AZD7503 for Non-alcoholic Fatty Liver Disease

Recruiting at 1 trial location

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Disqualifiers: Hepatic disease, Liver transplant, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

19 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug called AZD7503 to treat adults with specific liver diseases (NAFLD or NASH) who cannot have children. The drug aims to reduce a harmful substance in the liver. Researchers will check if the drug is safe and how well it works by comparing liver samples over time.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but it mentions that any changes to medications within one month before screening are not allowed. This might mean you should maintain your current medication regimen without changes.

What makes the drug AZD7503 unique for treating non-alcoholic fatty liver disease?

AZD7503 is a novel treatment option for non-alcoholic fatty liver disease (NAFLD), a condition for which there are currently no approved drug therapies. This makes it a potentially groundbreaking option in a field where treatment options are limited. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 70 with suspected or confirmed non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH). They must have certain lab values indicating liver issues, a BMI of at least 20 kg/m2, and histologic evidence of NAFLD/NASH. Women must be of non-childbearing potential.

Inclusion Criteria

Inclusion Criteria # Part A

Participants with suspected or confirmed NAFLD or NASH including laboratory values with any of the following deviations at screening

ALT > ULN

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Part A - Baseline Assessment

Participants undergo a diagnostic liver biopsy to determine NAFLD Activity Score and fibrosis stage

1 week

1 visit (in-person)

Part B - Treatment

Participants receive multiple doses of AZD7503 and undergo repeat liver biopsy at the end-of-treatment

99 days

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• AZD7503

Trial Overview The study tests AZD7503's effects on knocking down HSD17B13 mRNA in patients with NAFLD/NASH. Part A involves diagnosis without intervention; Part B treats confirmed cases with the drug to assess its pharmacokinetics, safety, and tolerability.

How Is the Trial Designed?

Group I: Intervention/ Drug Experimental Treatment 1 Intervention

Investigation of the knockdown of hepatic HSD17B13 mRNA expression, PK, safety, and tolerability following multiple dose administration of AZD7503 in male participants and female participants of non-childbearing potential with NAFLD or NASH

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Published Research Related to This Trial

Non-alcoholic fatty liver disease (NAFLD) is a growing global health issue linked to metabolic disorders, with significant risks for disease progression and mortality, yet there are currently no approved medications for its treatment.

This paper reviews emerging therapeutic strategies and potential drug targets for NAFLD, emphasizing the importance of ongoing clinical trials in developing effective pharmacotherapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for Non-Alcoholic Fatty Liver Disease: Emerging Targets and Drug Candidates. Prikhodko, VA., Bezborodkina, NN., Okovityi, SV.[2023]

In a study of 50 patients with biopsy-proven non-alcoholic fatty liver disease (NAFLD), common clinical features included fatigue (100%), hypertriglyceridemia (80%), and hepatomegaly (72%), indicating a clear pattern of symptoms associated with the disease.

Histopathological analysis revealed that 62% of patients had simple fatty liver, while 38% had nonalcoholic steatohepatitis (NASH), with a significant relationship found between hypertriglyceridemia and the presence of NASH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical and biochemical profile of biopsy-proven non-alcoholic Fatty liver disease subjects. Khurram, M., Ashraf, MM.[2022]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for Non-Alcoholic Fatty Liver Disease: Emerging Targets and Drug Candidates. [2023]

2. England pubmed.ncbi.nlm.nih.gov

From the origin of NASH to the future of metabolic fatty liver disease. [2023]

3. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Evaluation of the effectiveness of differentiated therapy of non-alcoholic fatty liver disease]. [2020]

4. Pakistan pubmed.ncbi.nlm.nih.gov

A clinical and biochemical profile of biopsy-proven non-alcoholic Fatty liver disease subjects. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Cognitive lifetime drinking history in nonalcoholic fatty liver disease: some cases may be alcohol related. [2019]