5,2,3,4,6,8,12,16 hours post-dose. Day 2, Day 9, Day 11, Day 15, Day 22, Day 29: Pre-dose (PART A)

To characterise the single dose and steady state PK of AZD0780 following oral administration of AZD0780 (PART A)
Day 1 and Day 8: Pre-dose, 0.25,0.5,1,1.5,2,3,4,6,8,12,16 hours post-dose. Day 2, Day 9, Day 11, Day 15, Day 22, Day 29: Pre-dose (PART A)
AZD0780 PK parameter: AUCtau (PART A, intensive PK sub group)
Délai: Day 1 and Day 8: Pre-dose, 0.25,0.5,1,1.5,2,3,4,6,8,12,16 hours post-dose. Day 2, Day 9, Day 11, Day 15, Day 22, Day 29: Pre-dose (PART A)

To characterise the single dose and steady state PK of AZD0780 following oral administration of AZD0780 (PART A)
Day 1 and Day 8: Pre-dose, 0.25,0.5,1,1.5,2,3,4,6,8,12,16 hours post-dose. Day 2, Day 9, Day 11, Day 15, Day 22, Day 29: Pre-dose (PART A)
Relative change in LDL-C from baseline to 12 weeks (PART B)
Délai: From baseline to 12 weeks (PART B)

To compare the effect of treatment with AZD0780 versus placebo on LDL-C at 12 weeks (PART B)
From baseline to 12 weeks (PART B)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Relative change from baseline of LDL-C at Week 4 (PART A)
Délai: From baseline to Week 4 (PART A)

To evaluate the effect of treatment with AZD0780 versus placebo on LDL-C at Week 4 (PART A)
From baseline to Week 4 (PART A)
Relative change in LDL-C from baseline to 12 weeks (PART B Cohort 2)
Délai: From baseline to 12 weeks (PART B Cohort 2)

To compare the effect of treatment with AZD0780 versus placebo on LDL-C at 12 weeks in Cohort 2 (PART B)
From baseline to 12 weeks (PART B Cohort 2)
Relative change in LDL-C from baseline to 12 weeks (PART B)
Délai: From baseline to 12 weeks (PART B)

To compare the effect of treatment with AZD0780 versus placebo on LDL-C at 12 weeks in participants on background statin therapy at baseline (PART B)
From baseline to 12 weeks (PART B)
Indicator for LDL-C < 70 mg/dL (< 1.8 mmol/L) at 12 weeks (PART B)
Délai: From baseline to 12 weeks (PART B)

To compare the effect of treatment with AZD0780 versus placebo on the probability of LDL-C < 70 mg/dL at 12 weeks in participants with baseline LDL-C ≥ 70 mg/dL (PART B)
From baseline to 12 weeks (PART B)
Indicator for LDL-C < 55 mg/dL (< 1.4 mmol/L) at 12 weeks (PART B)
Délai: From baseline to 12 weeks (PART B)

To compare the effect of treatment with AZD0780 versus placebo on the probability of LDL-C < 55 mg/dL at 12 weeks (PART B)
From baseline to 12 weeks (PART B)
Relative change in LDL-C from baseline to 28 weeks (PART B cohort 1)
Délai: From baseline to Week 28 (PART B cohort 1)

To compare the effect of treatment with AZD0780 versus placebo on LDL-C at 28 weeks in Cohort 1 (PART B cohort 1)
From baseline to Week 28 (PART B cohort 1)
Relative change in LDL-C from baseline to 52 weeks (PART B cohort 1)
Délai: From baseline to Week 52 (PART B cohort 1)

To compare the effect of treatment with AZD0780 versus placebo on LDL-C at 52 weeks in Cohort 1 (PART B cohort 1)
From baseline to Week 52 (PART B cohort 1)
Relative change in lipid panel from baseline to 12 weeks (PART B cohort 2)
Délai: From baseline to Week 12 (PART B cohort 2)

To compare the effect of treatment with AZD0780 versus placebo on lipid panel at 12 weeks (PART B cohort 2)
From baseline to Week 12 (PART B cohort 2)

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Number of participants with adverse events (PART A)
Délai: From baseline up to Day 39 (PART A)

To assess the safety and tolerability of AZD0780 following oral administration of multiple doses (PART A)
From baseline up to Day 39 (PART A)
Number of participants with adverse events (PART B)
Délai: Cohort 1: From baseline up to Day 375 (PART B) Cohort 2: From baseline up to Day 95 (PART B)

To assess the safety and tolerability of AZD0780 versus placebo (PART B)
Cohort 1: From baseline up to Day 375 (PART B) Cohort 2: From baseline up to Day 95 (PART B)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

AstraZeneca

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

6 décembre 2024

Achèvement primaire (Estimé)

22 février 2027

Achèvement de l'étude (Estimé)

22 février 2027

Dates d'inscription aux études

Première soumission

2 décembre 2024

Première soumission répondant aux critères de contrôle qualité

18 février 2025

Première publication (Réel)

19 février 2025

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

13 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • D7960C00008

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Délai de partage IPD

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Critères d'accès au partage IPD

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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