A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of AZD0780 in Participants With Dyslipidaemia
NCT06834932 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 432
Last updated 2026-05-11
Summary
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).
Conditions
- Dyslipidaemia
Interventions
- DRUG
-
Administered orally as tablets
- DRUG
-
Rosuvastatin Dose 1
Administered orally as tablets
- DRUG
-
Rosuvastatin dose 2
Administered orally as tablets
- DRUG
-
AZD0780
Administered orally as tablets
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-06
- Primary Completion
- 2027-02-22
- Completion
- 2027-02-22
Countries
- China
- Hong Kong
Study Locations
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