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Knockdown of HSD17B13 mRNA, Pharmacokinetics, Safety, and Tolerability, of AZD7503 in Non-Alcoholic Fatty Liver Disease

CompletedPhase 1

Sponsor: AstraZeneca

Conditions: Non-alcoholic Fatty Liver Disease, Fatty Liver, Nonalcoholic, NAFLD, Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis

Interventions: AZD7503 Intervention

Countries: United States

This is a two-part study. In Part A, eligible participants will undergo a baseline diagnostic liver biopsy to determine non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) and fibrosis stage, but will not receive study intervention. In Part B, participants with histologically confirmed NAFLD or non-alcoholic steatohepatitis (NASH) will receive study intervention.

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 demonstrating hepatic steatosis including controlled attenuation parameter (CAP) \>290 dB/m, OR Liver stiffness of \>7.1 kPa as measured by Fibroscan.
3. Body mass index (BMI) ≥20 kg/m2.
4. Male and /or female of non-child bearing potential.

   Inclusion Criteria # Part B
5. Histologic evidence of NAFLD or NASH with a NAS ≥3 following baseline liver biopsy.

Exclusion Criteria:

1. History or presence of hepatic disease (with the exception of hepatic steatosis, NASH) or evidence of other known forms of known chronic liver
2. History of liver transplant, evidence of cirrhosis, or current placement on a liver transplant
3. Positive results for HIV antigen and hepatitis B surface antigen If a participant has a positive result at the screening visit for hepatitis C antibody, the investigator will document that the participant has hepatitis C RNA below the limit of detection and has not received curative treatment in the last 3 years.
4. History of alcohol abuse or excessive intake of alcohol as judged by the investigator.
5. Uncontrolled blood pressure, defined as any of the following during pre-screening and/or Day -1 (mean of 3 measurements):

   1. Systolic blood pressure \>160 mmHg.
   2. Diastolic blood pressure \>100 mmHg.
6. Any clinically important abnormalities in rhythm, conduction or morphology of the resting ECG.
7. Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results,
8. Known or suspected history of drug abuse as judged by the investigator.
9. Positive screen for drugs of abuse at screening or admission to the study site prior to the administration of the study intervention.
10. Changes to any concomitant medication (initiation, dose change, or cessation) within one month prior to the screening visit.
11. Any laboratory values with following deviations at screening (one re-test allowed):

    1. (a) ALT \>3X ULN
    2. (b) AST \>3X ULN
    3. (c) TBL \>ULN or INR ≥1.3
    4. (d) ALP \>1.5X ULN
    5. (e) eGFR \<60 mL/min/1.73 m2 (calculated using CKD Epidemiology Collaboration
    6. \[CKD-EPI\] formula) and applying the standard correction factor for African
    7. American to the (CKD-EPI) by multiplying the GFR estimate by 1.159 and
    8. confirmed.
    9. (f) Platelets \<150 × 109/L

Locations (1)

San Antonio, Texas, United States