A Phase 2/3 interventional study of Placebo and Rosuvastatin Dose 1 in Dyslipidaemia, sponsored by AstraZeneca. Active, not recruiting at 42 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by AstraZeneca · Phase 2/3, Interventional, and Treatment
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 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 .
1,073 studies on the registry are indexed under Dyslipidemias; 158 are open to participants now.
This study's enrollment of 432 is above the median of 99 across 842 interventional studies indexed under Dyslipidemias.
Browse Dyslipidemias studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
PART A
PART B
(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).
For Cohort 2: Meet one of the following before screening (Visit 1):
Exclusion Criteria:
PART A
PART B
Any laboratory values with the following deviations at screening (Visit 1)
* 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 · Drug: AZD0780
* 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 · Drug: Rosuvastatin Dose 1
* 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 · Drug: AZD0780
* 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 · Drug: Rosuvastatin dose 2
• Participate will receive AZD0780 QD for 52 weeks (Part B Cohort 1)
Drug: AZD0780
• Participate will receive Placebo QD for 52 weeks (Part B Cohort 1)
Drug: Placebo
* 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 · Drug: AZD0780
* Participate receive Rosuvastatin Dose 1 for 28 days. * Then receive Placebo QD as add on for 12 weeks (Part B Cohort 2)
Drug: Placebo · Drug: Rosuvastatin Dose 1
Administered orally as tablets
Administered orally as tablets
Administered orally as tablets
Administered orally as tablets
AZD0780 Concentrations in plasma (PART A)
To characterise the single dose and steady state PK of AZD0780 following oral administration of AZD0780 (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)
AZD0780 PK Parameter: AUC0-t (PART A, intensive PK subgroup).
To characterise the single dose and steady state PK of AZD0780 following oral administration of AZD0780 (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)
AZD0780 PK parameter: Cmax (PART A, intensive PK subgroup)
To characterise the single dose and steady state PK of AZD0780 following oral administration of AZD0780 (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)
AZD0780 PK parameter: AUCtau (PART A, intensive PK sub group)
To characterise the single dose and steady state PK of AZD0780 following oral administration of AZD0780 (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)
Relative change in LDL-C 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)
Time frame: From baseline to 12 weeks (PART B)
Relative change from baseline of LDL-C at Week 4 (PART A)
To evaluate the effect of treatment with AZD0780 versus placebo on LDL-C at Week 4 (PART A)
Time frame: From baseline to Week 4 (PART A)
Relative change in LDL-C 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)
Time frame: From baseline to 12 weeks (PART B Cohort 2)
Relative change in LDL-C 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)
Time frame: From baseline to 12 weeks (PART B)
Indicator for LDL-C < 70 mg/dL (< 1.8 mmol/L) at 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)
Time frame: From baseline to 12 weeks (PART B)
Indicator for LDL-C < 55 mg/dL (< 1.4 mmol/L) at 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)
Time frame: From baseline to 12 weeks (PART B)
Relative change in LDL-C from baseline to 28 weeks (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)
Time frame: From baseline to Week 28 (PART B cohort 1)
Relative change in LDL-C from baseline to 52 weeks (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)
Time frame: From baseline to Week 52 (PART B cohort 1)
Relative change in lipid panel from baseline to 12 weeks (PART B cohort 2)
To compare the effect of treatment with AZD0780 versus placebo on lipid panel at 12 weeks (PART B cohort 2)
Time frame: From baseline to Week 12 (PART B cohort 2)
Number of participants with adverse events (PART A)
To assess the safety and tolerability of AZD0780 following oral administration of multiple doses (PART A)
Time frame: From baseline up to Day 39 (PART A)
Number of participants with adverse events (PART B)
To assess the safety and tolerability of AZD0780 versus placebo (PART B)
Time frame: Cohort 1: From baseline up to Day 375 (PART B) Cohort 2: From baseline up to Day 95 (PART B)
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap
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