SteatohepatitisPhase 1NCT05864391
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of AZD7503 in Participants With Suspected NASH.
A Phase 1 study testing AZD7503 in people with Steatohepatitis, run by AstraZeneca at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Steatohepatitis
- What is being tested?
- AZD7503
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 31 Mar 2023to 20 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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).
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Research Site
Atlanta, Georgia, 30349
Research Site
Chandler, Arizona, 85224
Research Site
Hialeah, Florida, 33016
Research Site
Houston, Texas, 77079
Research Site
Montclair, California, 91763
Research Site
Morehead City, North Carolina, 28557
Research Site
Port Orange, Florida, 32127
Research Site
San Antonio, Texas, 78215
Research Site
San Antonio, Texas, 78229
About this study
Official title: 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.
Read the 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.
- Conditions
- Steatohepatitis
- Being tested
- AZD7503
- Keywords
- Cirrhosis
- Medical subject headings
- Fatty Liver, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD7503Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Other | Dose A cohort: 20 participants; n=15 on AZD7503 dose A, n=5 on Placebo Receives: Drug: AZD7503 |
| Cohort 2 | Other | Dose B cohort: 20 participants; n=15 on AZD7503 dose B, n=5 on Placebo. Receives: Drug: AZD7503 |
| Cohort 3 | Other | Dose C cohort: 20 participants n=15 on AZD7503 dose C, n=5 on Placebo. Receives: Drug: AZD7503 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events (AEs)
AEs will be collected at all sites visits per SOA.
Measured: 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.
Measured: Up to and including week 18 (from pre-screening to final visit).
Secondary outcomes (4)
Maximum observed plasma drug concentration (Cmax)
PK parameters to be collected per the SOA.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start31 Mar 2023
- Primary completion20 Mar 2024
- Study completion20 Mar 2024
Why it stopped: AstraZeneca have decided to not move forward with the development of the compound.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SteatohepatitisStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864391
- Sponsor's protocol ID
- D9230C00002
- Status last verified
- Jul 2025
- First submitted
- 20 Apr 2023
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05864391
- Acronym / sponsor ID
- D9230C00002
- Conditions
- Steatohepatitis
- Keywords
- Cirrhosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: AstraZeneca have decided to not move forward with the development of the compound.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Other | Drug: AZD7503Dose A cohort: 20 participants; n=15 on AZD7503 dose A, n=5 on Placebo |
| Cohort 2 | Other | Drug: AZD7503Dose B cohort: 20 participants; n=15 on AZD7503 dose B, n=5 on Placebo. |
| Cohort 3 | Other | Drug: AZD7503Dose C cohort: 20 participants n=15 on AZD7503 dose C, n=5 on Placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD7503Each 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. | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Number of subjects with adverse events (AEs)
Time frame: 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)
Time frame: Up to and including week 18 (from pre-screening to final visit).
SAEs will be reported and collected as they occur.
4 secondary outcomes
Maximum observed plasma drug concentration (Cmax)
Time frame: Day 1 to Day 127
Area under the concentration-time curve from time 0 to infinity (AUCinf) for plasma PK
Time frame: Day 1 to 127
Area under the concentration-time curve over the dosing interval (AUCtau) for plasma PK
Time frame: 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
Time frame: 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
Results and safety
The study was stopped early (reason given: AstraZeneca have decided to not move forward with the development of the compound.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Redacted CSR synopsisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD7503 in people with Steatohepatitis, run by AstraZeneca at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: AstraZeneca have decided to not move forward with the development of the compound.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with adverse events (AEs) (time frame: Up to and including week 19 (from pre-screening to follow-up visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.