A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD1705 in Participants With Dyslipidemia

Running, not enrolling · Phase 1 · Has a placebo group

Conditions studied: Cardiovascular

In brief

A study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD1705 in participants with dyslipidemia.

Key facts

Study ID

NCT06238466

Run by

AstraZeneca

People needed

98

Starts

2024-01-16

Expected to finish

2027-04-08

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male and female of non-childbearing potential participants with suitable veins for cannulation or repeated venipuncture.
• All females must have a negative pregnancy test.
• Participants with elevated lipids.
• BMI between 18 and 35 kg/m\^2.
• Part B1 - May or may not be receiving moderate- or high-intensity statin therapy.
• Part B3
• May or may not be receiving moderate- or high-intensity statin therapy.
• Diagnosed with T2D with hemoglobin A1c (HbA1c) < 8% level.
• Parts B1 and B3
• Participants on medications should be on stable medication for ≥ 3 months before Screening with no planned medication or dose change during study participation.
• Parts A2 and B2:
• Participants are to be Japanese, defined as having both parents and 4 grandparents who are Japanese.
• Part A3:
• Participants are to be Chinese, defined as having both parents and 4 grandparents who are Chinese.

You may not qualify if…

• History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
• 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.
• Any laboratory values with the following deviations at the Screening Visit or on admission to the Clinical Unit. Abnormal values may be repeated once at the discretion of the Investigator:
• Alanine aminotransferase > 1.5 × upper limit of normal (ULN).
• Aspartate aminotransferase > 1.5 × ULN.
• Total bilirubin > ULN (Gilbert's syndrome).
• Estimated glomerular filtration rate < 60 milliliter (mL)/minute/1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation 2021 (National Kidney Foundation).
• Hemoglobin < lower limit normal (LLN).
• Any clinically important abnormalities in hematology, coagulation, clinical chemistry, or urinalysis results other than those described under exclusion criterion number 4, at Screening and/or first admission to the study unit, as judged by the Investigator. Abnormal values may be repeated once at the discretion of the Investigator.
• Any positive result at Screening for serum Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), Hepatitis C virus antibody (HCV Ab), or Human immunodeficiency virus (HIV).
• Abnormal vital signs, after 5 minutes supine rest, at Screening and/or first admission to the study unit, defined as any of the following:
• Systolic blood pressure (BP) ≤ 90 millimeters of mercury (mmHg) or > 140 mmHg (Part A) or > 150 mmHg (Part B).
• Diastolic BP < 50 mmHg or > 90 mmHg.
• Heart rate < 45 or > 90 beats per minute (bpm). Note: Blood pressure will be measured in triplicates and the mean value will be used. Where the values are outside the required range at admission, then based on medical history, one retest may be performed at this visit.
• Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead ECG, at Screening and/or first admission to the study unit, as judged by the Investigator, that may interfere with the interpretation of QT interval corrected for heart rate (QTc) interval changes, including abnormal ST-T-wave morphology, particularly in the protocol-defined primary lead or left ventricular hypertrophy.
• Prolonged ECG interval measured from the onset of the QRS complex to the end of the T wave (QT) corrected for heart rate using Fridericia's correction (QTcF) > 450 ms.
• Family history of long QT syndrome.
• Time from the onset of the P wave to the start of the QRS complex (PR) (PQ) interval shortening < 120 milliseconds (ms) (PR > 110 ms but < 120 ms is acceptable if there is no evidence of ventricular pre-excitation).
• PR (PQ) interval prolongation (> 220 ms), persistent or intermittent second-degree atrioventricular (AV) block (participants with Wenckebach block while asleep are acceptable), third-degree AV block, or AV dissociation.
• Persistent or intermittent complete Bundle branch block (BBB), Intermittent bundle branch block (IBBB), or intraventricular conduction delay (IVCD) with ECG interval measured from the onset of the QRS complex to the J point (QRS) > 110 ms.
• Participants with QRS > 110 ms but < 115 ms (Part A) or < 120 ms (Part B) are acceptable if there is no evidence of ventricular hypertrophy or pre-excitation.
• Smokers who smoke > 10 cigarettes/day and are unable to comply with the nicotine restriction during the study.
• Known or suspected history of alcohol or drug abuse or those who consume > 3 units of alcohol per day for males or > 2 units of alcohol per day for females (where 1 unit being equal to approximately half pint [284 mL] of beer, one small glass [125 mL] of wine, or one measure [25 mL] of spirits) as judged by the Investigator.
• Positive screen for drugs of abuse or alcohol at Screening or on each admission to the Clinical Unit.

Where it is running

• Research Site — Winter Park, Florida, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — San Antonio, Texas, United States
• Research Site — Glendale, California, United States
• Research Site — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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