New cholesterol drug enters first human safety tests
NCT ID NCT06980428
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 136 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Research Site
RECRUITINGGlendale, California, 91206, United States
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Research Site
RECRUITINGInverness, Florida, 34452, United States
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Research Site
RECRUITINGJacksonville, Florida, 32216, United States
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Research Site
RECRUITINGPort Orange, Florida, 32127, United States
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Research Site
RECRUITINGBrooklyn, Maryland, 21225, United States
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Research Site
RECRUITINGSan Antonio, Texas, 78229, United States
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