NCT06742853CompletedPhase 1
A Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of AZD0780 With Ezetimibe Combinations in Healthy Adults With Elevated LDL-C.
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.
Source: ClinicalTrials.gov · Last updated 10 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 81 (actual)
- First submitted
- 16 Dec 2024
- Start date
- 20 Dec 2024
- Primary completion date
- 29 Oct 2025
- Lead sponsor
- AstraZeneca
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT06742853
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 81
- From 20 Dec 2024 to the primary completion date, 29 Oct 2025
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with any lipid-lowering therapy or AZD0780 within the 3 months prior to Screening.
- 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).
Other illness
- 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.
- 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.
Lab values
- 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
- Any positive result on Screening for serum HBsAg, hepatitis B core antibody or human immunodeficiency virus.
Other
- 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
Who the study is looking for
- Signed the informed consent form before any study-related procedure.
- All females must have a negative serum pregnancy test at the Screening Visit and on admission to the Clinical Unit
- Females of non-childbearing potential must be confirmed at the Screening Visit by fulfilling one of the following criteria: postmenopausal or surgically sterilized females.
- Have a Body Mass Index (BMI) \> 18 kg/m² and weigh at least 50 kg.
- Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
- 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.
- Fasting triglycerides \< 400 mg/dL (or \< 10.3 mmol/L for London EPCU) at the Screening Visit.
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Harrow | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Brooklyn | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.