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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05560607 | Knockdown of HSD17B13 mRNA, Pharmacokinetics, Safety, and Tolerability, of AZD7503 in Non-Alcoholic Fatty Liver Disease | PHASE1 | COMPLETED | 19 | — | — | Aug 12, 2022 | Feb 27, 2024 | Jul 20, 2025 | 1 | United States |
To assess adverse events as a variable of safety and tolerability of AZD7503.
| Arm | Type | Description |
|---|---|---|
| Intervention/ Drug | EXPERIMENTAL | Investigation of the knockdown of hepatic HSD17B13 mRNA expression, PK, safety, and tolerability following multiple dose administration of AZD7503 in male participants and female participants of non-childbearing potential with NAFLD or NASH |
| Name | Type | Description |
|---|---|---|
| AZD7503 Intervention | DRUG | Part A: Participants will be screened for histologic evidence of NAFLD or NASH and all eligibility criteria in part A prior to enrollment in part B. Part B: Participants consented to part B will be administered the study drug over the course of 31 days. At the end of the study a liver biopsy will be collected to measure for endpoints. |
Inclusion Criteria # Part A 1. Participant must be ≥ 18 to ≤ 70 years of age at the time of signing the informed consent. 2. Participants with suspected or confirmed NAFLD or NASH including laboratory values with any of the following deviations at screening 1. ALT \> ULN, 2. Imaging demonstr...