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DyslipidemiaPhase 1NCT06742853

A Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of AZD0780 With Ezetimibe Combinations in Healthy Adults With Elevated LDL-C.

A Phase 1 study testing AZD0780, Ezetimibe and Rosuvastatin in people with Dyslipidemia, run by AstraZeneca at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main aim of this study is to assess the effects of AZD0780 when added on top of ezetimibe or ezetimibe and rosuvastatin or ezetimibe and bempedoic acid. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Dyslipidemia
What is being tested?
AZD0780, Ezetimibe and Rosuvastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
81 participants
Where
3 sitesin 2 countries
Study dates
20 Dec 2024to 29 Oct 2025
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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Signed the informed consent form before any study-related procedure.
  • All females must have a negative serum pregnancy test at the Screening Visit and on admission to the Clinical Unit
  • Females of non-childbearing potential must be confirmed at the Screening Visit by fulfilling one of the following criteria: postmenopausal or surgically sterilized females.
  • Have a Body Mass Index (BMI) > 18 kg/m² and weigh at least 50 kg.
  • Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
  • Fasting LDL-C > 100 mg/dL but < 190 mg/dL (> 2.6 mmol/L but < 4.9 mmol/L for London EPCU) at the Screening Visit.
  • Fasting triglycerides < 400 mg/dL (or < 10.3 mmol/L for London EPCU) at the Screening Visit.

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 study intervention.
  • Any laboratory values with specific deviations in alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin (TBL), estimated glomerular filtration rate, or hemoglobin at the Screening Visit or on Admission
  • Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results other than those described under exclusion criterion number 4, at Screening and/or Admission to the Clinical Unit
  • Any positive result on Screening for serum HBsAg, hepatitis B core antibody or human immunodeficiency virus.
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  • History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD0780, ezetimibe, rosuvastatin, and bempedoic acid.
  • Treatment with any lipid-lowering therapy or AZD0780 within the 3 months prior to Screening.
  • Treatment with drugs for reduction or inhibition of Proprotein convertase subtilisin/kexin type 9 (PCSK9) within the last 12 months prior to Screening (approved or investigational and apart from AZD0780).

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

Other trials in United States

United Kingdom1 site

  • Research Site

    Harrow, HA1 3UJ

Other trials in United Kingdom

About this study

Official title: A Phase 1, Randomized, Single-blind, Placebo-controlled Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of AZD0780 in Combination With Ezetimibe, Ezetimibe/Rosuvastatin, or Ezetimibe/Bempedoic Acid in Healthy Male and Female Participants 18 to 75 Years of Age With Elevated LDL-C.

The main aim of this study is to assess the effects of AZD0780 when added on top of ezetimibe or ezetimibe and rosuvastatin or ezetimibe and bempedoic acid.

Read the detailed description

This is a randomized, single-blind, placebo-controlled study in healthy participants with elevated low-density lipoprotein-cholesterol (LDL-C).

This study will assess the pharmacokinetic (PK), safety, tolerability, and efficacy of AZD0780 in combination with ezetimibe, ezetimibe/rosuvastatin, and ezetimibe/bempedoic acid.

Participants will be randomized to receive either AZD0780 or placebo (to be administered with ezetimibe, ezetimibe/rosuvastatin, or ezetimibe/bempedoic acid).

The study will comprise:

  1. A Screening Period of up to 28 days.
  2. A Run-in Period of 28 days.
  3. A Treatment Period of 28 days.
  4. Two Follow-up Visits, one and two weeks after the last dose of study drug.
Conditions
Dyslipidemia
Being tested
AZD0780, Ezetimibe, Rosuvastatin, Bempedoic Acid, Placebo
Keywords
LDL-C, Hypercholesterolemia, Cholesterol absorption inhibitor, ATP-citrate lyase inhibitor
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

    AZD0780 tablet will be administered orally.

  • EzetimibeDrug

    Ezetimibe tablet will be administered orally.

  • RosuvastatinDrug

    Rosuvastatin tablet will be administered orally.

  • Bempedoic AcidDrug

    Bempedoic Acid tablet will be administered orally.

  • PlaceboDrug

    Placebo will be administered orally.

Study groups in NCT06742853
Study groupRoleWhat they receive
Ezetimibe + AZD0780ExperimentalParticipants will receive ezetimibe 10 mg and AZD0780 once daily (QD) for 4 weeks.
Receives: Drug: AZD0780; Drug: Ezetimibe
Rosuvastatin + Ezetimibe + AZD0780ExperimentalParticipants will receive rosuvastatin 20 mg, ezetimibe 10 mg and AZD0780 QD for 4 weeks.
Receives: Drug: AZD0780; Drug: Ezetimibe; Drug: Rosuvastatin
Bempedoic Acid + Ezetimibe + AZD0780 (Optional Cohort)ExperimentalParticipants will receive bempedoic acid 180 mg, ezetimibe 10 mg and AZD0780 QD for 4 weeks.
Receives: Drug: AZD0780; Drug: Ezetimibe; Drug: Bempedoic Acid
Ezetimibe + PlaceboPlacebo comparatorParticipants will receive ezetimibe 10 mg and placebo QD for 4 weeks.
Receives: Drug: Ezetimibe; Drug: Placebo
Rosuvastatin + Ezetimibe + PlaceboPlacebo comparatorParticipants will receive rosuvastatin 20 mg, ezetimibe 10 mg and placebo QD for 4 weeks.
Receives: Drug: Ezetimibe; Drug: Rosuvastatin; Drug: Placebo
Bempedoic Acid + Ezetimibe + Placebo (Optional Cohort)Placebo comparatorParticipants will receive bempedoic acid 180 mg, ezetimibe 10 mg and placebo QD for 4 weeks.
Receives: Drug: Ezetimibe; Drug: Bempedoic Acid; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in direct Low-density Lipsprotein Cholesterol (LDL-C)

    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.

    Measured: Week 4

  2. Number of participants with adverse events

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

    Measured: From screening (Day -56 to -29) to 14 Weeks

Secondary outcomes (13)

  1. Plasma concentration of AZD0780

    To further characterize AZD0780 pharmacokinetics (PK) in plasma.

    Measured: From Day 1 to Day 42

  2. Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)

    To further characterize AZD0780 PK in plasma.

    Measured: From Day 1 to Day 42

  3. Area under concentration-time curve in the dosing interval (AUCtau) (Day 15)

    To further characterize AZD0780 PK in plasma.

    Measured: From Day 1 to Day 42

  4. Maximum observed drug concentration (Cmax)

    To further characterize AZD0780 PK in plasma.

    Measured: From Day 1 to Day 42

  5. Time to reach maximum observed concentration (tmax)

    To further characterize AZD0780 PK in plasma.

    Measured: From Day 1 to Day 42

  6. Change from baseline in LDL-C ultra

    To evaluate the effect of AZD0780 on lipid parameters and inflammatory markers versus placebo when dosed with ezetimibe or ezetimibe and rosuvastatin or ezetimibe and bempedoic acid.

    Measured: Week 4

  7. Change from baseline in LDL-C Friedewald

    To evaluate the effect of AZD0780 on lipid parameters and inflammatory markers versus placebo when dosed with ezetimibe or ezetimibe and rosuvastatin or ezetimibe and bempedoic acid.

    Measured: Week 4

  8. Change from baseline in total cholesterol

    To evaluate the effect of AZD0780 on lipid parameters and inflammatory markers versus placebo when dosed with ezetimibe or ezetimibe and rosuvastatin or ezetimibe and bempedoic acid.

    Measured: Week 4

  9. Change from baseline in non- HDL-C (high-density lipoprotein-cholesterol)

    To evaluate the effect of AZD0780 on lipid parameters and inflammatory markers versus placebo when dosed with ezetimibe or ezetimibe and rosuvastatin or ezetimibe and bempedoic acid.

    Measured: Week 4

  10. Change from baseline in HDL-C

    To evaluate the effect of AZD0780 on lipid parameters and inflammatory markers versus placebo when dosed with ezetimibe or ezetimibe and rosuvastatin or ezetimibe and bempedoic acid.

    Measured: Week 4

  11. Change from baseline in triglycerides

    To evaluate the effect of AZD0780 on lipid parameters and inflammatory markers versus placebo when dosed with ezetimibe or ezetimibe and rosuvastatin or ezetimibe and bempedoic acid.

    Measured: Week 4

  12. Change from baseline in in Lipoprotein A [Lp(a)]

    To evaluate the effect of AZD0780 on lipid parameters and inflammatory markers versus placebo when dosed with ezetimibe or ezetimibe and rosuvastatin or ezetimibe and bempedoic acid.

    Measured: Week 4

  13. Change from baseline in Apolipoprotein B (ApoB)

    To evaluate the effect of AZD0780 on lipid parameters and inflammatory markers versus placebo when dosed with ezetimibe or ezetimibe and rosuvastatin or ezetimibe and bempedoic acid.

    Measured: Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2024
  2. Study start20 Dec 2024
  3. Primary completion29 Oct 2025
  4. Study completion29 Oct 2025

Resources

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
Masking
Single blind
Who is masked
Participant
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06742853
Sponsor's protocol ID
D7960C00017
Status last verified
Nov 2025
First submitted
16 Dec 2024
Last updated
10 Nov 2025
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 Vivli.org. All requests 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 approved.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AZD0780, Ezetimibe 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 7 inclusion and 9 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 10 Nov 2025. 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. Some participants in this study may receive a placebo. 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?

Change from baseline in direct Low-density Lipsprotein Cholesterol (LDL-C) (time frame: Week 4). The study lists 2 primary outcomes in all. 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 NCT06742853.

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 10 Nov 2025.

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