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

Last updated: April 25, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

1

Condition

Dyslipidemia

Treatment

Placebo

Ezetimibe

Rosuvastatin

Clinical Study ID

NCT06742853
D7960C00017
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The main aim of this study is to assess the effects of AZD0780 when added on top of ezetimibe or ezetimibe and rosuvastatin or ezetimibe and bempedoic acid.

Eligibility Criteria

Inclusion

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 onadmission to the Clinical Unit

  3. Females of non-childbearing potential must be confirmed at the Screening Visit byfulfilling one of the following criteria: postmenopausal or surgically sterilizedfemales.

  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 potentialmust 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 LondonEPCU) at the Screening Visit.

  7. Fasting triglycerides < 400 mg/dL (or < 10.3 mmol/L for London EPCU) at theScreening Visit.

Exclusion

Exclusion Criteria:

  1. History of any clinically important disease or disorder.

  2. History or presence of gastrointestinal, hepatic, or renal disease or any othercondition known to interfere with absorption, distribution, metabolism, or excretionof drugs.

  3. Any clinically important illness, medical/surgical procedure, or trauma within 4weeks 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 filtrationrate, or hemoglobin at the Screening Visit or on Admission

  5. Any clinically important abnormalities in clinical chemistry, hematology, orurinalysis results other than those described under exclusion criterion number 4, atScreening and/or Admission to the Clinical Unit

  6. Any positive result on Screening for serum HBsAg, hepatitis B core antibody or humanimmunodeficiency virus.

  7. History of severe allergy/hypersensitivity or ongoing clinically importantallergy/hypersensitivity, as judged by the investigator or history ofhypersensitivity 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 toScreening.

  9. Treatment with drugs for reduction or inhibition of Proprotein convertasesubtilisin/kexin type 9 (PCSK9) within the last 12 months prior to Screening (approved or investigational and apart from AZD0780).

Study Design

Total Participants: 120
Treatment Group(s): 5
Primary Treatment: Placebo
Phase: 1
Study Start date:
December 20, 2024
Estimated Completion Date:
December 04, 2025

Study Description

This is a randomized, single-blind, placebo-controlled study in healthy participants with elevated low-density lipoprotein-cholesterol (LDL-C).

This study will assess the pharmacokinetic (PK), safety, tolerability, and efficacy of AZD0780 in combination with ezetimibe, ezetimibe/rosuvastatin, and ezetimibe/bempedoic acid.

Participants will be randomized to receive either AZD0780 or placebo (to be administered with ezetimibe, ezetimibe/rosuvastatin, or ezetimibe/bempedoic acid).

The study will comprise:

  1. A Screening Period of up to 28 days.

  2. A Run-in Period of 28 days.

  3. A Treatment Period of 28 days.

  4. Two Follow-up Visits, one and two weeks after the last dose of study drug.

Connect with a study center

  • Research Site

    Harrow, HA1 3UJ
    United Kingdom

    Active - Recruiting

  • Research Site

    Glendale, California 91206
    United States

    Active - Recruiting

  • Research Site

    Brooklyn, Maryland 21225
    United States

    Active - Recruiting

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