Investigating the effects of AZD0780 with cholesterol-lowering medications in healthy adults

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.

This study is testing if a new drug called AZD0780 works well and is safe when taken with cholesterol-lowering medications in healthy adults with high cholesterol levels.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: AstraZeneca (industry)
• Locations: 3 sites (Glendale, California and 2 other locations)
• Trial ID: NCT06742853 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the pharmacokinetics, safety, tolerability, and efficacy of AZD0780 when combined with ezetimibe, ezetimibe/rosuvastatin, or ezetimibe/bempedoic acid in healthy adults with elevated LDL-C levels. It is a randomized, single-blind, placebo-controlled trial that will involve a screening period, a run-in period, a treatment period, and follow-up visits. Participants will be assigned to receive either the active drug or a placebo alongside the cholesterol-lowering medications. The study will help determine how well AZD0780 works in this context.

Who should consider this trial

Good fit: Ideal candidates are healthy adults with elevated LDL-C levels between 100 mg/dL and 190 mg/dL.

Not a fit: Patients with a history of clinically important diseases or gastrointestinal, hepatic, or renal disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for managing elevated LDL-C levels in patients.

How similar studies have performed: Other studies have shown promise in using similar combinations of cholesterol-lowering medications, but the specific combination with AZD0780 is novel.

Eligibility criteria

Inclusion Criteria:

1. Signed the informed consent form before any study-related procedure.
2. All females must have a negative serum pregnancy test at the Screening Visit and on admission to the Clinical Unit
3. Females of non-childbearing potential must be confirmed at the Screening Visit by fulfilling one of the following criteria: postmenopausal or surgically sterilized females.
4. Have a Body Mass Index (BMI) \> 18 kg/m² and weigh at least 50 kg.
5. Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
6. 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.
7. Fasting triglycerides \< 400 mg/dL (or \< 10.3 mmol/L for London EPCU) at the Screening Visit.

Exclusion Criteria:

1. History of any clinically important disease or disorder.
2. History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
3. Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
4. 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
5. 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
6. Any positive result on Screening for serum HBsAg, hepatitis B core antibody or human immunodeficiency virus.
7. 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.
8. Treatment with any lipid-lowering therapy or AZD0780 within the 3 months prior to Screening.
9. 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).

Where this trial is running

Glendale, California and 2 other locations

• Research Site — Glendale, California, United States (RECRUITING)
• Research Site — Brooklyn, Maryland, United States (RECRUITING)
• Research Site — Harrow, United Kingdom (RECRUITING)

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions: Dyslipidemia, LDL-C, Hypercholesterolemia, Cholesterol absorption inhibitor, ATP-citrate lyase inhibitor