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

NCT05864391 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: D9230C00002
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 10

Brief Summary

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.

Conditions

Steatohepatitis

Keywords

Cirrhosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Maximum observed plasma drug concentration (Cmax)

  Day 1 to Day 127

• Area under the concentration-time curve from time 0 to infinity (AUCinf) for plasma PK

  Day 1 to 127

• Area under the concentration-time curve over the dosing interval (AUCtau) for plasma PK

  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

  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

Study Arms (3)

Cohort 1

OTHER

Dose A cohort: 20 participants; n=15 on AZD7503 dose A, n=5 on Placebo

Drug: AZD7503

Cohort 2

OTHER

Dose B cohort: 20 participants; n=15 on AZD7503 dose B, n=5 on Placebo.

Drug: AZD7503

Cohort 3

OTHER

Dose C cohort: 20 participants n=15 on AZD7503 dose C, n=5 on Placebo.

Drug: AZD7503

Interventions

AZD7503 DRUG

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.

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Males and females of non-child bearing potential.
• Willing to provide written informed consent and comply with study requirements.

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (10)

Research Site

Chandler, Arizona, 85224, United States

Location

Research Site

Montclair, California, 91763, United States

Location

Research Site

Hialeah, Florida, 33016, United States

Location

Research Site

Port Orange, Florida, 32127, United States

Location

Research Site

Atlanta, Georgia, 30349, United States

Location

Research Site

Morehead City, North Carolina, 28557, United States

Location

Research Site

Houston, Texas, 77079, United States

Location

Research Site

San Antonio, Texas, 78215, United States

Location

Research Site

San Antonio, Texas, 78229, United States

Location

Research Site

San Juan, 00927, Puerto Rico

Location

Related Links

• Redacted CSR synopsis

MeSH Terms

Conditions

Fatty Liver; Fibrosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This is a single-blind, randomised, placebo-controlled, MAD study with up to 3 study intervention cohorts that are participant- and investigator-blinded.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: April 20, 2023
• First Posted: May 18, 2023
• Study Start: March 31, 2023
• Primary Completion: March 20, 2024
• Study Completion: March 20, 2024
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

US (9); PR (1)