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

NCT06238466 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: D7650C00001
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Cardiovascular

Keywords

Dyslipidemia; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events (AEs) and serious adverse events (SAEs)

  To assess the safety and tolerability of AZD1705 following subcutaneous administration of single ascending doses (Part A) and multiple ascending doses (Part B) in participants with dyslipidemia

  Part A: From Screening (Day -60 to Day -2) until Day 113. Part B: From Screening until Day 141

Secondary Outcomes (10)

• Area under plasma concentration-time curve from zero extrapolated to infinity (AUCinf)

  Part A: Day 1 to 113. Part B: Day 1 to 141

• Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast)

  Part A: Day 1 to 113. Part B: Day 1 to 141

• Maximum observed plasma (peak) drug concentration (Cmax)

  Part A: Day 1 to 113. Part B: Day 1 to 141

• Cumulative amount of drug excreted unchanged (Ae)

  Part A: Day 1 to 4. Part B: Day 1 to 4, and 29 to 30

• Fraction of drug excreted unchanged (fe)

  Part A: Day 1 to 4. Part B: Day 1 to 4, and 29 to 30

Study Arms (12)

Part A1 (AZD1705)

ACTIVE COMPARATOR

Non-Asian participants will receive AZD1705 subcutaneously on Day 1.

Drug: AZD1705

Part A2 (AZD1705)

ACTIVE COMPARATOR

Japanese participants will receive AZD1705 subcutaneously on Day 1.

Drug: AZD1705

Part A3 (AZD1705)

ACTIVE COMPARATOR

Chinese participants will receive AZD1705 subcutaneously on Day 1.

Drug: AZD1705

Part B1 (AZD1705)

ACTIVE COMPARATOR

Non-Asian participants who may or may not be receiving moderate- or high-intensity statin therapy will receive AZD1705 subcutaneously on Day 1 and Day 29.

Drug: AZD1705

Part B2 (AZD1705)

ACTIVE COMPARATOR

Japanese participants not receiving statin therapy will receive AZD1705 subcutaneously on Day 1 and Day 29.

Drug: AZD1705

Part B3 (AZD1705)

ACTIVE COMPARATOR

Participants who may or may not be receiving moderate- or high-intensity statin therapy and with the additional diagnosis of type 2 diabetes will receive AZD1705 subcutaneously on Day 1 and Day 29.

Drug: AZD1705

Part A1 (Placebo)

PLACEBO COMPARATOR

Non-Asian participants will receive placebo on Day 1.

Other: Placebo

Part A2 (Placebo)

PLACEBO COMPARATOR

Japanese participants will receive placebo on Day 1.

Other: Placebo

Part A3 (Placebo)

PLACEBO COMPARATOR

Chinese participants will receive placebo on Day 1.

Other: Placebo

Part B1 (Placebo)

PLACEBO COMPARATOR

Non-Asian participants who may or may not be receiving moderate- or high-intensity statin therapy will receive placebo on Day 1 and Day 29.

Other: Placebo

Part B2 (Placebo)

PLACEBO COMPARATOR

Japanese participants not receiving statin therapy will receive placebo on Day 1 and Day 29.

Other: Placebo

Part B3 (Placebo)

PLACEBO COMPARATOR

Participants who may or may not be receiving moderate- or high-intensity statin therapy and with the additional diagnosis of type 2 diabetes will receive placebo on Day 1 and Day 29.

Other: Placebo

Interventions

AZD1705 DRUG

Participants will receive AZD1705 subcutaneously on Day 1 in Part A, and Days 1 and 29 in Part B.

Part A1 (AZD1705); Part A2 (AZD1705); Part A3 (AZD1705); Part B1 (AZD1705); Part B2 (AZD1705); Part B3 (AZD1705)

Placebo OTHER

Participants will receive placebo on Day 1 in Part A, and Days 1 and 29 in Part B.

Part A1 (Placebo); Part A2 (Placebo); Part A3 (Placebo); Part B1 (Placebo); Part B2 (Placebo); Part B3 (Placebo)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (5)

Research Site

Glendale, California, 91206, United States

Location

Research Site

Jacksonville, Florida, 32216, United States

Location

Research Site

Winter Park, Florida, 32789, United States

Location

Research Site

Baltimore, Maryland, 21225, United States

Location

Research Site

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Single Blind
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 2, 2024
• Study Start: January 16, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

US (5)