A Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of AZD0780 With Ezetimibe Combinations in Healthy Adults With Elevated LDL-C.

Launched by ASTRAZENECA · Dec 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called AZD0780 and how it works when combined with other cholesterol-lowering treatments, like ezetimibe, rosuvastatin, or bempedoic acid. The main goal is to understand how well AZD0780 can help lower bad cholesterol (LDL-C) levels in healthy adults who have slightly elevated cholesterol levels.

To participate, individuals must be between the ages of 18 and 75, have a Body Mass Index (BMI) greater than 18, and have certain cholesterol levels. Women must have a negative pregnancy test, and men must use contraception if their partner could become pregnant. Participants will be given the study medication and monitored for safety and effectiveness. This study is currently recruiting volunteers, and anyone interested should discuss it with their doctor to see if they qualify.

Gender

ALL

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).