Healthy ParticipantsPhase 1NCT06980428
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4954 in Healthy Adult Participants With or Without Elevated Lipoprotein (a) (Lp[a]) Levels, and Participants With Dyslipidemia
A Phase 1 study testing AZD4954 in people with Healthy Participants and Dyslipidemia, run by AstraZeneca at 6 sites in United States.
Trial summary
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of AZD4954 in healthy participants with or without elevated Lipoprotein(a) (Lp[a]) levels and participants with dyslipidemia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Healthy Participants, Dyslipidemia
- What is being tested?
- AZD4954
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 171 participants
- Where
- 6 sitesUnited States
- Study dates
- 27 May 2025to 9 Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All Parts:
- Participants with plasminogen level (concentration) within normal range at the Screening Visit.
- All females must have a negative pregnancy test at the Screening Visit and on admission to the study site.
- 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 at the Screening Visit.
- Sexually active fertile male participants with partners of childbearing potential must adhere to the study specific contraception methods from the time of first administration of study intervention until 3 months after the study Follow-up Visit.
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- Parts A and B (Healthy Participants):
- Male and female participants aged 18 to 65 years with suitable veins for cannulation or repeated venipuncture.
- Have a body mass index (BMI) between 18 and 35 kg/m² inclusive.
- For Japanese and Chinese participants (Parts A and B):
- A Japanese participant is defined as having both parents and 4 grandparents who are ethnically Japanese. This includes second and third generation Japanese whose parents or grandparents are living in a country other than Japan.
- A Chinese participant is defined as having both parents and 4 grandparents who are ethnically Chinese. This includes second and third generation Chinese whose parents or grandparents are living in a country other than China.
- Part B (Healthy Participants):
- Participants must have elevated Lp(a) ≥ 30 mg/dL (62 nmol/L) at the Screening Visit.
- Part B (Participants with Dyslipidemia):
- Male and female participants aged 18 to 70 years with suitable veins for cannulation or repeated venipuncture.
- Have a BMI > 18 kg/m².
- Participants must have elevated Lp(a) ≥ 70 mg/dL (150 nmol/L) at the Screening Visit.
- Participants with a fasting LDL-C ≥ 70 mg/dL and < 190 mg/L at the Screening Visit.
- Participants should be receiving moderate or high-intensity statin therapy for ≥ 2 months prior to the Screening Visit, according to the American College of Cardiology/American Heart Association guidelines on blood cholesterol management.
- Participants with documented coronary artery disease, stroke, or peripheral artery disease or at moderate or high risk for an atherosclerotic cardiovascular disease event.
- There should be no planned medication or dose change during study participation.
Who cannot join
- All Parts:
- 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.
- Participants with known bleeding or coagulation disorders.
- Participants who have an elevated high-sensitivity C-reactive protein (> 3 mg/L) or have a prothrombin time/international normalized ratio (PT/INR) or activated partial thromboplastin time (aPTT) > 1.25 times × upper limit normal (ULN).
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- Any clinically important abnormalities in hematology, coagulation, clinical chemistry, urinalysis, abnormal vital signs or abnormal laboratory values.
- Any positive result on Screening for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
- Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead electrocardiogram (ECG) at Screening.
- Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeks prior to the first administration of study intervention.
- Parts A and B (Healthy Participants):
- Use of any prescribed or nonprescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, intake of > 3 × daily recommended levels of vitamins and minerals during the 2 weeks prior to the first administration of study intervention or longer if the medication has a long half-life.
- Current smokers or those who have smoked or used nicotine products.
- Part B (Participants with Dyslipidemia):
- Acute ischemic cardiovascular event in the last 12 months prior to randomization.
- Poorly controlled diabetes.
- Previous administration of Lp(a) inhibitor.
- Have uncontrolled hypertension.
- Abnormal vital heart rate.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Research Site
Brooklyn, Maryland, 21225
- Recruiting
Research Site
Glendale, California, 91206
- Recruiting
Research Site
Inverness, Florida, 34452
- Recruiting
Research Site
Jacksonville, Florida, 32216
- Recruiting
Research Site
Port Orange, Florida, 32127
- Recruiting
Research Site
San Antonio, Texas, 78229
About this study
Official title: A Phase I, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4954 Following Single and Multiple Ascending Dose Administration to Healthy Participants With or Without Elevated Lp(a) Levels, and Participants With Dyslipidemia
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of AZD4954 in healthy participants with or without elevated Lipoprotein(a) (Lp[a]) levels and participants with dyslipidemia.
Read the detailed description
This is a first time in human, placebo-controlled, single and multiple ascending dose (SAD and MAD) study in healthy male and female participants (Part A) or healthy participants with elevated Lp(a) levels (≥ 30 mg/dL, [62 nmol/L]) and participants with dyslipidemia with elevated Lp(a) levels (≥ 70 mg/dL, [150 nmol/L]) and low-density lipoprotein cholesterol (LDL-C) ≥ 70 mg/dL and < 190 mg/dL (Part B).
The study consists of 2 parts: Part A (SAD) and Part B (MAD).
Part A of the study will consist of Part A1 and Part A2, comprising:
- A Screening Period of maximum 28 days.
- Admission to study site (Day -1).
- A Treatment Period (Day 1 to Day 15 at the study site) with a single dose of AZD4954 or placebo on Day 1.
- A Follow-up Visit within 26 to 30 days after the study intervention dose for all cohorts (Day 29 ±2 days).
Part B has 3 types of MAD cohorts - global cohorts with healthy participants, global cohort with participants with dyslipidemia, and a Japanese cohort. The global MAD cohorts (healthy participants) and Japanese MAD cohort will comprise:
- A Screening Period of maximum 28 days.
- Admission to study site (Day -1).
- A Treatment Period during which participants will receive either AZD4954 or placebo once daily for 21 days (Day 1 to 21).
- A Follow-up Visit within 26 to 30 days after the last study intervention dose (Day 49 ±2 days).
The global MAD cohort (participants with dyslipidemia) will comprise:
- A Screening Period of maximum 28 days.
- Residential study site visits from Day -1 to Day 2 and Day 21 to Day 22.
- Non-residential study site visits on Day 8 and Day 15.
- A Treatment Period during which participants will receive either AZD4954 or placebo once daily for 21 days (Day 1 to 21).
- A Follow-up Visit within 26 to 30 days after the last study intervention dose (Day 49 ± 2 days).
- Conditions
- Healthy Participants, Dyslipidemia
- Being tested
- AZD4954, Placebo
- Keywords
- Lipoprotein(a), Low-density lipoprotein cholesterol (LDL-C)
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD4954Drug
AZD4954 will be administered orally.
PlaceboDrug
Placebo will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Part A1: SAD Cohort 1 - AZD4954 (Dose 1) | Experimental | Participants will receive a single dose of AZD4954 (Dose 1) or matching placebo on Day 1. Receives: Drug: AZD4954; Drug: Placebo |
| Part A1: SAD Cohort 2 - AZD4954 (Dose 2) | Experimental | Participants will receive a single dose of AZD4954 (Dose 2) or matching placebo on Day 1. Receives: Drug: AZD4954; Drug: Placebo |
| Part A1: SAD Cohort 3 - AZD4954 (Dose 3) | Experimental | Participants will receive a single dose of AZD4954 (Dose 3) or matching placebo on Day 1. Receives: Drug: AZD4954; Drug: Placebo |
| Part A1: SAD Cohort 4 - AZD4954 (Dose 4) | Experimental | Participants will receive a single dose of AZD4954 (Dose 4) or matching placebo on Day 1. Receives: Drug: AZD4954; Drug: Placebo |
| Part A1: SAD Cohort 5 - AZD4954 (Dose 5) | Experimental | Participants will receive a single dose of AZD4954 (Dose 5) or matching placebo on Day 1. Receives: Drug: AZD4954; Drug: Placebo |
| Part A1: SAD Optional Cohort 6 - AZD4954 | Experimental | This additional cohort may be added depending on the findings. Receives: Drug: AZD4954; Drug: Placebo |
| Part A1: SAD Cohort 1 (Japanese) - AZD4954 (Dose 2) | Experimental | Japanese participants will receive a single dose of AZD4954 (Dose 2) or matching placebo on Day 1. Receives: Drug: AZD4954; Drug: Placebo |
| Part A1: SAD Cohort 2 (Japanese) - AZD4954 (Dose 3) | Experimental | Japanese participants will receive a single dose of AZD4954 (Dose 3) or matching placebo on Day 1. Receives: Drug: AZD4954; Drug: Placebo |
| Part A1: SAD Optional Cohort 3 (Japanese) - AZD4954 | Experimental | This additional cohort may be added depending on the findings. Receives: Drug: AZD4954; Drug: Placebo |
| Part A1: SAD Cohort 1 (Chinese) - AZD4954 (Dose 5) | Experimental | Chinese participants will receive a single dose of AZD4954 (Dose 5) or matching placebo at the highest dose level on Day 1. Receives: Drug: AZD4954; Drug: Placebo |
| Part A2: SAD Food Effect Cohort - AZD4954 (Dose 2) | Experimental | Participants will receive a single dose of AZD4954 (Dose 2) or matching placebo with a high-calorie, high-fat breakfast on Day 1. Receives: Drug: AZD4954; Drug: Placebo |
| Part A2: SAD Food Effect Cohort - AZD4954 (Dose 3) | Experimental | Participants will receive a single dose of AZD4954 (Dose 3) or matching placebo with a high-calorie, high-fat breakfast on Day 1. Receives: Drug: AZD4954; Drug: Placebo |
| Part B: Global MAD Cohort 1 (healthy participants) - AZD4954 (Dose 1) | Experimental | Participants will receive multiple doses of AZD4954 (Dose 1) or matching placebo for 21 days. Receives: Drug: AZD4954; Drug: Placebo |
| Part B: Global MAD Cohort 2 (healthy participants) - AZD4954 (Dose 2) | Experimental | Participants will receive multiple doses of AZD4954 (Dose 2) or matching placebo for 21 days. Receives: Drug: AZD4954; Drug: Placebo |
| Part B: Global MAD Cohort 3 (healthy participants) - AZD4954 (Dose 3) | Experimental | Participants will receive multiple doses of AZD4954 (Dose 3) or matching placebo for 21 days. Receives: Drug: AZD4954; Drug: Placebo |
| Part B: Optional Global MAD Cohort 4 (healthy participants) - AZD4954 | Experimental | Participants will receive multiple doses of AZD4954 or matching placebo for 21 days. This additional cohort may be added depending on the findings. Receives: Drug: AZD4954; Drug: Placebo |
| Part B: Optional Global MAD Cohort 5 (healthy participants) - AZD4954 | Experimental | Participants will receive multiple doses of AZD4954 or matching placebo for 21 days. This additional cohort may be added depending on the findings. Receives: Drug: AZD4954; Drug: Placebo |
| Part B: Optional Global MAD Cohort 6 (healthy participants) - AZD4954 | Experimental | Participants will receive multiple doses of AZD4954 or matching placebo for 21 days. This additional cohort may be added depending on the findings. Receives: Drug: AZD4954; Drug: Placebo |
| Part B: MAD Cohort (Japanese) - AZD4954 (Dose 3) | Experimental | Japanese participants will receive multiple doses of AZD4954 (Dose 3) or matching placebo for 21 days. Receives: Drug: AZD4954; Drug: Placebo |
| Part B: Global MAD Cohort (participants with dyslipidemia) - AZD4954 (Dose 6) | Experimental | Participants with dyslipidemia will receive multiple doses of AZD4954 (Dose 6) or matching placebo for 21 days. Receives: Drug: AZD4954; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
To assess the safety and tolerability of AZD4954 following oral administration of SAD (Part A).
Measured: From Screening (Day -28 to Day -2) to Follow-up visit (Up to Day 29±2 days)
Part B: Number of participants with AEs and SAEs
To assess the safety and tolerability of AZD4954 following oral administration of MAD (Part B).
Measured: From Screening (Day -28 to Day -2) to Follow-up visit (Up to Day 49±2 days)
Secondary outcomes (21)
Part A: Area under concentration-time curve from time 0 to infinity (AUCinf)
To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954.
Measured: Up to Day 29±2 days
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954.
Measured: Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days
Part B: Area under concentration-time curve in the dosing interval (AUCtau)
To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954.
Measured: Up to Day 49±2 days
Dose normalized AUClast (AUClast/D)
To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954.
Measured: Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days
Dose normalized AUCinf (AUCinf/D)
To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954.
Measured: Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days
Part B: Dose normalized AUCtau (AUCtau/D)
To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954.
Measured: Up to Day 49±2 days
Apparent total body clearance (CL/F)
To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954.
Measured: Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days
Maximum observed drug concentration (Cmax)
To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954.
Measured: Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days
Dose normalized Cmax (Cmax/D)
To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954.
Measured: Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days
Terminal elimination half-life (t1/2λz)
To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954.
Measured: Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days
Time of last quantifiable concentration (tlast)
To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954.
Measured: Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days
Time to reach maximum observed concentration (tmax)
To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954.
Measured: Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days
Apparent volume of distribution based on the terminal phase (Vz/F)
To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954.
Measured: Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days
Individual and cumulative amount of unchanged drug excreted into urine from time t1 to time t2 (Ae[t1-t2])
To characterize the single dose and/or steady state urine pharmacokinetics of AZD4954 following oral administration of AZD4954.
Measured: Part A: Up to Day 15; Part B: Up to Day 22
Cumulative amount of unchanged drug excreted into urine (Aeinf)
To characterize the single dose and/or steady state urine pharmacokinetics of AZD4954 following oral administration of AZD4954.
Measured: Part A: Up to Day 15; Part B: Up to Day 22
Individual and cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 (fe[t1-t2])
To characterize the single dose and/or steady state urine pharmacokinetics of AZD4954 following oral administration of AZD4954.
Measured: Part A: Up to Day 15; Part B: Up to Day 22
Renal clearance (CLR)
To characterize the single dose and/or steady state urine pharmacokinetics of AZD4954 following oral administration of AZD4954.
Measured: Part A: Up to Day 15; Part B: Up to Day 22
Part B: Absolute change from baseline in serum Lp(a)
To evaluate the pharmacodynamics of AZD4954 by assessment of Lp(a) levels following repeated oral dosing.
Measured: Up to Day 49±2 days
Part B: Relative change from baseline in serum Lp(a)
To evaluate the pharmacodynamics of AZD4954 by assessment of Lp(a) levels following repeated oral dosing.
Measured: Up to Day 49±2 days
Part B: Absolute change from baseline in Lp(a) intact assay
To evaluate the pharmacodynamics of AZD4954 by assessment of Lp(a) levels following repeated oral dosing.
Measured: Up to Day 49±2 days
Part B: Relative change from baseline in Lp(a) intact assay
To evaluate the pharmacodynamics of AZD4954 by assessment of Lp(a) levels following repeated oral dosing.
Measured: Up to Day 49±2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start27 May 2025
- Primary completion9 Apr 2027 (estimated)
- Study completion9 Apr 2027 (estimated)
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
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 171 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980428
- Sponsor's protocol ID
- D7300C00001
- Status last verified
- Oct 2026
- First submitted
- 19 May 2025
- Last updated
- 2 Nov 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 2 Nov 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 AZD4954 Following Single and Multiple Ascending Dose Administration to Healthy Participants With or Without Elevated Lp(a) Levels, and Participants With Dyslipidemia
- ClinicalTrials.gov ID
- NCT06980428
- Acronym / sponsor ID
- D7300C00001
- Conditions
- Healthy Participants, Dyslipidemia
- Keywords
- Lipoprotein(a), Low-density lipoprotein cholesterol (LDL-C)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 171 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 27 May 2025 (actual)
- Primary completion
- 9 Apr 2027 (estimated)
- Study completion
- 9 Apr 2027 (estimated)
- First posted
- 20 May 2025 (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 the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of AZD4954 in healthy participants with or without elevated Lipoprotein(a) (Lp[a]) levels and participants with dyslipidemia.
Detailed description
This is a first time in human, placebo-controlled, single and multiple ascending dose (SAD and MAD) study in healthy male and female participants (Part A) or healthy participants with elevated Lp(a) levels (≥ 30 mg/dL, [62 nmol/L]) and participants with dyslipidemia with elevated Lp(a) levels (≥ 70 mg/dL, [150 nmol/L]) and low-density lipoprotein cholesterol (LDL-C) ≥ 70 mg/dL and < 190 mg/dL (Part B).
The study consists of 2 parts: Part A (SAD) and Part B (MAD).
Part A of the study will consist of Part A1 and Part A2, comprising:
- A Screening Period of maximum 28 days.
- Admission to study site (Day -1).
- A Treatment Period (Day 1 to Day 15 at the study site) with a single dose of AZD4954 or placebo on Day 1.
- A Follow-up Visit within 26 to 30 days after the study intervention dose for all cohorts (Day 29 ±2 days).
Part B has 3 types of MAD cohorts - global cohorts with healthy participants, global cohort with participants with dyslipidemia, and a Japanese cohort. The global MAD cohorts (healthy participants) and Japanese MAD cohort will comprise:
- A Screening Period of maximum 28 days.
- Admission to study site (Day -1).
- A Treatment Period during which participants will receive either AZD4954 or placebo once daily for 21 days (Day 1 to 21).
- A Follow-up Visit within 26 to 30 days after the last study intervention dose (Day 49 ±2 days).
The global MAD cohort (participants with dyslipidemia) will comprise:
- A Screening Period of maximum 28 days.
- Residential study site visits from Day -1 to Day 2 and Day 21 to Day 22.
- Non-residential study site visits on Day 8 and Day 15.
- A Treatment Period during which participants will receive either AZD4954 or placebo once daily for 21 days (Day 1 to 21).
- A Follow-up Visit within 26 to 30 days after the last study intervention dose (Day 49 ± 2 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 20
| Arm | Type | Receives |
|---|---|---|
| Part A1: SAD Cohort 1 - AZD4954 (Dose 1) | Experimental | Drug: AZD4954, Drug: PlaceboParticipants will receive a single dose of AZD4954 (Dose 1) or matching placebo on Day 1. |
| Part A1: SAD Cohort 2 - AZD4954 (Dose 2) | Experimental | Drug: AZD4954, Drug: PlaceboParticipants will receive a single dose of AZD4954 (Dose 2) or matching placebo on Day 1. |
| Part A1: SAD Cohort 3 - AZD4954 (Dose 3) | Experimental | Drug: AZD4954, Drug: PlaceboParticipants will receive a single dose of AZD4954 (Dose 3) or matching placebo on Day 1. |
| Part A1: SAD Cohort 4 - AZD4954 (Dose 4) | Experimental | Drug: AZD4954, Drug: PlaceboParticipants will receive a single dose of AZD4954 (Dose 4) or matching placebo on Day 1. |
| Part A1: SAD Cohort 5 - AZD4954 (Dose 5) | Experimental | Drug: AZD4954, Drug: PlaceboParticipants will receive a single dose of AZD4954 (Dose 5) or matching placebo on Day 1. |
| Part A1: SAD Optional Cohort 6 - AZD4954 | Experimental | Drug: AZD4954, Drug: PlaceboThis additional cohort may be added depending on the findings. |
| Part A1: SAD Cohort 1 (Japanese) - AZD4954 (Dose 2) | Experimental | Drug: AZD4954, Drug: PlaceboJapanese participants will receive a single dose of AZD4954 (Dose 2) or matching placebo on Day 1. |
| Part A1: SAD Cohort 2 (Japanese) - AZD4954 (Dose 3) | Experimental | Drug: AZD4954, Drug: PlaceboJapanese participants will receive a single dose of AZD4954 (Dose 3) or matching placebo on Day 1. |
| Part A1: SAD Optional Cohort 3 (Japanese) - AZD4954 | Experimental | Drug: AZD4954, Drug: PlaceboThis additional cohort may be added depending on the findings. |
| Part A1: SAD Cohort 1 (Chinese) - AZD4954 (Dose 5) | Experimental | Drug: AZD4954, Drug: PlaceboChinese participants will receive a single dose of AZD4954 (Dose 5) or matching placebo at the highest dose level on Day 1. |
| Part A2: SAD Food Effect Cohort - AZD4954 (Dose 2) | Experimental | Drug: AZD4954, Drug: PlaceboParticipants will receive a single dose of AZD4954 (Dose 2) or matching placebo with a high-calorie, high-fat breakfast on Day 1. |
| Part A2: SAD Food Effect Cohort - AZD4954 (Dose 3) | Experimental | Drug: AZD4954, Drug: PlaceboParticipants will receive a single dose of AZD4954 (Dose 3) or matching placebo with a high-calorie, high-fat breakfast on Day 1. |
| Part B: Global MAD Cohort 1 (healthy participants) - AZD4954 (Dose 1) | Experimental | Drug: AZD4954, Drug: PlaceboParticipants will receive multiple doses of AZD4954 (Dose 1) or matching placebo for 21 days. |
| Part B: Global MAD Cohort 2 (healthy participants) - AZD4954 (Dose 2) | Experimental | Drug: AZD4954, Drug: PlaceboParticipants will receive multiple doses of AZD4954 (Dose 2) or matching placebo for 21 days. |
| Part B: Global MAD Cohort 3 (healthy participants) - AZD4954 (Dose 3) | Experimental | Drug: AZD4954, Drug: PlaceboParticipants will receive multiple doses of AZD4954 (Dose 3) or matching placebo for 21 days. |
| Part B: Optional Global MAD Cohort 4 (healthy participants) - AZD4954 | Experimental | Drug: AZD4954, Drug: PlaceboParticipants will receive multiple doses of AZD4954 or matching placebo for 21 days. This additional cohort may be added depending on the findings. |
| Part B: Optional Global MAD Cohort 5 (healthy participants) - AZD4954 | Experimental | Drug: AZD4954, Drug: PlaceboParticipants will receive multiple doses of AZD4954 or matching placebo for 21 days. This additional cohort may be added depending on the findings. |
| Part B: Optional Global MAD Cohort 6 (healthy participants) - AZD4954 | Experimental | Drug: AZD4954, Drug: PlaceboParticipants will receive multiple doses of AZD4954 or matching placebo for 21 days. This additional cohort may be added depending on the findings. |
| Part B: MAD Cohort (Japanese) - AZD4954 (Dose 3) | Experimental | Drug: AZD4954, Drug: PlaceboJapanese participants will receive multiple doses of AZD4954 (Dose 3) or matching placebo for 21 days. |
| Part B: Global MAD Cohort (participants with dyslipidemia) - AZD4954 (Dose 6) | Experimental | Drug: AZD4954, Drug: PlaceboParticipants with dyslipidemia will receive multiple doses of AZD4954 (Dose 6) or matching placebo for 21 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Participants with plasminogen level (concentration) within normal range at the Screening Visit.
- All females must have a negative pregnancy test at the Screening Visit and on admission to the study site.
- 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 at the Screening Visit.
- Sexually active fertile male participants with partners of childbearing potential must adhere to the study specific contraception methods from the time of first administration of study intervention until 3 months after the study Follow-up Visit.
Key exclusion criteria (19 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 study intervention.
- Participants with known bleeding or coagulation disorders.
- Participants who have an elevated high-sensitivity C-reactive protein (> 3 mg/L) or have a prothrombin time/international normalized ratio (PT/INR) or activated partial thromboplastin time (aPTT) > 1.25 times × upper limit normal (ULN).
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 |
|---|---|---|
| AZD4954AZD4954 will be administered orally. | Drug | Part A1: SAD Cohort 1 (Chinese) - AZD4954 (Dose 5), Part A1: SAD Cohort 1 (Japanese) - AZD4954 (Dose 2), Part A1: SAD Cohort 1 - AZD4954 (Dose 1), Part A1: SAD Cohort 2 (Japanese) - AZD4954 (Dose 3), Part A1: SAD Cohort 2 - AZD4954 (Dose 2), Part A1: SAD Cohort 3 - AZD4954 (Dose 3), Part A1: SAD Cohort 4 - AZD4954 (Dose 4), Part A1: SAD Cohort 5 - AZD4954 (Dose 5), Part A1: SAD Optional Cohort 3 (Japanese) - AZD4954, Part A1: SAD Optional Cohort 6 - AZD4954, Part A2: SAD Food Effect Cohort - AZD4954 (Dose 2), Part A2: SAD Food Effect Cohort - AZD4954 (Dose 3), Part B: Global MAD Cohort (participants with dyslipidemia) - AZD4954 (Dose 6), Part B: Global MAD Cohort 1 (healthy participants) - AZD4954 (Dose 1), Part B: Global MAD Cohort 2 (healthy participants) - AZD4954 (Dose 2), Part B: Global MAD Cohort 3 (healthy participants) - AZD4954 (Dose 3), Part B: MAD Cohort (Japanese) - AZD4954 (Dose 3), Part B: Optional Global MAD Cohort 4 (healthy participants) - AZD4954, Part B: Optional Global MAD Cohort 5 (healthy participants) - AZD4954, Part B: Optional Global MAD Cohort 6 (healthy participants) - AZD4954 |
| PlaceboPlacebo will be administered orally. | Drug | Part A1: SAD Cohort 1 (Chinese) - AZD4954 (Dose 5), Part A1: SAD Cohort 1 (Japanese) - AZD4954 (Dose 2), Part A1: SAD Cohort 1 - AZD4954 (Dose 1), Part A1: SAD Cohort 2 (Japanese) - AZD4954 (Dose 3), Part A1: SAD Cohort 2 - AZD4954 (Dose 2), Part A1: SAD Cohort 3 - AZD4954 (Dose 3), Part A1: SAD Cohort 4 - AZD4954 (Dose 4), Part A1: SAD Cohort 5 - AZD4954 (Dose 5), Part A1: SAD Optional Cohort 3 (Japanese) - AZD4954, Part A1: SAD Optional Cohort 6 - AZD4954, Part A2: SAD Food Effect Cohort - AZD4954 (Dose 2), Part A2: SAD Food Effect Cohort - AZD4954 (Dose 3), Part B: Global MAD Cohort (participants with dyslipidemia) - AZD4954 (Dose 6), Part B: Global MAD Cohort 1 (healthy participants) - AZD4954 (Dose 1), Part B: Global MAD Cohort 2 (healthy participants) - AZD4954 (Dose 2), Part B: Global MAD Cohort 3 (healthy participants) - AZD4954 (Dose 3), Part B: MAD Cohort (Japanese) - AZD4954 (Dose 3), Part B: Optional Global MAD Cohort 4 (healthy participants) - AZD4954, Part B: Optional Global MAD Cohort 5 (healthy participants) - AZD4954, Part B: Optional Global MAD Cohort 6 (healthy participants) - AZD4954 |
Primary outcome
Part A: Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Screening (Day -28 to Day -2) to Follow-up visit (Up to Day 29±2 days)
To assess the safety and tolerability of AZD4954 following oral administration of SAD (Part A).
Part B: Number of participants with AEs and SAEs
Time frame: From Screening (Day -28 to Day -2) to Follow-up visit (Up to Day 49±2 days)
To assess the safety and tolerability of AZD4954 following oral administration of MAD (Part B).
21 secondary outcomes
Part A: Area under concentration-time curve from time 0 to infinity (AUCinf)
Time frame: Up to Day 29±2 days
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
Time frame: Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days
Part B: Area under concentration-time curve in the dosing interval (AUCtau)
Time frame: Up to Day 49±2 days
Dose normalized AUClast (AUClast/D)
Time frame: Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days
Dose normalized AUCinf (AUCinf/D)
Time frame: Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days
Part B: Dose normalized AUCtau (AUCtau/D)
Time frame: Up to Day 49±2 days
Apparent total body clearance (CL/F)
Time frame: Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days
Maximum observed drug concentration (Cmax)
Time frame: Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days
Dose normalized Cmax (Cmax/D)
Time frame: Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days
Terminal elimination half-life (t1/2λz)
Time frame: Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days
Time of last quantifiable concentration (tlast)
Time frame: Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days
Time to reach maximum observed concentration (tmax)
Time frame: Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days
Apparent volume of distribution based on the terminal phase (Vz/F)
Time frame: Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days
Individual and cumulative amount of unchanged drug excreted into urine from time t1 to time t2 (Ae[t1-t2])
Time frame: Part A: Up to Day 15; Part B: Up to Day 22
Cumulative amount of unchanged drug excreted into urine (Aeinf)
Time frame: Part A: Up to Day 15; Part B: Up to Day 22
Individual and cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 (fe[t1-t2])
Time frame: Part A: Up to Day 15; Part B: Up to Day 22
Renal clearance (CLR)
Time frame: Part A: Up to Day 15; Part B: Up to Day 22
Part B: Absolute change from baseline in serum Lp(a)
Time frame: Up to Day 49±2 days
Part B: Relative change from baseline in serum Lp(a)
Time frame: Up to Day 49±2 days
Part B: Absolute change from baseline in Lp(a) intact assay
Time frame: Up to Day 49±2 days
Part B: Relative change from baseline in Lp(a) intact assay
Time frame: Up to Day 49±2 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 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.
AstraZeneca Clinical Study Information Center contact
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD4954 in people with Healthy Participants and Dyslipidemia, run by AstraZeneca at 6 sites 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 22 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: From Screening (Day -28 to Day -2) to Follow-up visit (Up to Day 29±2 days)). 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?
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 2 Nov 2026.