Healthy ParticipantsPhase 1NCT07423598
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics With AZD0780 Following Repeated Dose Administration in Healthy Adults With Elevated LDL-C Levels
A Phase 1 study testing AZD0780 in people with Healthy Participants, run by AstraZeneca at 1 site in United States.
Trial summary
The purpose of this study is to evaluate pharmacodynamics (PD) of AZD0780 compared with placebo by assessment of low-density lipoprotein-cholesterol (LDL-C) levels following repeated oral dosing in healthy adults with elevated LDL-C levels. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- AZD0780
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2026to 29 Jun 2026
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy participants with suitable veins for cannulation or repeated venipuncture.
- All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
- Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception.
- Females of non-childbearing potential must be confirmed as postmenopausal or have documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation or tubal occlusion.
- Have a body mass index between 18 and 35 kg/m2 inclusive and weigh at least 50 kg.
- Fasting LDL-C ≥ 70 mg/dL and < 190 mg/dL at Screening.
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.
- Any abnormal vital signs or laboratory values including clinical chemistry, hematology, coagulation, or urinalysis results.
- Current smokers or those who have smoked or used nicotine products (including e-cigarettes) or any known or suspected history of alcohol or drug abuse.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, especially to drugs with a similar chemical structure or class to AZD0780.
Trial locations and contacts
1 site in 1 country.
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 Repeated Dose Administration to Healthy Adults With Elevated LDL-C Levels
The purpose of this study is to evaluate pharmacodynamics (PD) of AZD0780 compared with placebo by assessment of low-density lipoprotein-cholesterol (LDL-C) levels following repeated oral dosing in healthy adults with elevated LDL-C levels.
Read the detailed description
This is a Phase I, randomized, single-blind, placebo-controlled study of AZD0780 in healthy adults with elevated LDL-C levels.
The study comprises of:
- An optional Pre-screening visit.
- A Screening Period (maximum 28 days).
- Admission to the Clinical Unit (Day -1).
- A Treatment Period for administration of AZD0780 or placebo (Days 1 to 28).
- Follow-up Visit 12 ± 2 days after the last study intervention dose.
- Conditions
- Healthy Participants
- Being tested
- AZD0780, Placebo
- Keywords
- Pharmacokinetics, Pharmacodynamics, Repeated dosing, Dyslipidemia, Elevated low-density lipoprotein cholesterol
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD0780Drug
AZD0780 will be administered orally.
PlaceboDrug
Placebo will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| AZD0780 | Experimental | Participants will receive a dose of AZD0780. Receives: Drug: AZD0780 |
| Placebo | Placebo comparator | Participants will receive a dose of matching placebo to AZD0780 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change from baseline in LDL-C levels
To determine the pharmacodynamic profile of AZD0780 versus placebo by evaluating LDL-C concentrations after repeated oral administration
Measured: From Baseline (Day 1) to 4 weeks
Secondary outcomes (4)
Area under concentration-time curve from time 0 to infinity (AUCinf)
To characterize the single dose and steady state pharmacokinetics (PK) of AZD0780 following oral administration of AZD0780
Measured: At pre-defined intervals from Day 1 to Day 40
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
To characterize the single dose and steady state PK of AZD0780 following oral administration of AZD0780
Measured: At pre-defined intervals from Day 1 to Day 40
Maximum observed drug concentration (Cmax)
To characterize the single dose and steady state PK of AZD0780 following oral administration of AZD0780
Measured: At pre-defined intervals from Day 1 to Day 40
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
To assess the safety and tolerability of AZD0780 versus placebo following oral administration of repeated dosing in healthy participants
Measured: Upto Day 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start24 Feb 2026
- Primary completion29 Jun 2026
- Study completion29 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 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
- NCT07423598
- Sponsor's protocol ID
- D7960C00021
- Status last verified
- Jul 2026
- First submitted
- 13 Feb 2026
- Last updated
- 7 Jul 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 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 shared.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 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 Repeated Dose Administration to Healthy Adults With Elevated LDL-C Levels
- ClinicalTrials.gov ID
- NCT07423598
- Acronym / sponsor ID
- D7960C00021
- Conditions
- Healthy Participants
- Keywords
- Pharmacokinetics, Pharmacodynamics, Repeated dosing, Dyslipidemia, Elevated low-density lipoprotein cholesterol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- 29 Jun 2026 (actual)
- Study completion
- 29 Jun 2026 (actual)
- First posted
- 20 Feb 2026 (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.
The purpose of this study is to evaluate pharmacodynamics (PD) of AZD0780 compared with placebo by assessment of low-density lipoprotein-cholesterol (LDL-C) levels following repeated oral dosing in healthy adults with elevated LDL-C levels.
Detailed description
This is a Phase I, randomized, single-blind, placebo-controlled study of AZD0780 in healthy adults with elevated LDL-C levels.
The study comprises of:
- An optional Pre-screening visit.
- A Screening Period (maximum 28 days).
- Admission to the Clinical Unit (Day -1).
- A Treatment Period for administration of AZD0780 or placebo (Days 1 to 28).
- Follow-up Visit 12 ± 2 days after the last study intervention dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZD0780 | Experimental | Drug: AZD0780Participants will receive a dose of AZD0780. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a dose of matching placebo to AZD0780 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy participants with suitable veins for cannulation or repeated venipuncture.
- All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
- Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception.
- Females of non-childbearing potential must be confirmed as postmenopausal or have documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation or tubal occlusion.
- Have a body mass index between 18 and 35 kg/m2 inclusive and weigh at least 50 kg.
Key exclusion criteria (6 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.
- Any abnormal vital signs or laboratory values including clinical chemistry, hematology, coagulation, or urinalysis results.
- Current smokers or those who have smoked or used nicotine products (including e-cigarettes) or any known or suspected history of alcohol or drug abuse.
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 |
|---|---|---|
| AZD0780AZD0780 will be administered orally. | Drug | AZD0780 |
| PlaceboPlacebo will be administered orally. | Drug | Placebo |
Primary outcome
Relative change from baseline in LDL-C levels
Time frame: 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
4 secondary outcomes
Area under concentration-time curve from time 0 to infinity (AUCinf)
Time frame: At pre-defined intervals from Day 1 to Day 40
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
Time frame: At pre-defined intervals from Day 1 to Day 40
Maximum observed drug concentration (Cmax)
Time frame: At pre-defined intervals from Day 1 to Day 40
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: Upto Day 40
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 7 Jul 2026.
- 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 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 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD0780 in people with Healthy Participants, run by AstraZeneca at 1 site in United States.
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 6 inclusion and 6 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 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Relative change from baseline in LDL-C levels (time frame: From Baseline (Day 1) to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2026.