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

Phase 1

Terminated

• Conditions: Steatohepatitis
• Interventions: Drug: AZD7503

• Registration Number: NCT05864391
• Lead Sponsor: AstraZeneca

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.

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 Timeline

• Study Start: 2023-03-31
• Study First Submitted: 2023-04-20
• Study First Submitted QC: 2023-05-16
• Study First Posted: 2023-05-18
• Primary Completion: 2024-03-20
• Study Completion: 2024-03-20
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 1	AZD7503	Dose A cohort: 20 participants; n=15 on AZD7503 dose A, n=5 on Placebo
Cohort 2	AZD7503	Dose B cohort: 20 participants; n=15 on AZD7503 dose B, n=5 on Placebo.
Cohort 3	AZD7503	Dose C cohort: 20 participants n=15 on AZD7503 dose C, n=5 on Placebo.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Maximum observed plasma drug concentration (Cmax)	Day 1 to Day 127	PK parameters to be collected per the SOA.
Area under the concentration-time curve from time 0 to infinity (AUCinf) for plasma PK	Day 1 to 127	PK parameters to be collected per the SOA.
Area under the concentration-time curve over the dosing interval (AUCtau) for plasma PK	Time frame: Day 1 to 127	PK parameters to be collected per the SOA.
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	PK parameters to be collected per the SOA.

Trial Locations

Locations (1)

Research Site; 🇵🇷 San Juan, Puerto Rico