NCT06238466

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

A Phase I Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD1705 Following Single and Multiple Ascending Doses in Participants With Dyslipidemia

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Cardiovascular

Interventions

Type	Name	Description
DRUG	AZD1705	Participants will receive AZD1705 subcutaneously on Day 1 in Part A, and Days 1 and 29 in Part B.
OTHER	Placebo	Participants will receive placebo on Day 1 in Part A, and Days 1 and 29 in Part B.

Timeline

• Start date: 2024-01-16
• Primary completion: 2025-12-01
• Completion: 2026-08-31
• First posted: 2024-02-02
• Last updated: 2026-03-30

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study