A Study to Investigate Safety, Tolerability, and Pharmacokinetics of AZD7503 in Participants With Suspected NASH.

A Phase I Randomized Single-blind Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD7503 Following Multiple Ascending Dose Administration to Patients With Suspected Non-cirrhotic Non-alcoholic Steatohepatitis (NASH)

The purpose of this study is to measure the safety, tolerability, and PK (measurement of drug activity in the body over time) of AZD7503 injected subcutaneously, and compared to placebo, in participants with suspected NASH, a type of liver disease.

Study Overview

• Status: Terminated
• Conditions: Steatohepatitis
• Intervention / Treatment: Drug: AZD7503

Detailed Description

This is a Phase I, randomised, single-blind (in which the study centre staff including the Principal Investigator, remain blinded during the clinical conduct of a given cohort) placebo controlled, multiple ascending dose (MAD) study in male and female participants conducted at multiple centres.

Each participant is expected to be in the study for approximately 24 weeks, including a screening period of up to 4 weeks, a 12-week study intervention period, and a follow-up visit at week 18 (10 weeks following the final dose). Participants will be randomly assigned in a 3:1 ratio to receive AZD7503 or placebo. Study intervention will be administered via subcutaneous injection.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00927
    • Research Site
• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Research Site
  • California
    • Montclair, California, United States, 91763
      • Research Site
  • Florida
    • Hialeah, Florida, United States, 33016
      • Research Site
    • Port Orange, Florida, United States, 32127
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30349
      • Research Site
  • North Carolina
    • Morehead City, North Carolina, United States, 28557
      • Research Site
  • Texas
    • Houston, Texas, United States, 77079
      • Research Site
    • San Antonio, Texas, United States, 78229
      • Research Site
    • San Antonio, Texas, United States, 78215
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria

1. Biopsy-confirmed NASH diagnosis with CRN score of fibrosis stage of F1 to F3 within the previous 12 months prior to screening or history of fatty liver disease by imaging plus clinical suspicion of NASH based on history of type 2 DM for at least 5 years or overweight/obesity with BMI 25 to 40 kg/m^2 with 2 additional metabolic syndrome components.
2. Males and females of non-child bearing potential.
3. Willing to provide written informed consent and comply with study requirements.

Key Exclusion Criteria

1. Evidence of any clinical important condition which in the investigator opinion makes it undesirable for the participant to participate in the study
2. Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention
3. History of liver transplant or presence or history of hepatic disease other than NASH or histological or imaging evidence of cirrhosis.
4. Human immunodeficiency virus (HIV) infection, seropositive for Hepatitis B (HBV)virus, seropositive for Hepatitis C virus (HCV)
5. History of excessive alcohol consumption
6. Uncontrolled high blood pressure
7. Any clinically important abnormalities in ECG
8. Suspected history of illicit drug abuse
9. Clinically important abnormalities in urine and blood laboratory results
10. Changes in concomitant medication within 1 month of screening
11. Received another investigational drug within 90 days of administration of study intervention in this study
12. Has received any chemical entity or investigational drug targeting HSD17B13 (eg, ARO-HSD or ALN-HSD).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cohort 1; Dose A cohort: 20 participants; n=15 on AZD7503 dose A, n=5 on Placebo	Drug: AZD7503; Each participant is expected to be in the study for approximately 24 weeks, including a screening period of up to 28 days, a 12-week study intervention period, and a follow-up visit at week 18 (10 weeks following the final dose). Participants will be randomly assigned in a 3:1 ratio to receive AZD7503 or placebo. Study intervention will be administered via subcutaneous injection.
Other: Cohort 2; Dose B cohort: 20 participants; n=15 on AZD7503 dose B, n=5 on Placebo.	Drug: AZD7503; Each participant is expected to be in the study for approximately 24 weeks, including a screening period of up to 28 days, a 12-week study intervention period, and a follow-up visit at week 18 (10 weeks following the final dose). Participants will be randomly assigned in a 3:1 ratio to receive AZD7503 or placebo. Study intervention will be administered via subcutaneous injection.
Other: Cohort 3; Dose C cohort: 20 participants n=15 on AZD7503 dose C, n=5 on Placebo.	Drug: AZD7503; Each participant is expected to be in the study for approximately 24 weeks, including a screening period of up to 28 days, a 12-week study intervention period, and a follow-up visit at week 18 (10 weeks following the final dose). Participants will be randomly assigned in a 3:1 ratio to receive AZD7503 or placebo. Study intervention will be administered via subcutaneous injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with adverse events (AEs)	AEs will be collected at all sites visits per SOA.	Up to and including week 19 (from pre-screening to follow-up visit)
Number of subjects with serious adverse events (SAEs)	SAEs will be reported and collected as they occur.	Up to and including week 18 (from pre-screening to final visit).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum observed plasma drug concentration (Cmax)	PK parameters to be collected per the SOA.	Day 1 to Day 127
Area under the concentration-time curve from time 0 to infinity (AUCinf) for plasma PK	PK parameters to be collected per the SOA.	Day 1 to 127
Area under the concentration-time curve over the dosing interval (AUCtau) for plasma PK	PK parameters to be collected per the SOA.	Time frame: Day 1 to 127
Fraction of the dose excreted unchanged into the urine from time t1 to t2 (fe(t1-t2)) for urine PK	PK parameters to be collected per the SOA.	Day 1 and Day 57: Pre-dose and between 0-6 hours, 6-12 hours, 12-24 hours, 24-36 hours and 36-48 hours post-dose

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Eric Lawitz, MD, American Research Corporation; Principal Investigator: William Sanchez, MD, Floridian Clinical Research; Principal Investigator: Linda Martinez, MD, Oracle Clinical Research; Principal Investigator: Niharika Samala, MD, Indiana University; Principal Investigator: Kathryn Lucas, MD, Lucas Research, Inc.; Principal Investigator: Anita Kohli, MD, The Institute for Liver Health DBA Arizona Liver Health; Principal Investigator: Mazen Noureddin, MD, Houston Research Institute; Principal Investigator: Madhavi Rudraraju, MD, Pinnacle Clinical Research; Principal Investigator: Richard Mohammed, MD, Progressive Medical Research; Principal Investigator: Grisell Ortiz-Lasanta, MD, FDI Clinical Research; Principal Investigator: Rizwana Mohseni, MD, Catalina Research Institute, LLC

Publications and helpful links

Helpful Links

• Redacted CSR synopsis

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2023
• Primary Completion (Actual): March 20, 2024
• Study Completion (Actual): March 20, 2024

Study Registration Dates

• First Submitted: April 20, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Actual): July 20, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Cirrhosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver
• Other Study ID Numbers: D9230C00002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No