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AZD7503 Intervention · 1 trial · 6 indications
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...
AZD7503 is being developed for non-alcoholic fatty liver disease, a metabolic liver condition. It is an investigational small molecule from AstraZeneca and has been studied in a Phase 1 trial in adults with NAFLD. It is not an approved treatment.
AZD7503 is developed by AstraZeneca PLC, which trades under the ticker AZN. The company sponsored the Phase 1 clinical trial of the drug in non-alcoholic fatty liver disease conducted in the United States.
AZD7503 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. It is an investigational agent and has not been approved for any indication.
AZD7503 has been evaluated in a single Phase 1 trial, NCT05560607, titled Knockdown of HSD17B13 mRNA, Pharmacokinetics, Safety, and Tolerability, of AZD7503 in Non-Alcoholic Fatty Liver Disease. The completed study enrolled 19 adults in the United States and was uncontrolled.
No. AZD7503 is an investigational small molecule in Phase 1 development for non-alcoholic fatty liver disease and has not received FDA approval. Its only clinical trial, NCT05560607, has been completed.