Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06238466 | A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD1705 in Participants With Dyslipidemia | PHASE1 | ACTIVE NOT_RECRUITING | 98 | — | — | Jan 16, 2024 | Aug 31, 2026 | May 1, 2026 | 5 | United States |
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
| Arm | Type | Description |
|---|---|---|
| Part A1 (AZD1705) | ACTIVE_COMPARATOR | Non-Asian participants will receive AZD1705 subcutaneously on Day 1. |
| Part A2 (AZD1705) | ACTIVE_COMPARATOR | Japanese participants will receive AZD1705 subcutaneously on Day 1. |
| Part A3 (AZD1705) | ACTIVE_COMPARATOR | Chinese participants will receive AZD1705 subcutaneously on Day 1. |
| 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. |
| Part B2 (AZD1705) | ACTIVE_COMPARATOR | Japanese participants not receiving statin therapy will receive AZD1705 subcutaneously on Day 1 and Day 29. |
| 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. |
| Part A1 (Placebo) | PLACEBO_COMPARATOR | Non-Asian participants will receive placebo on Day 1. |
| Part A2 (Placebo) | PLACEBO_COMPARATOR | Japanese participants will receive placebo on Day 1. |
| Part A3 (Placebo) | PLACEBO_COMPARATOR | Chinese participants will receive placebo on Day 1. |
| 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. |
| Part B2 (Placebo) | PLACEBO_COMPARATOR | Japanese participants not receiving statin therapy will receive placebo on Day 1 and Day 29. |
| 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. |
| Name | Type | Description |
|---|---|---|
| AZD1705 | DRUG | Participants will receive AZD1705 subcutaneously on Day 1 in Part A, and Days 1 and 29 in Part B. |
| Placebo | OTHER | Participants will receive placebo on Day 1 in Part A, and Days 1 and 29 in Part B. |
Inclusion Criteria: * 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 receiv...