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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 an investigational small molecule being developed for non-alcoholic fatty liver disease (NAFLD). It is designed to target the liver condition, which is also associated with nonalcoholic steatohepatitis (NASH). The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
AZD7503 is designed to knock down HSD17B13 mRNA, according to its clinical trial title. This mechanism targets the HSD17B13 gene, which is linked to liver fat metabolism and the progression of non-alcoholic fatty liver disease. The drug is being studied for its effects on this molecular target in patients with NAFLD.
AZD7503 is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical research on this investigational drug for the treatment of non-alcoholic fatty liver disease.
AZD7503 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or any other regulatory agency. The drug is still in early-stage clinical trials to evaluate its safety, tolerability, and pharmacokinetics in patients with non-alcoholic fatty liver disease.
AZD7503 has been studied in one clinical trial, identified as NCT05560607. This Phase 1 study, titled 'Knockdown of HSD17B13 mRNA, Pharmacokinetics, Safety, and Tolerability, of AZD7503 in Non-Alcoholic Fatty Liver Disease,' has been completed. The trial enrolled 19 participants in the United States and was not randomized or double-blinded.
AZD7503 is the primary name for this investigational drug, and no alternative names have been reported. It is a distinct small molecule being developed by AstraZeneca for non-alcoholic fatty liver disease. Patients and healthcare providers should refer to it by its official name, AZD7503, in clinical and research contexts.