New cholesterol drug enters first human safety tests

NCT ID NCT06980428

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 4 times

Summary

This study is an early-stage trial to check the safety of a new drug called AZD4954. It involves healthy volunteers and people with high cholesterol (dyslipidemia). Researchers will give single and multiple doses to see how the drug moves through the body and if it causes any side effects. The goal is to gather basic safety information, not to treat the condition.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 136 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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. 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): 1. 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. 2. 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 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 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. Exclusion Criteria: 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). * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    RECRUITING

    Glendale, California, 91206, United States

  • Research Site

    RECRUITING

    Inverness, Florida, 34452, United States

  • Research Site

    RECRUITING

    Jacksonville, Florida, 32216, United States

  • Research Site

    RECRUITING

    Port Orange, Florida, 32127, United States

  • Research Site

    RECRUITING

    Brooklyn, Maryland, 21225, United States

  • Research Site

    RECRUITING

    San Antonio, Texas, 78229, United States

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