Study identifier:D7960C00008
ClinicalTrials.gov identifier:NCT06834932
EudraCT identifier:N/A
CTIS identifier:N/A
A Randomised, Double-blind, Placebo-controlled, Multi-centre, Sequential Phase II, and Phase III Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of AZD0780 Administered for up to 52 Weeks in Participants with Dyslipidaemia
dyslipidaemia
Phase 2/3
No
Placebo, Rosuvastatin Dose 1, Rosuvastatin dose 2, AZD0780
All
300
Interventional
18 Years - n/a
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Mar 2025 by AstraZeneca
AstraZeneca
-
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).
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 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 .
Location
Status
Location
Shanghai, China, 200032
Status
Recruiting
Location
Chengdu, China, 610000
Status
Recruiting
Location
Hong Kong, Hong Kong
Status
Recruiting
Location
Hong Kong, Hong Kong, 999077
Status
Recruiting
Location
Xi'an, China, 710068
Status
Recruiting
Location
Tianjin, China, 300457
Status
Recruiting
Location
Beijing, China, 100029
Status
Recruiting
Location
Baotou, China, 14010
Status
Recruiting
Arms | Assigned Interventions |
---|---|
Experimental: 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) | Drug: Rosuvastatin Dose 1 Administered orally as tablets Drug: AZD0780 Administered orally as tablets |
Placebo Comparator: 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) | Drug: Placebo Administered orally as tablets Drug: Rosuvastatin Dose 1 Administered orally as tablets |
Experimental: 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) | Drug: Rosuvastatin dose 2 Administered orally as tablets Drug: AZD0780 Administered orally as tablets |
Placebo Comparator: 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) | Drug: Placebo Administered orally as tablets Drug: Rosuvastatin dose 2 Administered orally as tablets |
Experimental: AZD0780 (Part B Cohort 1) • Participate will receive AZD0780 QD for 52 weeks (Part B Cohort 1) | Drug: AZD0780 Administered orally as tablets |
Placebo Comparator: Placebo (Part B Cohort 1) • Participate will receive Placebo QD for 52 weeks (Part B Cohort 1) | Drug: Placebo Administered orally as tablets |
Experimental: 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) | Drug: Rosuvastatin Dose 1 Administered orally as tablets Drug: AZD0780 Administered orally as tablets |
Placebo Comparator: 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) | Drug: Placebo Administered orally as tablets Drug: Rosuvastatin Dose 1 Administered orally as tablets |
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