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

Last updated: September 8, 2025
Sponsor: AstraZeneca
Overall Status: Active - Not Recruiting

Phase

1

Condition

N/A

Treatment

AZD1705

Placebo

Clinical Study ID

NCT06238466
D7650C00001
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female of non-childbearing potential participants with suitable veins forcannulation 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.

Exclusion

Exclusion Criteria:

  • History of any clinically important disease or disorder which, in the opinion of theInvestigator, may either put the participant at risk because of participation in thestudy, or influence the results or the participant's ability to participate in thestudy.

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

  • Any clinically important illness, medical/surgical procedure, or trauma within 4weeks of the first administration of study intervention.

  • Any laboratory values with the following deviations at the Screening Visit or onadmission to the Clinical Unit. Abnormal values may be repeated once at thediscretion of the Investigator:

  1. Alanine aminotransferase > 1.5 × upper limit of normal (ULN).

  2. Aspartate aminotransferase > 1.5 × ULN.

  3. Total bilirubin > ULN (Gilbert's syndrome).

  4. Estimated glomerular filtration rate < 60 milliliter (mL)/minute/1.73 m2calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation 2021 (National Kidney Foundation).

  5. Hemoglobin < lower limit normal (LLN).

  • Any clinically important abnormalities in hematology, coagulation, clinicalchemistry, or urinalysis results other than those described under exclusioncriterion number 4, at Screening and/or first admission to the study unit, as judgedby the Investigator. Abnormal values may be repeated once at the discretion of theInvestigator.

  • Any positive result at Screening for serum Hepatitis B surface antigen (HBsAg),Hepatitis B core antibody (HBcAb), Hepatitis C virus antibody (HCV Ab), or Humanimmunodeficiency virus (HIV).

  • Abnormal vital signs, after 5 minutes supine rest, at Screening and/or firstadmission to the study unit, defined as any of the following:

  1. Systolic blood pressure (BP) ≤ 90 millimeters of mercury (mmHg) or > 140 mmHg (Part A) or > 150 mmHg (Part B).

  2. Diastolic BP < 50 mmHg or > 90 mmHg.

  3. Heart rate < 45 or > 90 beats per minute (bpm). Note: Blood pressure will bemeasured in triplicates and the mean value will be used. Where the values areoutside the required range at admission, then based on medical history, oneretest may be performed at this visit.

  • Any clinically important abnormalities in rhythm, conduction, or morphology of theresting 12-lead ECG, at Screening and/or first admission to the study unit, asjudged by the Investigator, that may interfere with the interpretation of QTinterval corrected for heart rate (QTc) interval changes, including abnormalST-T-wave morphology, particularly in the protocol-defined primary lead or leftventricular hypertrophy.
  1. Prolonged ECG interval measured from the onset of the QRS complex to the end ofthe T wave (QT) corrected for heart rate using Fridericia's correction (QTcF) > 450 ms.

  2. Family history of long QT syndrome.

  3. 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 isacceptable if there is no evidence of ventricular pre-excitation).

  4. PR (PQ) interval prolongation (> 220 ms), persistent or intermittentsecond-degree atrioventricular (AV) block (participants with Wenckebach blockwhile asleep are acceptable), third-degree AV block, or AV dissociation.

  5. Persistent or intermittent complete Bundle branch block (BBB), Intermittentbundle branch block (IBBB), or intraventricular conduction delay (IVCD) withECG 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) areacceptable if there is no evidence of ventricular hypertrophy or pre-excitation.

  • Smokers who smoke > 10 cigarettes/day and are unable to comply with the nicotinerestriction during the study.

  • Known or suspected history of alcohol or drug abuse or those who consume > 3 unitsof alcohol per day for males or > 2 units of alcohol per day for females (where 1unit being equal to approximately half pint [284 mL] of beer, one small glass [125mL] 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 tothe Clinical Unit.

  • 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 studycompound.

  • Excessive intake of caffeine-containing drinks or food (eg, coffee, tea, chocolate)defined as the regular consumption of more than 500 mg of caffeine per day (one cup ~100 mg caffeine; one cup of tea ~30 mg caffeine) or would likely be unable torefrain from the use of caffeine-containing beverages during confinement at theinvestigational site.

  • Plasma donation within one month of the Screening Visit or any blood donation/bloodloss > 500 mL during the 3 months prior to the Screening Visit.

  • Has received another new chemical entity (defined as a compound which has not beenapproved for marketing) within 30 days or 5 half-lives (whichever is longest) of thefirst administration of investigational medicinal product (IMP). The period ofexclusion begins after the final dose.

  • Involvement in the planning and/or conduct of the study (applies to both AstraZenecastaff and/or staff at the Clinical Unit).

  • Judgment by the Investigator that the participant should not participate in thestudy if they have any ongoing or recent (ie, during the Screening Period) minormedical complaints that may interfere with the interpretation of study data or areconsidered unlikely to comply with study procedures, restrictions, and requirements.

  • Participants who are vegans or have medical dietary restrictions.

  • Participants who cannot communicate reliably with the Investigator.

  • Vulnerable participants, eg, kept in detention, protected adults under guardianship,trusteeship, or committed to an institution by governmental or juridical order.

  • Clinical signs and symptoms consistent with COVID-19, eg, fever, dry cough, dyspnea,sore throat, fatigue, or confirmed infection by appropriate laboratory test withinthe last 4 weeks prior to Screening or on admission as per site standard practice.

  • Low-density lipoprotein (LDL) or plasma apheresis within 12 months prior torandomization.

Part A Only:

  • Use of any prescribed or nonprescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, mega dose vitamins (intakeof 20 to 600 times the recommended daily dose), and minerals during the 2 weeksprior to the first administration of study intervention or longer if the medicationhas a long half-life.

  • On statin therapy.

  • Urine albumin: creatinine ratio > 30 mg/g.

Part B Only:

  • Use of any herbal remedies, mega dose vitamins, and minerals during the two weeksprior to the first administration of study intervention or 5 half-lives, whicheveris longer.

  • Urine albumin: creatinine ratio > 100 mg/g.

Parts B1 and B3 Only:

  • Contraindication to Magnetic Resonance Imaging (MRI) such as: participants with pacemakers, metallic cardiac valves, magnetic material such as surgical clips, implanted electronic infusion pumps or other conditions that would preclude proximity to a strong magnetic field; participants with a history of extreme claustrophobia; or participants who cannot fit inside the MRI scanner cavity.

Study Design

Total Participants: 96
Treatment Group(s): 2
Primary Treatment: AZD1705
Phase: 1
Study Start date:
January 16, 2024
Estimated Completion Date:
December 02, 2025

Study Description

This is a first time in human study in male and female (of non-childbearing potential) participants with dyslipidemia. The study consists of two parts:

  1. Part A (single ascending dose): Part A of the study will include three parts: A1 for non-Asian participants, A2 for Japanese participants, and A3 for Chinese participants. Parts A2 and A3 are optional.

  2. Part B (multiple ascending dose): Part B of the study will include three parts: B1 for non-Asian participants who may or may not be receiving moderate- or high-intensity statin therapy, B2 for Japanese participants not receiving statin therapy, and B3 for participants who may or may not be receiving moderate- or high-intensity statin therapy, with the additional diagnosis of type 2 diabetes (T2D), and with HbA1c < 8%. Parts B2 and B3 are optional.

The study will comprise of:

  • A Screening Period of maximum 60 days for both Part A and Part B.

  • Part A: A single dose of AZD1705 with an in-clinic period of 3 days.

  • An outpatient Follow-up Period of approximately 16 weeks.

  • Part B: 2 doses of AZD1705, given 28 days apart with an in-clinic period.

  • An outpatient Follow-up Period of approximately 20 weeks.

Connect with a study center

  • Research Site

    Glendale, California 91206
    United States

    Site Not Available

  • Research Site

    Glendale 5352423, California 5332921 91206
    United States

    Site Not Available

  • Research Site

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Research Site

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Research Site

    Jacksonville 4160021, Florida 4155751 32216
    United States

    Site Not Available

  • Research Site

    Winter Park 4178560, Florida 4155751 32789
    United States

    Site Not Available

  • Research Site

    Overland Park, Kansas 66212
    United States

    Site Not Available

  • Research Site

    Baltimore, Maryland 21225
    United States

    Site Not Available

  • Research Site

    Brooklyn, Maryland 21225
    United States

    Site Not Available

  • Research Site

    Baltimore 4347778, Maryland 4361885 21225
    United States

    Site Not Available

  • Research Site

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Research Site

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

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