DyslipidemiaPhase 1NCT05384262
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD0780 in Healthy Subjects
A Phase 1 study testing AZD0780 and Rosuvastatin in people with Dyslipidemia, run by AstraZeneca at 3 sites in 2 countries.
Trial summary
This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD0780 following single and multiple dose administration to healthy subjects with or without elevated Low-Density Lipoprotein-Cholesterol (LDL-C) levels. This study will consist of two parts (Parts A and B). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- AZD0780 and Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 183 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 18 May 2022to 14 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated, written informed consent prior to any study specific procedures (including the Pre Screening Visit for Part B).
- Healthy male and female subjects (of nonchildbearing potential), aged 18 to 55 years inclusive, with suitable veins for cannulation or repeated venipuncture.
- Females must have a negative pregnancy test at the Screening Visit and on admission to the study center, must not be lactating and must be of non childbearing potential, confirmed at the Screening Visit by fulfilling one of the following criteria:
- Postmenopausal defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments and FSH levels in the postmenopausal range.
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
- Have a BMI between 18 and 35 kg/m2 inclusive and weigh at least 50 kg and no more than 120 kg inclusive at the Screening Visit and on admission to the study center.
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- For Japanese subjects (Part B) and Chinese subjects (Part A):
- A subject will be considered Japanese if both parents and all grandparents are Japanese, the subject was born in Japan, and the subject has not lived outside Japan for more than 10 years.
- A subject will be considered Chinese if both parents and all grandparents are Chinese, the subject was born in China, and the subject has not lived outside China for more than 10 years.
- For Part B (MAD), at the Screening Visit subjects must have LDL-C ≥ 70 mg/dL but ≤ 190 mg/dL (or ≥ 1.8 mmol/L but ≤ 4.9 mmol/L for London EPCU [Early Phase Clinical Unit]), and triglycerides < 400 mg/dL (or < 10.3 mmol/L for London EPCU).
- For Part B (rosuvastatin global MAD), at the Screening Visit subjects must have LDL-C ≥ 100 mg/dL but < 190 mg/dL (≥ 2.6 mmol/L but ≤ 4.9 mmol/L for London EPCU).
Who cannot join
- History of any clinically important disease or disorder.
- History or presence of gastrointestinal, hepatic or, renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
- Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) first vaccination within 30 days prior to randomization.
- SARS-CoV-2 second vaccination within 10 days of screening.
- Confirmed Coronavirus disease 2019 (COVID-19) infection during screening and admission, by Polymerase Chain Reaction (PCR) test (in the London EPCU, COVID-19 infection before or during Screening and/or admission will be confirmed by a COVID-19 test. Subjects will undergo COVID-19 testing prior to ICF signing and any subject testing positive will not be screened for the study).
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- Any clinically important abnormalities in clinical chemistry, coagulation, hematology, or urinalysis results.
- Any positive result on Screening for serum hepatitis B surface antigen, hepatitis C antibody, and Human immunodeficiency virus (HIV).
- Abnormal vital signs after 10 minutes supine rest at the Screening Visit and on admission to the study center.
- Any clinically important abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically important abnormalities in the 12-lead ECG that may interfere with the interpretation of ECG interval measured from the onset of the QRS complex to the end of the T wave (QT) corrected for heart rate (QTc) interval changes including abnormal ST-T-wave morphology at the Screening Visit and/or on admission to the study center.
- Known or suspected history of drug abuse.
- Current smokers or those who have smoked or used nicotine products within the previous 3 months.
- History of alcohol abuse or excessive intake of alcohol.
- Positive screen for drugs of abuse, cotinine (nicotine), or alcohol at Screening and/or admission to the study center.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD0780.
- Excessive intake of caffeine-containing drinks or food.
- Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP.
- Use of any prescribed or nonprescribed medication including antacids, analgesics, herbal remedies, mega-dose vitamins, and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half-life.
- Plasma donation within one month of the Screening Visit or any blood donation/blood loss during the 3 months prior to the Screening Visit.
- Has received another new chemical entity within 30 days or 5 half-lives of the first administration of IMP in this study.
- Subjects who have previously received AZD0780 within 60 days of the first administration of IMP in this study.
- Involvement of any Astra Zeneca or study center employee or their close relatives.
- Any ongoing or recent minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.
- Subjects who are vegans or have medical dietary restrictions.
- Subjects who cannot communicate reliably with the investigator.
- Vulnerable subjects.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Research Site
Brooklyn, Maryland, 21225
Research Site
Glendale, California, 91206
About this study
Official title: A Phase I, Randomized, Single-Blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD0780 Following Single and Multiple Ascending Dose Administration to Healthy Subjects With or Without Elevated LDL-C Levels
This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD0780 following single and multiple dose administration to healthy subjects with or without elevated Low-Density Lipoprotein-Cholesterol (LDL-C) levels.
This study will consist of two parts (Parts A and B).
56 subjects have been planned for Part A and 141 subjects for Part B. Additional subjects may be included for the optional cohorts depending upon emerging data.
Read the detailed description
This is a Phase I, First In Human (FIH), randomized, single-blind, placebo-controlled, study in healthy male and/or female subjects of non-childbearing potential including healthy subjects of Chinese and Japanese ethnicity performed at multiple centers (up to 4 study centers).
56 subjects have been planned for Part A and 141 subjects for Part B.
- Part A:
- A Screening Period of maximum 28 days.
- Admission to study center (Day -1 or Day -2).
- A Treatment Period (Day 1 to Day 3) with a single dose of AZD0780 or placebo on Day 1. Subjects will be discharged on Day 3.
- A Follow-up Visit within 5 to 7 days after the Investigational Medicinal Product (IMP) dose for all cohorts.
- An additional Follow-up Visit within 9 to 11 days after the IMP dose from Cohort 3 onwards. (i) Part A1 - Up to 5 dose cohorts of AZD0780 are planned to be investigated. Depending on the findings, up to 4 additional dose cohorts may be added. Within each cohort, 6 subjects will be randomized to receive AZD0780, and 2 subjects randomized to receive placebo. Dosing for each ascending dose cohort will proceed with 2 subjects in a sentinel sub-cohort such that one subject will be randomized to receive AZD0780, and one subject will be randomized to receive placebo. (ii) Part A2 - The subjects from a chosen cohort in Part A1 will return to the study center no sooner than 9 days after the first dose administration of IMP and will receive AZD0780 or placebo after intake of a high-calorie, high-fat breakfast, to assess the effect of food on the PK of AZD0780.
The subjects will stay at the study center until 48 hours post-dose in both the parts.
- Part B:
- Global Multiple Ascending Dose (MAD) cohort - Up to 3 dose cohorts are planned to be investigated. In each cohort, 20 subjects will participate and receive either AZD0780 or placebo, randomized 3:1 for 28 days dosing. Depending on the findings, 3 additional dose levels may be added in up to 3 additional cohorts (up to 20 subjects per cohort).
- Japanese Single and Multiple Ascending Dose (JSMAD) cohorts - Two cohorts are planned. One cohort of 8 Japanese subjects will receive a medium dose level of AZD0780 or placebo randomized 3:1 for 9 days dosing (subjects will receive a single dose of IMP on Day 1 followed by daily dosing on Days 8 to 15 [there is no dose on Days 2 to 7]). The second cohort of 8 Japanese subjects will receive a higher dose level of AZD0780 or placebo.
- Rosuvastatin global MAD cohorts - Two cohorts are planned. Up to 40 subjects in the first cohort will receive either AZD0780 in combination with rosuvastatin or placebo in combination with rosuvastatin, randomized 1:1 to 1 of the 2 treatment arms with 20 subjects per arm. Up to 25 subjects will participate in the second cohort and will be randomized 4:1 to 1 of 2 treatment arms to receive either AZD0780 in combination with rosuvastatin (20 subjects) or placebo in combination with rosuvastatin (5 subjects). Subjects eligible for these cohorts will begin a Screening period of 56 days, a minimum of 21 days run-in period (maximum of up to 28 days), Treatment period of 28 days for each cohort and two Follow-up visits (1 \& 2 weeks after last dose of IMP).
- Conditions
- Dyslipidemia
- Being tested
- AZD0780, Placebo, Rosuvastatin
- Keywords
- Elevated LDL-C, Hypercholesterolemia
- Medical subject headings
- Dyslipidemias, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD0780Drug
Subjects will receive AZD0780 orally as a single ascending dose.
AZD0780Drug
Subjects will receive AZD0780 orally as a multiple ascending dose.
AZD0780Drug
Subjects will receive AZD0780 orally as a single and multiple ascending dose.
PlaceboDrug
Subjects will receive placebo matching the AZD0780 dose orally as a single ascending dose.
PlaceboDrug
Subjects will receive placebo matching the AZD0780 dose orally as a multiple ascending dose.
PlaceboDrug
Subjects will receive placebo matching the AZD0780 dose orally as a single and multiple ascending dose.
RosuvastatinDrug
Subjects will receive rosuvastatin orally.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: AZD0780; Drug: 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. Receives: Drug: AZD0780; Drug: 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. Receives: Drug: AZD0780; Drug: 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. Receives: Drug: AZD0780; Drug: 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. Receives: Drug: AZD0780; Drug: 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. Receives: Drug: AZD0780; Drug: Placebo |
| 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. Receives: Drug: AZD0780; Drug: Placebo |
| 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. Receives: Drug: AZD0780; Drug: Placebo |
| 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. Receives: Drug: AZD0780; Drug: 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. Receives: Drug: AZD0780; Drug: 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. Receives: Drug: AZD0780; Drug: 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. Receives: Drug: AZD0780; Drug: 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. Receives: Drug: Placebo; Drug: 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. Receives: Drug: AZD0780; Drug: Placebo; Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with Adverse Events
The safety and tolerability of AZD0780 following oral administration of single ascending doses (Part A) and multiple ascending doses (Part B) will be assessed.
Measured: 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)
Secondary outcomes (9)
Area under plasma concentration time curve from zero to infinity (AUCinf)
The single dose and steady state AUCinf of AZD0780 following oral administration of AZD0780 will be assessed.
Measured: SAD cohorts: Day 1-3 until 5-7 days (cohort 1 & 2) & 9-11 days (cohort 3 onwards) post-dose; JSMAD cohorts: Day 1-3,5,8,10,13,15,16 until 7-10 days post-dose; MAD Cohorts: Day 1 to 3,5,8,9,12,15,18,22,25,29 until Days 36, 43 [± 1day]
Area under plasma concentration time curve from zero to t hours post-dose (AUC[0-t])
The single dose and steady state AUC(0-t) of AZD0780 following oral administration of AZD0780 will be assessed.
Measured: SAD cohorts: Day 1-3 until 5-7 days (cohort 1 & 2) & 9-11 days (cohort 3 onwards) post-dose; JSMAD cohorts: Day 1-3,5,8,10,13,15,16 until 7-10 days post-dose; MAD Cohorts: Day 1 to 3,5,8,9,12,15,18,22,25,29 until Days 36, 43 [± 1day]
Area under the plasma concentration-curve across the dosing interval (AUCτ)
The single dose and steady state AUCτ of AZD0780 following oral administration of AZD0780 will be assessed.
Measured: SAD cohorts: Day 1-3 until 5-7 days (cohort 1 & 2) & 9-11 days (cohort 3 onwards) post-dose; JSMAD cohorts: Day 1-3,5,8,10,13,15,16 until 7-10 days post-dose; MAD Cohorts: Day 1 to 3,5,8,9,12,15,18,22,25,29 until Days 36, 43 [± 1day]
Maximum observed plasma (peak) drug concentration [Cmax]
The single dose and steady state Cmax of AZD0780 following oral administration of AZD0780 will be assessed.
Measured: SAD cohorts: Day 1-3 until 5-7 days (cohort 1 & 2) & 9-11 days (cohort 3 onwards) post-dose; JSMAD cohorts: Day 1-3,5,8,10,13,15,16 until 7-10 days post-dose; MAD Cohorts: Day 1 to 3,5,8,9,12,15,18,22,25,29 until Days 36, 43 [± 1day]
Amount of unchanged drug excreted into urine from zero to the last quantifiable concentration by interval and cumulatively (Ae[0-last])
The single dose and steady state Ae[0-last] of AZD0780 following oral administration of AZD0780 will be assessed.
Measured: SAD cohorts (Parts A1 & A2): Day 1 to Day 3; JSMAD cohorts (Part B): Day 1 & 15; Global MAD Cohorts Day 1 & 10; Rosuvastatin Global MAD Cohorts (Part B): Day 1 & 8
Percentage of dose excreted unchanged in urine from zero to the last quantifiable concentration, by interval and cumulatively (fe[0-last])
The single dose and steady state fe[0-last] of AZD0780 following oral administration of AZD0780 will be assessed.
Measured: SAD cohorts (Parts A1 & A2): Day 1 to Day 3; JSMAD cohorts (Part B): Day 1 & 15; Global MAD Cohorts Day 1 & 10; Rosuvastatin Global MAD Cohorts (Part B): Day 1 & 8
Renal clearance of drug from plasma (CLR)
The single dose and steady state CLR of AZD0780 following oral administration of AZD0780 will be assessed.
Measured: SAD cohorts (Parts A1 & A2): Day 1 to Day 3; JSMAD cohorts (Part B): Day 1 & 15; Global MAD Cohorts Day 1 & 10; Rosuvastatin Global MAD Cohorts (Part B): Day 1 & 8
LDL-C
The pharmacodynamics (PD) of AZD0780 by assessment of LDL-C following oral administration of single ascending doses (Part A) and multiple ascending doses (Part B) will be assessed.
Measured: LDL-C SAD cohorts: Days 1,2,3,5-7,9-11 LDL-C JSMAD cohorts: Days 1,2,3,10,15,16,17;LDL-C Global MAD Cohorts: Days 1,2,3,5,8,12,22, 25,29,36-43;LDL-C Rosuvastatin Global MAD Cohorts:Days -28,-8,-1,1,2,3,5,8,12,15,18,22,29,36-43
Proprotein convertase subtilisin/kexin type 9 (PCSK9)
The PD of AZD0780 by assessment of total PCSK9 (and compound stabilized PCSK9 for Part A) following oral administration of single ascending doses (Part A) will be assessed.
Measured: PCSK9 SAD cohorts: Days 1,2,3;PCSK9 JSMAD cohorts:Days 1,2,3,10,15,16,17,22-25;PCSK9 Global MAD Cohorts:Days 1,8,15,22,29,36-43; PCSK9 Rosuvastatin Global MAD Cohorts:Days 1,8,15,22,29,36-43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start18 May 2022
- Primary completion14 Jun 2024
- Study completion14 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be a randomized, single-blind (study center staff including the Principal Investigator \[PI\] to remain blinded during the dosing phase of each cohort), placebo-controlled, Single Ascending Dose (SAD)/MAD, parallel type design in healthy male and/or female subjects, performed at multiple study centers.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384262
- Sponsor's protocol ID
- D7960C00001
- Other IDs
- 2022-002221-10
- Status last verified
- Sep 2026
- First submitted
- 17 May 2022
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Vega RB, O'Mahony G, Barbour AM, Yu H, Knochel J, Brengdahl J, Hochdorfer T, Bergenholm L, Toppner Carlsson E, Ahnmark A, Underwood CR, Rudvik A, Carter D, Laru J, Gutgsell A, Twaddle L, Garkaviy P, Bogstedt A, Hurt-Camejo E, Miliotis T, Ryaboshapkina M, Hober A, Hubbard B, Serrano-Wu M, Kaushik V, Geschwindner S, McCarthy MC, Linden D, Rosenmeier JB. Laroprovstat, the First Oral Small-Molecule PCSK9 Inhibitor for the Treatment of Hypercholesterolemia: Results From a Randomized, Single-Blind, Placebo-Controlled Phase 1 Trial in Treatment-Naive Patients. Circulation. 2026 Jun 23;153(25):1999-2010. doi: 10.1161/CIRCULATIONAHA.125.075973. Epub 2026 May 15.
PubMed 42137960
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Single-Blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD0780 Following Single and Multiple Ascending Dose Administration to Healthy Subjects With or Without Elevated LDL-C Levels
- ClinicalTrials.gov ID
- NCT05384262
- Acronym / sponsor ID
- D7960C00001
- Conditions
- Dyslipidemia
- Keywords
- Elevated LDL-C, Hypercholesterolemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 18 May 2022 (actual)
- Primary completion
- 14 Jun 2024 (actual)
- Study completion
- 14 Jun 2024 (actual)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD0780 following single and multiple dose administration to healthy subjects with or without elevated Low-Density Lipoprotein-Cholesterol (LDL-C) levels.
This study will consist of two parts (Parts A and B).
56 subjects have been planned for Part A and 141 subjects for Part B. Additional subjects may be included for the optional cohorts depending upon emerging data.
Detailed description
This is a Phase I, First In Human (FIH), randomized, single-blind, placebo-controlled, study in healthy male and/or female subjects of non-childbearing potential including healthy subjects of Chinese and Japanese ethnicity performed at multiple centers (up to 4 study centers).
56 subjects have been planned for Part A and 141 subjects for Part B.
- Part A:
- A Screening Period of maximum 28 days.
- Admission to study center (Day -1 or Day -2).
- A Treatment Period (Day 1 to Day 3) with a single dose of AZD0780 or placebo on Day 1. Subjects will be discharged on Day 3.
- A Follow-up Visit within 5 to 7 days after the Investigational Medicinal Product (IMP) dose for all cohorts.
- An additional Follow-up Visit within 9 to 11 days after the IMP dose from Cohort 3 onwards. (i) Part A1 - Up to 5 dose cohorts of AZD0780 are planned to be investigated. Depending on the findings, up to 4 additional dose cohorts may be added. Within each cohort, 6 subjects will be randomized to receive AZD0780, and 2 subjects randomized to receive placebo. Dosing for each ascending dose cohort will proceed with 2 subjects in a sentinel sub-cohort such that one subject will be randomized to receive AZD0780, and one subject will be randomized to receive placebo. (ii) Part A2 - The subjects from a chosen cohort in Part A1 will return to the study center no sooner than 9 days after the first dose administration of IMP and will receive AZD0780 or placebo after intake of a high-calorie, high-fat breakfast, to assess the effect of food on the PK of AZD0780.
The subjects will stay at the study center until 48 hours post-dose in both the parts.
- Part B:
- Global Multiple Ascending Dose (MAD) cohort - Up to 3 dose cohorts are planned to be investigated. In each cohort, 20 subjects will participate and receive either AZD0780 or placebo, randomized 3:1 for 28 days dosing. Depending on the findings, 3 additional dose levels may be added in up to 3 additional cohorts (up to 20 subjects per cohort).
- Japanese Single and Multiple Ascending Dose (JSMAD) cohorts - Two cohorts are planned. One cohort of 8 Japanese subjects will receive a medium dose level of AZD0780 or placebo randomized 3:1 for 9 days dosing (subjects will receive a single dose of IMP on Day 1 followed by daily dosing on Days 8 to 15 [there is no dose on Days 2 to 7]). The second cohort of 8 Japanese subjects will receive a higher dose level of AZD0780 or placebo.
- Rosuvastatin global MAD cohorts - Two cohorts are planned. Up to 40 subjects in the first cohort will receive either AZD0780 in combination with rosuvastatin or placebo in combination with rosuvastatin, randomized 1:1 to 1 of the 2 treatment arms with 20 subjects per arm. Up to 25 subjects will participate in the second cohort and will be randomized 4:1 to 1 of 2 treatment arms to receive either AZD0780 in combination with rosuvastatin (20 subjects) or placebo in combination with rosuvastatin (5 subjects). Subjects eligible for these cohorts will begin a Screening period of 56 days, a minimum of 21 days run-in period (maximum of up to 28 days), Treatment period of 28 days for each cohort and two Follow-up visits (1 \& 2 weeks after last dose of IMP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 14
- Model description
- This study will be a randomized, single-blind (study center staff including the Principal Investigator [PI] to remain blinded during the dosing phase of each cohort), placebo-controlled, Single Ascending Dose (SAD)/MAD, parallel type design in healthy male and/or female subjects, performed at multiple study centers.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Part A1 - AZD0780 dose 1/placebo tablet | Active comparator | Drug: AZD0780, Drug: PlaceboA 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 | Drug: AZD0780, Drug: PlaceboA 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 | Drug: AZD0780, Drug: PlaceboA 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 | Drug: AZD0780, Drug: PlaceboA 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 | Drug: AZD0780, Drug: PlaceboA 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 | Drug: AZD0780, Drug: PlaceboA 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 | Drug: AZD0780, Drug: PlaceboA 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 | Drug: AZD0780, Drug: PlaceboA 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 | Drug: AZD0780, Drug: PlaceboA 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 | Drug: AZD0780, Drug: PlaceboA 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 | Drug: AZD0780, Drug: PlaceboA 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 | Drug: AZD0780, Drug: RosuvastatinA total of 20 subjects will receive single dose of AZD0780 and rosuvastatin. |
| Cohort 13: Part B - placebo tablet/rosuvastatin dose 12 | Active comparator | Drug: Placebo, Drug: RosuvastatinA 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 | Drug: AZD0780, Drug: Placebo, Drug: RosuvastatinA total of 20 subjects will receive AZD0780 in combination with rosuvastatin or 5 subjects will receive placebo in combination with rosuvastatin. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Provision of signed and dated, written informed consent prior to any study specific procedures (including the Pre Screening Visit for Part B).
- Healthy male and female subjects (of nonchildbearing potential), aged 18 to 55 years inclusive, with suitable veins for cannulation or repeated venipuncture.
- Females must have a negative pregnancy test at the Screening Visit and on admission to the study center, must not be lactating and must be of non childbearing potential, confirmed at the Screening Visit by fulfilling one of the following criteria:
- Have a BMI between 18 and 35 kg/m2 inclusive and weigh at least 50 kg and no more than 120 kg inclusive at the Screening Visit and on admission to the study center.
- For Japanese subjects (Part B) and Chinese subjects (Part A):
Key exclusion criteria (26 listed)
- History of any clinically important disease or disorder.
- History or presence of gastrointestinal, hepatic or, renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
- Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) first vaccination within 30 days prior to randomization.
- SARS-CoV-2 second vaccination within 10 days of screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD0780Subjects will receive AZD0780 orally as a single ascending dose. | Drug | Cohort 11: Part A2 - AZD0780 dose 11/placebo tablet, Cohort 1: Part A1 - AZD0780 dose 1/placebo tablet, Cohort 2: Part A1 - AZD0780 dose 2/placebo tablet, Cohort 3: Part A1 - AZD0780 dose 3/placebo tablet, Cohort 4: Part A1 - AZD0780 dose 4/placebo tablet, Cohort 5: Part A1 - AZD0780 dose 5/placebo tablet |
| AZD0780Subjects will receive AZD0780 orally as a multiple ascending dose. | Drug | Cohort 12: Part B - AZD0780 dose 1/rosuvastatin dose 12, Cohort 14: Part B - AZD0780 with placebo tablet/AZD0780 with rosuvastatin dose 12, Cohort 6: Part B - AZD0780 dose 6/placebo tablet, Cohort 7: Part B - AZD0780 dose 7/placebo tablet, Cohort 8: Part B - AZD0780 dose 8/placebo tablet |
| AZD0780Subjects will receive AZD0780 orally as a single and multiple ascending dose. | Drug | Cohort 10: Part B - AZD0780 dose 10/placebo tablet, Cohort 9: Part B - AZD0780 dose 9/placebo tablet |
| PlaceboSubjects will receive placebo matching the AZD0780 dose orally as a single ascending dose. | Drug | Cohort 11: Part A2 - AZD0780 dose 11/placebo tablet, Cohort 1: Part A1 - AZD0780 dose 1/placebo tablet, Cohort 2: Part A1 - AZD0780 dose 2/placebo tablet, Cohort 3: Part A1 - AZD0780 dose 3/placebo tablet, Cohort 4: Part A1 - AZD0780 dose 4/placebo tablet, Cohort 5: Part A1 - AZD0780 dose 5/placebo tablet |
| PlaceboSubjects will receive placebo matching the AZD0780 dose orally as a multiple ascending dose. | Drug | Cohort 13: Part B - placebo tablet/rosuvastatin dose 12, Cohort 14: Part B - AZD0780 with placebo tablet/AZD0780 with rosuvastatin dose 12, Cohort 6: Part B - AZD0780 dose 6/placebo tablet, Cohort 7: Part B - AZD0780 dose 7/placebo tablet, Cohort 8: Part B - AZD0780 dose 8/placebo tablet |
| PlaceboSubjects will receive placebo matching the AZD0780 dose orally as a single and multiple ascending dose. | Drug | Cohort 10: Part B - AZD0780 dose 10/placebo tablet, Cohort 9: Part B - AZD0780 dose 9/placebo tablet |
| RosuvastatinSubjects will receive rosuvastatin orally. | Drug | Cohort 12: Part B - AZD0780 dose 1/rosuvastatin dose 12, Cohort 13: Part B - placebo tablet/rosuvastatin dose 12, Cohort 14: Part B - AZD0780 with placebo tablet/AZD0780 with rosuvastatin dose 12 |
Primary outcome
Number of subjects with Adverse Events
Time frame: 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.
9 secondary outcomes
Area under plasma concentration time curve from zero to infinity (AUCinf)
Time frame: SAD cohorts: Day 1-3 until 5-7 days (cohort 1 & 2) & 9-11 days (cohort 3 onwards) post-dose; JSMAD cohorts: Day 1-3,5,8,10,13,15,16 until 7-10 days post-dose; MAD Cohorts: Day 1 to 3,5,8,9,12,15,18,22,25,29 until Days 36, 43 [± 1day]
Area under plasma concentration time curve from zero to t hours post-dose (AUC[0-t])
Time frame: SAD cohorts: Day 1-3 until 5-7 days (cohort 1 & 2) & 9-11 days (cohort 3 onwards) post-dose; JSMAD cohorts: Day 1-3,5,8,10,13,15,16 until 7-10 days post-dose; MAD Cohorts: Day 1 to 3,5,8,9,12,15,18,22,25,29 until Days 36, 43 [± 1day]
Area under the plasma concentration-curve across the dosing interval (AUCτ)
Time frame: SAD cohorts: Day 1-3 until 5-7 days (cohort 1 & 2) & 9-11 days (cohort 3 onwards) post-dose; JSMAD cohorts: Day 1-3,5,8,10,13,15,16 until 7-10 days post-dose; MAD Cohorts: Day 1 to 3,5,8,9,12,15,18,22,25,29 until Days 36, 43 [± 1day]
Maximum observed plasma (peak) drug concentration [Cmax]
Time frame: SAD cohorts: Day 1-3 until 5-7 days (cohort 1 & 2) & 9-11 days (cohort 3 onwards) post-dose; JSMAD cohorts: Day 1-3,5,8,10,13,15,16 until 7-10 days post-dose; MAD Cohorts: Day 1 to 3,5,8,9,12,15,18,22,25,29 until Days 36, 43 [± 1day]
Amount of unchanged drug excreted into urine from zero to the last quantifiable concentration by interval and cumulatively (Ae[0-last])
Time frame: SAD cohorts (Parts A1 & A2): Day 1 to Day 3; JSMAD cohorts (Part B): Day 1 & 15; Global MAD Cohorts Day 1 & 10; Rosuvastatin Global MAD Cohorts (Part B): Day 1 & 8
Percentage of dose excreted unchanged in urine from zero to the last quantifiable concentration, by interval and cumulatively (fe[0-last])
Time frame: SAD cohorts (Parts A1 & A2): Day 1 to Day 3; JSMAD cohorts (Part B): Day 1 & 15; Global MAD Cohorts Day 1 & 10; Rosuvastatin Global MAD Cohorts (Part B): Day 1 & 8
Renal clearance of drug from plasma (CLR)
Time frame: SAD cohorts (Parts A1 & A2): Day 1 to Day 3; JSMAD cohorts (Part B): Day 1 & 15; Global MAD Cohorts Day 1 & 10; Rosuvastatin Global MAD Cohorts (Part B): Day 1 & 8
LDL-C
Time frame: LDL-C SAD cohorts: Days 1,2,3,5-7,9-11 LDL-C JSMAD cohorts: Days 1,2,3,10,15,16,17;LDL-C Global MAD Cohorts: Days 1,2,3,5,8,12,22, 25,29,36-43;LDL-C Rosuvastatin Global MAD Cohorts:Days -28,-8,-1,1,2,3,5,8,12,15,18,22,29,36-43
Proprotein convertase subtilisin/kexin type 9 (PCSK9)
Time frame: PCSK9 SAD cohorts: Days 1,2,3;PCSK9 JSMAD cohorts:Days 1,2,3,10,15,16,17,22-25;PCSK9 Global MAD Cohorts:Days 1,8,15,22,29,36-43; PCSK9 Rosuvastatin Global MAD Cohorts:Days 1,8,15,22,29,36-43
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Derived from this study: PubMed 42137960Vega RB, O'Mahony G, Barbour AM, Yu H, Knochel J, Brengdahl J, Hochdorfer T, Bergenholm L, Toppner Carlsson E, Ahnmark A, Underwood CR, Rudvik A, Carter D, Laru J, Gutgsell A, Twaddle L, Garkaviy P, Bogstedt A, Hurt-Camejo E, Miliotis T, Ryaboshapkina M, Hober A, Hubbard B, Serrano-Wu M, Kaushik V, Geschwindner S, McCarthy MC, Linden D, Rosenmeier JB. Laroprovstat, the First Oral Small-Molecule PCSK9 Inhibitor for the Treatment of Hypercholesterolemia: Results From a Randomized, Single-Blind, Placebo-Controlled Phase 1 Trial in Treatment-Naive Patients. Circulation. 2026 Jun 23;153(25):1999-2010. doi: 10.1161/CIRCULATIONAHA.125.075973. Epub 2026 May 15.
- redacted CSR SynopsisLink provided by the sponsor.
- Results of this clinical trial are available on www.astrazenecaclinicaltrials.comLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD0780 and Rosuvastatin in people with Dyslipidemia, run by AstraZeneca at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with Adverse Events (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05384262, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.