Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-24 @ 4:41 PM
NCT ID:
NCT06238466
Brief 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.
Study:
NCT06238466
Study Brief:
Protocol Section:
NCT06238466