A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of AZD0780 in Participants With Dyslipidaemia
Trial Parameters
Brief 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).
Eligibility Criteria
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