A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of AZD0780 in Participants With Dyslipidaemia

Conditions

• Dyslipidaemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Placebo — DRUG
  Administered orally as tablets
• Rosuvastatin Dose 1 — DRUG
  Administered orally as tablets
• Rosuvastatin dose 2 — DRUG
  Administered orally as tablets
• AZD0780 — DRUG
  Administered orally as tablets

Study Details

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).

Key Dates

Start date

Dec 6, 2024

Status verified

May 2026

Primary completion

Feb 22, 2027

Completion

Feb 22, 2027

Study Design

Enrollment

432 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

AZD0780 Concentrations in plasma (PART A) [ Time Frame: 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) ]