Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AZD0780 tablet, Laroprovstat
AZD0780 · 15 trials · 9 indications
To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on LDL-C at 8 weeks
To compare the effect of treatment with AZD0780 versus placebo on LDL-C at 12 weeks
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)
To compare the effect of treatment with AZD0780 versus placebo on LDL-C at 12 weeks
Change from baseline in ambulatory 24-hour average systolic blood pressure (SBP) at Week 4
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.
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.
The safety and tolerability of AZD0780 when dosed with ezetimibe or ezetimibe and rosuvastatin or ezetimibe and bempedoic acid will be assessed.
To describe the PK of AZD0780 when administered alone and in combination with itraconazole and carbamazepine.
To describe the PK of AZD0780 when administered alone and in combination with itraconazole and carbamazepine.
To describe the PK of AZD0780 when administered alone and in combination with itraconazole and carbamazepine.
To assess the effect of AZD0780 on the PK of midazolam (Part 3) and EE and LNG (Part 4).
To assess the effect of AZD0780 on the PK of midazolam (Part 3) and EE and LNG (Part 4).
To assess the effect of AZD0780 on the PK of midazolam (Part 3) and EE and LNG (Part 4).
Absolute bioavailability based on AUC0-inf of oral formulation compared to IV adjusted for dose
PK of AZD0780 and \[14C\]AZD0780 in plasma
PK of AZD0780 and \[14C\]AZD0780 in plasma
PK of AZD0780 and \[14C\]AZD0780 in plasma
PK of AZD0780 and \[14C\]AZD0780 in plasma
PK of AZD0780 and \[14C\]AZD0780 in plasma
PK of AZD0780 and \[14C\]AZD0780 in plasma
PK of AZD0780 and \[14C\]AZD0780 in plasma
PK of AZD0780 and \[14C\]AZD0780 in plasma
PK of AZD0780 and \[14C\]AZD0780 in plasma
PK of AZD0780 and \[14C\]AZD0780 in plasma
PK of AZD0780 and \[14C\]AZD0780 in plasma
PK of AZD0780 and \[14C\]AZD0780 in plasma
Mass balance of total radioactivity (TR) of \[14C\]AZD0780 in urine and faecal samples
Mass balance of total radioactivity (TR) of \[14C\]AZD0780 in urine and faecal samples
Mass balance of total radioactivity (TR) of \[14C\]AZD0780 in urine and faecal samples
Mass balance of total radioactivity (TR) of \[14C\]AZD0780 in urine and faecal samples
PK of AZD0780 in urine and faeces
PK of AZD0780 in urine and faeces
PK of AZD0780 in urine and faeces
PK of AZD0780 in urine and faeces
PK of AZD0780 in urine and faeces
PK of AZD0780 in urine and faeces
PK of AZD0780 in urine and faeces
PK of AZD0780 in urine and faeces
PK of AZD0780 in urine and faeces
PK of AZD0780 in urine and faeces
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
The safety and tolerability of AZD0780 following oral administration of single ascending doses (Part A) and multiple ascending doses (Part B) will be assessed.
| Arm | Type | Description |
|---|---|---|
| laroprovstat/rosuvastatin dose 1 | EXPERIMENTAL | Patient will receive a daily dose of laroprovstat/rosuvastatin 1 and a placebo to match rosuvastatin 1 |
| rosuvastatin dose 1 | ACTIVE_COMPARATOR | Patient will receive a daily dose of rosuvastatin 1 and placebo to match laroprovstat/rosuvastatin 1 |
| laroprovstat/rosuvastatin dose 2 | EXPERIMENTAL | Patient will receive a daily dose of laroprovstat/rosuvastatin 2 and a placebo to match rosuvastatin 2 |
| rosuvastatin dose 2 | ACTIVE_COMPARATOR | Patient will receive a daily dose of rosuvastatin 2 and placebo to match laroprovstat/rosuvastatin 2 |
| laroprovstat/rosuvastatin dose 3 | EXPERIMENTAL | Patient will receive a daily dose of laroprovstat/rosuvastatin 3 and a placebo to match rosuvastatin 3 |
| rosuvastatin dose 3 | ACTIVE_COMPARATOR | Patient will receive a daily dose of rosuvastatin 3 and placebo to match laroprovstat/rosuvastatin 3 |
| laroprovstat/rosuvastatin dose 4 | EXPERIMENTAL | Patient will receive a daily dose of laroprovstat/rosuvastatin 4 and a placebo to match rosuvastatin 4 |
| rosuvastatin dose 4 | ACTIVE_COMPARATOR | Patient will receive a daily dose of rosuvastatin 4 and placebo to match laroprovstat/rosuvastatin 4 |
| Laroprovstat | ACTIVE_COMPARATOR | The patient will receive a daily dose of Laroprovstat |
| Placebo | PLACEBO_COMPARATOR | The patient will receive a daily dose of Placebo |
| Laroprovstat/Rosuvastatin dose combination 1 | EXPERIMENTAL | The patient will receive a daily dose of Laroprovstat/Rosuvastatin 1 |
| Laroprovstat/Rosuvastatin dose combination 2 | EXPERIMENTAL | The patient will receive a daily dose of Laroprovstat/Rosuvastatin 2 |
| AZD0780 | EXPERIMENTAL | Participants will receive daily oral dose of AZD0780 |
| AZD0780 +Rosuvastatin | EXPERIMENTAL | Participants will receive Rosuvastatin for 28 days. Then receive AZD0780 on top of rosuvastatin, administered orally for 12 weeks |
| Placebo +Rosuvastatin | PLACEBO_COMPARATOR | Participants will receive Rosuvastatin for 28 days. Then receive Placebo on top of rosuvastatin, administered orally for 12 weeks |
| Arm A | EXPERIMENTAL | AZD0780, Dose 1 |
| Arm B | EXPERIMENTAL | AZD0780, Dose 2 |
| Arm C | EXPERIMENTAL | AZD0780, Dose 3 |
| Arm D | EXPERIMENTAL | AZD0780, Dose 4 |
| Arm E | PLACEBO_COMPARATOR | Placebo, matched for appearance |
| Ezetimibe + AZD0780 | EXPERIMENTAL | Participants will receive ezetimibe 10 mg and AZD0780 once daily (QD) for 4 weeks. |
| Rosuvastatin + Ezetimibe + AZD0780 | EXPERIMENTAL | Participants will receive rosuvastatin 20 mg, ezetimibe 10 mg and AZD0780 QD for 4 weeks. |
| Bempedoic Acid + Ezetimibe + AZD0780 (Optional Cohort) | EXPERIMENTAL | Participants will receive bempedoic acid 180 mg, ezetimibe 10 mg and AZD0780 QD for 4 weeks. |
| Ezetimibe + Placebo | PLACEBO_COMPARATOR | Participants will receive ezetimibe 10 mg and placebo QD for 4 weeks. |
| Rosuvastatin + Ezetimibe + Placebo | PLACEBO_COMPARATOR | Participants will receive rosuvastatin 20 mg, ezetimibe 10 mg and placebo QD for 4 weeks. |
| Bempedoic Acid + Ezetimibe + Placebo (Optional Cohort) | PLACEBO_COMPARATOR | Participants will receive bempedoic acid 180 mg, ezetimibe 10 mg and placebo QD for 4 weeks. |
| Itraconazole Cohort | EXPERIMENTAL | * 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 Cohort | EXPERIMENTAL | * 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 Cohort | EXPERIMENTAL | * 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 Cohort | EXPERIMENTAL | * 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 1 | EXPERIMENTAL | Subjects with Moderate Impairment will receive a single oral dose of AZD0780 under fasted conditions. |
| Group 2 | EXPERIMENTAL | Healthy participants will receive a single oral dose of AZD0780 under fasted conditions. |
| Group 3 (optional) | EXPERIMENTAL | Subjects with Mild Impairment will receive a single oral dose of AZD0780 under fasted conditions. |
| Group 1: AZD0780 | EXPERIMENTAL | Participants with severe renal impairment (eGFR \< 30 mL/min), not on dialysis. |
| Group 2: AZD0780 | EXPERIMENTAL | Participants with ESRD (eGFR \< 15 mL/min) on a stable intermittent HD schedule for at least 3 months prior to planned dosing. |
| Group 3: AZD0780 | EXPERIMENTAL | Participants 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): AZD0780 | EXPERIMENTAL | Participants with moderate renal impairment (eGFR ≥ 30 to \< 60 mL/min). |
| Treatment sequence A-B | EXPERIMENTAL | Participants 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-A | EXPERIMENTAL | Participants 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 tablet | ACTIVE_COMPARATOR | A total of 6 subjects will receive single ascending doses of AZD0780 and 2 will receive placebo. |
| Cohort 2: Part A1 - AZD0780 dose 2/placebo tablet | ACTIVE_COMPARATOR | A total of 6 subjects will receive single ascending doses of AZD0780 and 2 will receive placebo. |
| Cohort 3: Part A1 - AZD0780 dose 3/placebo tablet | ACTIVE_COMPARATOR | A total of 6 subjects will receive single ascending doses of AZD0780 and 2 will receive placebo. |
| Cohort 4: Part A1 - AZD0780 dose 4/placebo tablet | ACTIVE_COMPARATOR | A total of 6 subjects will receive single ascending doses of AZD0780 and 2 will receive placebo. |
| Cohort 5: Part A1 - AZD0780 dose 5/placebo tablet | ACTIVE_COMPARATOR | A total of 6 subjects will receive single ascending doses of AZD0780 and 2 will receive placebo. |
| Cohort 6: Part B - AZD0780 dose 6/placebo tablet | ACTIVE_COMPARATOR | A 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 tablet | ACTIVE_COMPARATOR | A 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 tablet | ACTIVE_COMPARATOR | A 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 tablet | ACTIVE_COMPARATOR | A 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 tablet | ACTIVE_COMPARATOR | A 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 tablet | ACTIVE_COMPARATOR | A total of 5 subjects will receive single ascending doses of AZD0780 and placebo. |
| Cohort 12: Part B - AZD0780 dose 1/rosuvastatin dose 12 | ACTIVE_COMPARATOR | A total of 20 subjects will receive single dose of AZD0780 and rosuvastatin. |
| Cohort 13: Part B - placebo tablet/rosuvastatin dose 12 | ACTIVE_COMPARATOR | A total of 20 subjects will receive single dose of placebo and rosuvastatin. |
| Cohort 14: Part B - AZD0780 with placebo tablet/AZD0780 with rosuvastatin dose 12 | ACTIVE_COMPARATOR | A total of 20 subjects will receive AZD0780 in combination with rosuvastatin or 5 subjects will receive placebo in combination with rosuvastatin. |
| Name | Type | Description |
|---|---|---|
| laroprovstat/rosuvastatin 1 | COMBINATION_PRODUCT | daily oral dose of the laroprovstat/rosuvastatin 1 |
| laroprovstat/rosuvastatin 2 | COMBINATION_PRODUCT | daily oral dose of the laroprovstat/rosuvastatin 2 |
| laroprovstat/rosuvastatin 3 | COMBINATION_PRODUCT | daily oral dose of the laroprovstat/rosuvastatin 3 |
| laroprovstat/rosuvastatin 4 | COMBINATION_PRODUCT | daily oral dose of the laroprovstat/rosuvastatin 4 |
| Placebo to match laroprovstat/rosuvastatin 1,2,3 | DRUG | Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 1,2,3 |
| Placebo to match laroprovstat/rosuvastatin 4 | DRUG | Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 4 |
| Rosuvastatin 1 | DRUG | daily oral dose of rosuvastatin 1 |
| Rosuvastatin 2 | DRUG | daily oral dose of rosuvastatin 2 |
| Rosuvastatin 3 | DRUG | daily oral dose of rosuvastatin 3 |
| Rosuvastatin 4 | DRUG | daily oral dose of rosuvastatin 4 |
| Placebo to match Rosuvastatin | DRUG | daily oral dose of placebo to match rosuvastatin |
| Laroprovstat | DRUG | daily oral dose of the Laroprovstat |
| Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1 | DRUG | daily oral dose of the Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1 |
| Placebo to match Laroprovstat/Rosuvastatin 2 | DRUG | daily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2 |
| AZD0780 | DRUG | Participants will receive daily oral dose of AZD0780 |
| Placebo | DRUG | Participants will receive daily oral dose of placebo |
| Rosuvastatin | DRUG | Administered orally as tablets |
| Ezetimibe | DRUG | Ezetimibe tablet will be administered orally. |
| Bempedoic Acid | DRUG | Bempedoic Acid tablet will be administered orally. |
| Itraconazole | DRUG | * Period 2 (itraconazole administration only). * Period 3 (AZD0780 + itraconazole administration). |
| Carbamazepine | DRUG | * Period 2 (carbamazepine administration only). * Period 3 (AZD0780 + carbamazepine administration only). |
| Midazolam | DRUG | * Period 1 (midazolam administration only). * Period 3 (AZD0780 + midazolam administration). |
| Ethinyl estradiol/levonorgestrel | DRUG | * Period 1 (EE and LNG administration only). * Period 3 (AZD0780 + EE and LNG administration). |
| AZD0780 tablet | DRUG | oral, fasted |
| [14C]AZD0780 Solution for Infusion | DRUG | intravenous |
| [14C]AZD0780 Oral Solution | DRUG | oral, fasted |
Inclusion Criteria: * Participant must be ≥ 18 years of age * Participants must be on a stable dose of all background LLTs * The stable statin dose should be judged as their maximally tolerated dose * Participants should have either history of a clinical ASCVD event or be at increased risk for a fi...
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AZD0780 is being developed to lower low-density lipoprotein cholesterol (LDL-C) in patients with dyslipidaemia, heterozygous familial hypercholesterolaemia (HeFH), and atherosclerotic cardiovascular disease (ASCVD). It is also under study to reduce major adverse cardiovascular events in patients with a history of ASCVD or at high risk for a first event.
AZD0780 targets PCSK9, a protein that regulates LDL receptor recycling. By inhibiting PCSK9, AZD0780 increases the availability of LDL receptors on the liver, which enhances the clearance of LDL cholesterol from the blood. This mechanism is intended to lower LDL-C levels in patients with dyslipidaemia and related cardiovascular conditions.
AZD0780 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is responsible for the clinical development program of AZD0780, including the ongoing Phase 3 trials.
AZD0780 is in Phase 3 clinical development. A Phase 2 trial in dyslipidaemia has been completed, and three Phase 3 trials are currently ongoing or active. The Phase 3 program includes studies in heterozygous familial hypercholesterolaemia and in patients with or at risk for atherosclerotic cardiovascular disease.
AZD0780 is being evaluated in four clinical trials. The completed Phase 2 trial is NCT07218900. The Phase 3 trials are NCT07000357 (recruiting), NCT07000136 (active, not recruiting), and NCT07000123 (active, not recruiting). These trials are randomized, double-blind, and placebo-controlled.
Yes, AZD0780 tablet is another name for AZD0780. The drug is administered as an oral tablet. AZD0780 is a small molecule PCSK9 inhibitor being developed by AstraZeneca for cardiovascular and lipid disorders.