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AZD0780

Phase 3

Heterozygous Familial Hypercholesterolaemia | Small molecule | Metabolic |AstraZeneca PLC|Last Updated: Jul 16, 2026

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment473

FDA Designations

No designations recorded

Clinical trial landscape

AZD0780 · 16 trials · 9 indications

Phase 3 3Phase 2 4Phase 1 9
NCT07000136A Phase III Study to Assess the Effect of AZD0780 on LDL-C in Patients With HeFHHeterozygous Familial Hypercholesterolaemia
ACTIVE NOT_RECRUITING473 Analytics
NCT07000357A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a First EventCardiovascular Disease
RECRUITING15,100 Analytics
NCT07000123A Phase III Study to Assess the Effect of AZD0780 on LDL-C in Patients With Clinical ASCVD or at Risk for a First ASCVD EventCardiovascular Disease
ACTIVE NOT_RECRUITING3,103 Analytics
PHASE3ACTIVE NOT_RECRUITING
A Phase III Study to Assess the Effect of AZD0780 on LDL-C in Patients With HeFH
Heterozygous Familial Hypercholesterolaemia
NCT07000136473
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PHASE3RECRUITING
A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a First Event
Cardiovascular Disease
NCT0700035715,100
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PHASE3ACTIVE NOT_RECRUITING
A Phase III Study to Assess the Effect of AZD0780 on LDL-C in Patients With Clinical ASCVD or at Risk for a First ASCVD Event
Cardiovascular Disease
NCT070001233,103
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Study Endpoints

Primary Endpoints

Relative change in LDL-C from baseline to 12 weeks
Baseline - 12 weeks

To compare the effect of treatment with AZD0780 versus placebo on LDL-C at 12 weeks

Time to first event of any component of MACE-PLUS
Up to approximately 54 months

To compare the effect of treatment with AZD0780 to placebo in reducing the risk of MACE-PLUS (the composite of CV death, myocardial infarction \[MI\], ischaemic stroke, acute lower limb ischaemia, major amputation of a vascular aetiology, and urgent arterial revascularisation)

Relative change in Low-density lipoprotein cholesterol (LDL-C) from baseline to 12 weeks
Baseline - 12 weeks

To compare the effect of treatment with AZD0780 versus placebo on LDL-C at 12 weeks

AZD0780 Concentrations in plasma (PART A)
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)

To characterise the single dose and steady state PK of AZD0780 following oral administration of AZD0780 (PART A)

AZD0780 PK Parameter: AUC0-t (PART A, intensive PK subgroup).
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)

To characterise the single dose and steady state PK of AZD0780 following oral administration of AZD0780 (PART A)

AZD0780 PK parameter: Cmax (PART A, intensive PK subgroup)
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)

To characterise the single dose and steady state PK of AZD0780 following oral administration of AZD0780 (PART A)

AZD0780 PK parameter: AUCtau (PART A, intensive PK sub group)
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)

To characterise the single dose and steady state PK of AZD0780 following oral administration of AZD0780 (PART A)

Relative change in LDL-C from baseline to 12 weeks (PART B)
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)

To assess the effect of treatment with AZD0780 dose 1 versus placebo on ambulatory 24-hour average SBP at Week 4
Week 4

Change from baseline in ambulatory 24-hour average systolic blood pressure (SBP) at Week 4

Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) Level From Baseline to Week 12
From first day of treatment up to week 12

Percent change was calculated as (Week 12 LDL-C - Baseline LDL-C) / Baseline LDL-C \* 100. Negative values indicate reduction in LDL-C. Baseline is the last non-missing value prior to first administration of study treatment. Hypothetical estimand: data collected after intercurrent events (ICEs) defined in the CSP excluded.

Relative change from baseline in LDL-C levels
From Baseline (Day 1) to 4 weeks

To determine the pharmacodynamic profile of AZD0780 versus placebo by evaluating LDL-C concentrations after repeated oral administration

Area under concentration time curve from time 0 to infinity (AUCinf)
Days 1 to 3 and Days 8 to 10

To assess the effect of AZD0780 on the PK of metformin.

Area under concentration curve from time 0 to the last quantifiable concentration (AUClast)
Days 1 to 3 and Days 8 to 10

To assess the effect of AZD0780 on the PK of metformin.

Maximum observed drug concentration (Cmax)
Days 1 to 3 and Days 8 to 10

To assess the effect of AZD0780 on the PK of metformin.

Change from baseline in direct Low-density Lipsprotein Cholesterol (LDL-C)
Week 4

To evaluate the effect of AZD0780 on LDL-C levels versus placebo when dosed with ezetimibe or ezetimibe and rosuvastatin or ezetimibe and bempedoic acid.

Number of participants with adverse events
From screening (Day -56 to -29) to 14 Weeks

The safety and tolerability of AZD0780 when dosed with ezetimibe or ezetimibe and rosuvastatin or ezetimibe and bempedoic acid will be assessed.

AUCinf (Area under concentration-time curve from time 0 to infinity)
Period 1 (Day 1 to 11 Cohort 1 and Cohort 2) and Period 3 (Day 14-24 Part 1 and Day 27-37 Part 2)

To describe the PK of AZD0780 when administered alone and in combination with itraconazole and carbamazepine.

AUClast (Area under concentration curve from time 0 to the last quantifiable concentration)
Period 1 (Day 1 to 11 Cohort 1 and Cohort 2) and Period 3 (Day 14-24 Part 1 and Day 27-37 Part 2)

To describe the PK of AZD0780 when administered alone and in combination with itraconazole and carbamazepine.

Cmax (Maximum observed drug concentration)
Period 1 (Day 1 to 11 Cohort 1 and Cohort 2) and Period 3 (Day 14-24 Part 1 and Day 27-37 Part 2)

To describe the PK of AZD0780 when administered alone and in combination with itraconazole and carbamazepine.

AUCinf
Period 1 (Day 1 to 2 Part 3 and Day 1 to 7 Part 4) and Period 3 (Day 11-12 Part 3 and Day 16 to 22 Part 4)

To assess the effect of AZD0780 on the PK of midazolam (Part 3) and EE and LNG (Part 4).

AUClast
Period 1 (Day 1 to 2 Part 3 and Day 1 to 7 Part 4) and Period 3 (Day 11-12 Part 3 and Day 16 to 22 Part 4)

To assess the effect of AZD0780 on the PK of midazolam (Part 3) and EE and LNG (Part 4).

Cmax
Period 1 (Day 1 to 2 Part 3 and Day 1 to 7 Part 4) and Period 3 (Day 11-12 Part 3 and Day 16 to 22 Part 4)

To assess the effect of AZD0780 on the PK of midazolam (Part 3) and EE and LNG (Part 4).

Absolute bioavailability (F) - Part 1
Plasma sample collection from pre-dose to 168 hours post-dose

Absolute bioavailability based on AUC0-inf of oral formulation compared to IV adjusted for dose

Area under the curve from time 0 extrapolated to infinity for AZD0780 and total radioactivity (AUC0-inf) - Part 1
Plasma sample collection from pre-dose until 168 hours post-dose

PK of AZD0780 and \[14C\]AZD0780 in plasma

Time to maximum concentration (tmax) for AZD0780 and total radioactivity - Part 1
Plasma sample collection from pre-dose until 168 hours post-dose

PK of AZD0780 and \[14C\]AZD0780 in plasma

Maximum observed concentration (Cmax) for AZD0780 and total radioactivity - Part 1
Plasma sample collection from pre-dose until 168 hours post-dose

PK of AZD0780 and \[14C\]AZD0780 in plasma

Area under the curve from time 0 to the time of last measurable concentration for AZD0780 and total radioactivity (AUC0-t) - Part 1
Plasma sample collection from pre-dose until 168 hours post-dose

PK of AZD0780 and \[14C\]AZD0780 in plasma

Area under the curve from time of the last measurable concentration to infinity as a percentage of the area under the curve extrapolated to infinity (AUCextrap) and total radioactivity - Part 1
Plasma sample collection from pre-dose until 168 hours post-dose

PK of AZD0780 and \[14C\]AZD0780 in plasma

Terminal elimination half-life for AZD0780 (t1/2) and total radioactivity - Part 1
Plasma sample collection from pre-dose until 168 hours post-dose

PK of AZD0780 and \[14C\]AZD0780 in plasma

First order rate constant associated with the terminal (log-linear) portion of the curve for AZD0780 (λz) and total radioactivity - Part 1
Plasma sample collection from pre-dose until 168 hours post-dose

PK of AZD0780 and \[14C\]AZD0780 in plasma

Total body clearance calculated after a single IV administration (CL) - Part 1
Plasma sample collection from pre-dose until 168 hours post-dose

PK of AZD0780 and \[14C\]AZD0780 in plasma

Total body clearance calculated after a single extravascular administration where F (fraction of dose bioavailable) is unknown (CL/F) - Part 1
Plasma sample collection from pre-dose until 168 hours post-dose

PK of AZD0780 and \[14C\]AZD0780 in plasma

Volume of distribution based on the terminal phase calculated using AUC(0-inf) after a single IV administration (Vz) - Part 1
Plasma sample collection from pre-dose until 168 hours post-dose

PK of AZD0780 and \[14C\]AZD0780 in plasma

Volume of distribution at steady state after a single IV administration (Vss) - Part 1
Plasma sample collection from pre-dose until 168 hours post-dose

PK of AZD0780 and \[14C\]AZD0780 in plasma

Apparent volume of distribution based on the terminal phase calculated using AUC(0-inf) after a single extravascular administration where F (fraction of dose bioavailable) is unknown (Vz/F) - Part 1
Plasma sample collection from pre-dose until 168 hours post-dose

PK of AZD0780 and \[14C\]AZD0780 in plasma

Amount of AZD0780 excreted (Ae) - Part 2
Urine and faecal samples collected from pre-dose until 240 hours post-dose

Mass balance of total radioactivity (TR) of \[14C\]AZD0780 in urine and faecal samples

Amount of AZD0780 excreted expressed as a fraction of dose excreted (%Ae) - Part 2
Urine and faecal samples collected from pre-dose until 240 hours post-dose

Mass balance of total radioactivity (TR) of \[14C\]AZD0780 in urine and faecal samples

The cumulative amount of AZD0780 exreted (CumAe) - Part 2
Urine and faecal samples collected from pre-dose until 240 hours post-dose

Mass balance of total radioactivity (TR) of \[14C\]AZD0780 in urine and faecal samples

Cumulative amount of AZD0780 excreted expressed as a fraction of dose excreted (Cum%Ae) - Part 2
Urine and faecal samples collected from pre-dose until 240 hours post-dose

Mass balance of total radioactivity (TR) of \[14C\]AZD0780 in urine and faecal samples

Time to maximum concentration (tmax) for AZD0780 and total radioactivity - Part 2
Urine and faecal samples collected from pre-dose until 240 hours post-dose

PK of AZD0780 in urine and faeces

Maximum observed concentration (Cmax) for AZD0780 and total radioactivity - Part 2
Urine and faecal samples collected from pre-dose until 240 hours post-dose

PK of AZD0780 in urine and faeces

Area under the curve from time 0 to the time of last measurable concentration for AZD0780 and total radioactivity (AUC0-t) - Part 2
Urine and faecal samples collected from pre-dose until 240 hours post-dose

PK of AZD0780 in urine and faeces

Area under the curve from time 0 extrapolated to infinity for AZD0780 and total radioactivity (AUC0-inf) - Part 2
Urine and faecal samples collected from pre-dose until 240 hours post-dose

PK of AZD0780 in urine and faeces

Area under the curve from time of the last measurable concentration to infinity as a percentage of the area under the curve extrapolated to infinity (AUCextrap) and total radioactivity - Part 2
Urine and faecal samples collected from pre-dose until 240 hours post-dose

PK of AZD0780 in urine and faeces

Terminal elimination half-life for AZD0780 (t1/2) and total radioactivity - Part 2
Urine and faecal samples collected from pre-dose until 240 hours post-dose

PK of AZD0780 in urine and faeces

First order rate constant associated with the terminal (log-linear) portion of the curve for AZD0780 (λz) and total radioactivity - Part 2
Urine and faecal samples collected from pre-dose until 240 hours post-dose

PK of AZD0780 in urine and faeces

Total body clearance calculated after a single extravascular administration where F (fraction of dose bioavailable) is unknown (CL/F) - Part 2
Urine and faecal samples collected from pre-dose until 240 hours post-dose

PK of AZD0780 in urine and faeces

Apparent volume of distribution based on the terminal phase calculated using AUC(0-inf) after a single extravascular administration where F (fraction of dose bioavailable) is unknown (Vz/F) - Part 2
Urine and faecal samples collected from pre-dose until 240 hours post-dose

PK of AZD0780 in urine and faeces

Renal clearance calculated using plasma AUC (CLR) - Part 2
Urine and faecal samples collected from pre-dose until 240 hours post-dose

PK of AZD0780 in urine and faeces

Area under plasma concentration-time curve from 0 to infinity (AUCinf) of Rosuvastatin
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose

The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.

Area under the plasma concentration-curve from 0 to the last quantifiable concentration (AUClast) of Rosuvastatin
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose

The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.

Maximum observed plasma concentration (Cmax) of Rosuvastatin
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose

The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.

Terminal elimination half-life (t½λz) of Rosuvastatin
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose

The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.

Time to reach maximum observed concentration (tmax) of Rosuvastatin
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose

The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.

Apparent total body clearance (CL/F) of Rosuvastatin
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose

The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.

Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) of Rosuvastatin
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose

The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.

Area under plasma concentration-time curve from 0 to infinity (AUCinf) of AZD0780
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose

The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.

Area under the plasma concentration-curve from 0 to the last quantifiable concentration (AUClast) of AZD0780
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose

The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.

Maximum observed plasma concentration (Cmax) of AZD0780
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose

The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.

Time to reach maximum observed concentration (tmax) of AZD0780
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose

The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.

Terminal elimination half-life (t½λz) of AZD0780
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose

The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.

Apparent total body clearance (CL/F) of AZD0780
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose

The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.

Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) of AZD0780
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose

The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.

Number of subjects with Adverse Events
From Screening (≤ 28 days) until Follow-up Visit (5 to 7 days post-dose for all cohorts, and 9 to 11 days post-dose for subjects from Cohort 3 onwards)

The safety and tolerability of AZD0780 following oral administration of single ascending doses (Part A) and multiple ascending doses (Part B) will be assessed.

Secondary Endpoints

Relative change in LDL-C from baseline to 12 weeks
Baseline - 12 weeks
Indicator for LDL-C < 70 mg/dL (< 1.8 mmol/L) at 12 weeks
Baseline - 12 weeks
Indicator for LDL-C < 55 mg/dL (< 1.4 mmol/L) at 12 weeks
Baseline - 12 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AZD0780EXPERIMENTALParticipants will receive daily oral dose of AZD0780
PlaceboPLACEBO_COMPARATORParticipants will receive daily oral dose of placebo
AZD0780 +RosuvastatinEXPERIMENTALParticipants will receive Rosuvastatin for 28 days. Then receive AZD0780 on top of rosuvastatin, administered orally for 12 weeks
Placebo +RosuvastatinPLACEBO_COMPARATORParticipants will receive Rosuvastatin for 28 days. Then receive Placebo on top of rosuvastatin, administered orally for 12 weeks
AZD0780 +Rosuvastatin Dose 1 (Part A)EXPERIMENTAL* 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 +Rosuvastatin Dose 1 (Part A)PLACEBO_COMPARATOR* 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)
AZD0780 +Rosuvastatin Dose 2 (Part A)EXPERIMENTAL* 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 + Rosuvastatin Dose 2 (Part A)PLACEBO_COMPARATOR* 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)
AZD0780 (Part B Cohort 1)EXPERIMENTAL• Participate will receive AZD0780 QD for 52 weeks (Part B Cohort 1)
Placebo (Part B Cohort 1)PLACEBO_COMPARATOR• Participate will receive Placebo QD for 52 weeks (Part B Cohort 1)
AZD0780+Rosuvastatin Dose 1 (Part B Cohort 2)EXPERIMENTAL* Participate receive Rosuvastatin Dose 1 for 28 days. * Then receive AZD0780 QD as add on for 12 weeks (Part B Cohort 2)
Placebo+Rosuvastation Dose 1 (Part B Cohort 2)PLACEBO_COMPARATOR* Participate receive Rosuvastatin Dose 1 for 28 days. * Then receive Placebo QD as add on for 12 weeks (Part B Cohort 2)
Arm AEXPERIMENTALAZD0780, Dose 1
Arm BEXPERIMENTALAZD0780, Dose 2
Arm CEXPERIMENTALAZD0780, Dose 3
Arm DEXPERIMENTALAZD0780, Dose 4
Arm EPLACEBO_COMPARATORPlacebo, matched for appearance
Metformin/Metformin + AZD0780EXPERIMENTALParticipants will receive a single dose of metformin on Day 1 in Treatment Period 1 followed by a washout period of 7 days. In Treatment Period 2, participants will receive a single dose of AZD0780 followed by a single dose of metformin on Day 8.
Ezetimibe + AZD0780EXPERIMENTALParticipants will receive ezetimibe 10 mg and AZD0780 once daily (QD) for 4 weeks.
Rosuvastatin + Ezetimibe + AZD0780EXPERIMENTALParticipants will receive rosuvastatin 20 mg, ezetimibe 10 mg and AZD0780 QD for 4 weeks.
Bempedoic Acid + Ezetimibe + AZD0780 (Optional Cohort)EXPERIMENTALParticipants will receive bempedoic acid 180 mg, ezetimibe 10 mg and AZD0780 QD for 4 weeks.
Ezetimibe + PlaceboPLACEBO_COMPARATORParticipants will receive ezetimibe 10 mg and placebo QD for 4 weeks.
Rosuvastatin + Ezetimibe + PlaceboPLACEBO_COMPARATORParticipants will receive rosuvastatin 20 mg, ezetimibe 10 mg and placebo QD for 4 weeks.
Bempedoic Acid + Ezetimibe + Placebo (Optional Cohort)PLACEBO_COMPARATORParticipants will receive bempedoic acid 180 mg, ezetimibe 10 mg and placebo QD for 4 weeks.
Itraconazole CohortEXPERIMENTAL* All participants will receive 2 single doses of dose 1 of AZD0780 and 14 doses of itraconazole, under fed conditions. * This part will consist of Period 1 (AZD0780 administration only), Period 2 (itraconazole administration only), and Period 3 (AZD0780 + itraconazole administration).
Carbamazepine CohortEXPERIMENTAL* All participants will receive 2 single doses of dose 1 of AZD0780 and 6 doses of 100 mg, 6 doses of 200 mg, and 40 doses of 300 mg carbamazepine, under fed conditions. * This part will consist of Period 1 (AZD0780 administration only), Period 2 (carbamazepine administration only), and Period 3 (AZD0780 + carbamazepine administration)
Midazolam CohortEXPERIMENTAL* All participants will receive 10 single doses of AZD0780 dose 2 and 2 doses of midazolam. On midazolam dosing days, participants will receive midazolam under fasted conditions. * This part will consist of Period 1 (midazolam administration only), Period 2 (AZD0780 administration only), and Period 3 (AZD0780 + midazolam administration).
EE and LNG CohortEXPERIMENTAL* All participants will receive 15 single doses of AZD0780 dose 2 and 2 doses of EE and LNG. On EE and LNG dosing days, participants will receive EE and LNG under fasted conditions. * This part will consist of Period 1 (EE and LNG administration only), Period 2 (AZD0780 administration only), and Period 3 (AZD0780 + EE and LNG administration).
Group 1EXPERIMENTALSubjects with Moderate Impairment will receive a single oral dose of AZD0780 under fasted conditions.
Group 2EXPERIMENTALHealthy participants will receive a single oral dose of AZD0780 under fasted conditions.
Group 3 (optional)EXPERIMENTALSubjects with Mild Impairment will receive a single oral dose of AZD0780 under fasted conditions.
Group 1: AZD0780EXPERIMENTALParticipants with severe renal impairment (eGFR \< 30 mL/min), not on dialysis.
Group 2: AZD0780EXPERIMENTALParticipants with ESRD (eGFR \< 15 mL/min) on a stable intermittent HD schedule for at least 3 months prior to planned dosing.
Group 3: AZD0780EXPERIMENTALParticipants with normal renal function demographically matched by sex, age, and body mass index (BMI) to the impaired participants (eGFR of ≥ 90 mL/min)
Group 4 (optional): AZD0780EXPERIMENTALParticipants with moderate renal impairment (eGFR ≥ 30 to \< 60 mL/min).
Treatment sequence A-BEXPERIMENTALParticipants will receive treatments in the following sequence, a single dose of rosuvastatin tablet alone (Treatment A) in period 1, and then a single dose of rosuvastatin tablet + Dose X AZD0780 tablet (Treatment B) in period 2.
Treatment sequence B-AEXPERIMENTALParticipants will receive 1 treatment during each study period in the following sequence: a single dose of rosuvastatin tablet + AZD0780 tablet (Treatment B) in period 1 and then a single dose of rosuvastatin tablet alone (Treatment A) in period 2.
Cohort 1: Part A1 - AZD0780 dose 1/placebo tabletACTIVE_COMPARATORA total of 6 subjects will receive single ascending doses of AZD0780 and 2 will receive placebo.
Cohort 2: Part A1 - AZD0780 dose 2/placebo tabletACTIVE_COMPARATORA total of 6 subjects will receive single ascending doses of AZD0780 and 2 will receive placebo.
Cohort 3: Part A1 - AZD0780 dose 3/placebo tabletACTIVE_COMPARATORA total of 6 subjects will receive single ascending doses of AZD0780 and 2 will receive placebo.
Cohort 4: Part A1 - AZD0780 dose 4/placebo tabletACTIVE_COMPARATORA total of 6 subjects will receive single ascending doses of AZD0780 and 2 will receive placebo.
Cohort 5: Part A1 - AZD0780 dose 5/placebo tabletACTIVE_COMPARATORA total of 6 subjects will receive single ascending doses of AZD0780 and 2 will receive placebo.
Cohort 6: Part B - AZD0780 dose 6/placebo tabletACTIVE_COMPARATORA total of 20 subjects will be assigned as 3:1::AZD0780:Placebo to receive multiple ascending doses.
Cohort 7: Part B - AZD0780 dose 7/placebo tabletACTIVE_COMPARATORA total of 20 subjects will be assigned as 3:1::AZD0780:Placebo to receive multiple ascending doses.
Cohort 8: Part B - AZD0780 dose 8/placebo tabletACTIVE_COMPARATORA total of 20 subjects will be assigned as 3:1::AZD0780:Placebo to receive multiple ascending doses.
Cohort 9: Part B - AZD0780 dose 9/placebo tabletACTIVE_COMPARATORA total of 6 subjects will receive single and multiple ascending doses of AZD0780 and 2 will receive placebo.
Cohort 10: Part B - AZD0780 dose 10/placebo tabletACTIVE_COMPARATORA total of 6 subjects will receive single and multiple ascending doses of AZD0780 and 2 will receive placebo.
Cohort 11: Part A2 - AZD0780 dose 11/placebo tabletACTIVE_COMPARATORA total of 5 subjects will receive single ascending doses of AZD0780 and placebo.
Cohort 12: Part B - AZD0780 dose 1/rosuvastatin dose 12ACTIVE_COMPARATORA total of 20 subjects will receive single dose of AZD0780 and rosuvastatin.
Cohort 13: Part B - placebo tablet/rosuvastatin dose 12ACTIVE_COMPARATORA total of 20 subjects will receive single dose of placebo and rosuvastatin.
Cohort 14: Part B - AZD0780 with placebo tablet/AZD0780 with rosuvastatin dose 12ACTIVE_COMPARATORA total of 20 subjects will receive AZD0780 in combination with rosuvastatin or 5 subjects will receive placebo in combination with rosuvastatin.

Interventions

NameTypeDescription
AZD0780DRUGParticipants will receive daily oral dose of AZD0780
PlaceboDRUGParticipants will receive daily oral dose of placebo
RosuvastatinDRUGAdministered orally as tablets
Rosuvastatin Dose 1DRUGAdministered orally as tablets
Rosuvastatin dose 2DRUGAdministered orally as tablets
MetforminDRUGMetformin will be administered orally.
EzetimibeDRUGEzetimibe tablet will be administered orally.
Bempedoic AcidDRUGBempedoic Acid tablet will be administered orally.
ItraconazoleDRUG* Period 2 (itraconazole administration only). * Period 3 (AZD0780 + itraconazole administration).
CarbamazepineDRUG* Period 2 (carbamazepine administration only). * Period 3 (AZD0780 + carbamazepine administration only).
MidazolamDRUG* Period 1 (midazolam administration only). * Period 3 (AZD0780 + midazolam administration).
Ethinyl estradiol/levonorgestrelDRUG* Period 1 (EE and LNG administration only). * Period 3 (AZD0780 + EE and LNG administration).
AZD0780 tabletDRUGoral, fasted
[14C]AZD0780 Solution for InfusionDRUGintravenous
[14C]AZD0780 Oral SolutionDRUGoral, fasted
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites133

Inclusion criteria: •≥ 18 years of age at the time of signing the ICF. * Diagnosis of HeFH by genetic confirmation or a definite clinical diagnosis, ie, a score \> x using the Dutch Lipid Network \[Nordestgaard et al 2013\] or equivalent as per internationally accepted diagnostic algorithms (AHA \...

Countries:United StatesArgentinaAustraliaBrazilBulgariaCanadaChileCzechiaDenmarkFinlandFranceGermanyHungaryJapanNetherlandsNew ZealandNorwaySlovakiaSouth KoreaSpainSwedenTaiwanTurkey (Türkiye)VietnamChinaColombiaGreeceIndiaItalyMalaysiaMexicoPeruPhilippinesPolandPuerto RicoRomaniaSouth AfricaThailandUkraineUnited KingdomRussiaHong Kong
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Recent Changes (Last 90 Days)

LOWJul 17, 2026NCT07000123lastUpdatePostDate: changed
LOWJul 17, 2026NCT07000136lastUpdatePostDate: changed
LOWJul 17, 2026NCT07000123lastUpdatePostDate: changed
LOWJul 17, 2026NCT07000136lastUpdatePostDate: changed
LOWJul 17, 2026NCT07000123lastUpdatePostDate: changed
LOWJul 17, 2026NCT07000136lastUpdatePostDate: changed
HIGHJul 7, 2026NCT07423598Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJul 7, 2026NCT07423598Status: ACTIVE_NOT_RECRUITING → COMPLETED
LOWJul 2, 2026NCT07000357lastUpdatePostDate: changed
LOWJul 2, 2026NCT07000357lastUpdatePostDate: changed
LOWJun 29, 2026NCT07423598primaryCompletionDate: changed
LOWJun 29, 2026NCT07423598primaryCompletionDate: changed
LOWJun 4, 2026NCT07000357lastUpdatePostDate: changed
MEDIUMJun 4, 2026NCT07218900Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWJun 4, 2026NCT07000357lastUpdatePostDate: changed
MEDIUMJun 4, 2026NCT07218900Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWJun 4, 2026NCT07000357lastUpdatePostDate: changed
MEDIUMJun 4, 2026NCT07218900Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWJun 4, 2026NCT07000357lastUpdatePostDate: changed
MEDIUMJun 4, 2026NCT07218900Status: RECRUITING → ACTIVE_NOT_RECRUITING

Frequently asked questions about AZD0780

What is AZD0780 used for?

AZD0780 is an investigational small molecule being developed for cardiovascular conditions, including dyslipidemia, heterozygous familial hypercholesterolaemia, atherosclerotic cardiovascular disease, and cardiovascular disease. It is also being studied in patients with hepatic impairment and renal impairment. The drug is not approved and remains in clinical development.

Who makes AZD0780?

AZD0780 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker AZN. AstraZeneca is conducting clinical trials of AZD0780 across multiple countries, including the United States, United Kingdom, and Japan.

What phase is AZD0780 in?

AZD0780 is in Phase 2 clinical development, though it has also been studied in Phase 1 and Phase 3 trials. The drug is investigational and has not been approved by regulatory authorities. Its development program includes completed early-phase studies and ongoing late-stage trials.

What clinical trials is AZD0780 in?

AZD0780 has been studied in four clinical trials. Completed trials include NCT05817461, a Phase 1 ADME study in healthy males, and NCT07423598, a Phase 1 study in healthy adults with elevated LDL-C. Active trials include NCT07000123, a Phase 3 study in patients with clinical ASCVD or at risk, and NCT07000357, a Phase 3 study on major adverse cardiovascular events.

Is AZD0780 the same as any other drug?

AZD0780 is the sole name provided for this investigational drug. No alternative names or brand names have been associated with it in the available clinical trial information. It is identified only by its development code AZD0780 across all registered studies.