What side effects are associated with this type of intervention?

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) and Non-alcoholic Steatohepatitis (NASH) include lifestyle modifications, vitamin E, pioglitazone, and newer agents like GLP-1 receptor agonists and SGLT2 inhibitors. Vitamin E can cause gastrointestinal symptoms and, in high doses, may increase the risk of hemorrhagic stroke. Pioglitazone is associated with weight gain, fluid retention, and an increased risk of heart failure and bone fractures. GLP-1 receptor agonists, such as liraglutide, may cause gastrointestinal issues like nausea and vomiting. SGLT2 inhibitors can lead to urinary tract infections and genital infections. These treatments aim to reduce liver fat and inflammation, similar to the goals of AZD2693 in the ongoing study.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved drugs exclusively for the treatment of Non-alcoholic Fatty Liver Disease (NAFLD) or Non-alcoholic Steatohepatitis (NASH). However, some lipid-lowering agents have shown promise in reducing hepatic steatosis in patients with NAFLD/NASH. The study of AZD2693 is focused on its safety, tolerability, pharmacokinetics, and pharmacodynamics in NASH patients with PNPLA3 148M risk alleles, which is a specific genetic risk factor. This indicates ongoing research efforts to find targeted therapies for NASH, but no definitive FDA-approved treatments are currently available.

What other types of research exist?

Promising alternatives to AZD2693 for NAFLD patients include: 1) PF-06427878, which has shown histological improvements in steatosis, ballooning, and fibrosis in NASH mouse models and was well tolerated in phase 1 human studies. 2) Thiazolidinediones like pioglitazone, which have demonstrated efficacy in increasing limb fat and improving insulin resistance in patients with lipoatrophy, suggesting potential benefits for NAFLD. 3) SGLT2 inhibitors, which have shown benefits in glycemic control and weight loss in chronic kidney disease patients and may offer similar benefits in NAFLD, though data in liver disease patients are still emerging.

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AZD2693 for NASH

Phase 1

Waitlist Available

Led By Rohit Loomba, MD, MHSc

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

Study Summary

This trial is testing a new drug for people with NASH, a liver disease, who also have a certain risk allele. The study will see if the drug is safe and effective.

Who is the study for?

This trial is for adults with Non-alcoholic Steatohepatitis (NASH) who are overweight, have specific genetic markers (PNPLA3 148M), and liver fibrosis but not cirrhosis. They must consent to use contraception and can provide a recent liver biopsy or agree to one if needed. People with severe kidney disease, blood disorders that increase bleeding risk, history of major bleeding, or other chronic liver diseases besides NASH cannot join.Check my eligibility

What is being tested?

The study tests AZD2693's safety and effects on the body when given as an injection to people with NASH. It compares different doses of AZD2693 against a placebo in participants with varying stages of liver fibrosis. The drug's behavior in the body (pharmacokinetics) and its impact on the disease process (pharmacodynamics) will be measured.See study design

What are the potential side effects?

While specific side effects for AZD2693 aren't listed here, common ones for similar treatments include reactions at the injection site, gastrointestinal issues like nausea or diarrhea, fatigue, headaches, potential allergic reactions, and changes in liver enzymes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with adverse events

Secondary outcome measures

Absolute change from baseline in Alanine Aminotransferase

Absolute change from baseline in Aspartate Aminotransferase

Absolute change from baseline in Enhanced Liver Fibrosis (ELF) score

+45 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort 4Experimental Treatment2 Interventions

15 participants will receive AZD2693 dose 3 and 5 participants will receive placebo

Group II: Cohort 3Experimental Treatment2 Interventions

15 participants will receive AZD2693 dose 1 and 5 participants will receive placebo

Group III: Cohort 2Experimental Treatment2 Interventions

15 participants will receive AZD2693 dose 2 and 5 participants will receive placebo

Group IV: Cohort 1Experimental Treatment2 Interventions

15 participants will receive AZD2693 dose 1 and 5 participants will receive placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AZD2693

2020

Completed Phase 1

~200

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) include agents like pioglitazone, vitamin E, and newer investigational drugs such as AZD2693. Pioglitazone, a PPAR-gamma agonist, improves insulin sensitivity and reduces liver fat. Vitamin E, an antioxidant, helps reduce oxidative stress and inflammation in the liver. AZD2693, currently under investigation, targets specific pathways involved in lipid metabolism and inflammation, particularly in patients with the PNPLA3 148M risk alleles. These treatments are crucial as they address the underlying metabolic dysfunctions and inflammatory processes that drive NAFLD progression to NASH, thereby potentially preventing liver fibrosis and cirrhosis.

Hepatic steatosis and steatohepatitis: a functional meta-analysis of sex-based differences in transcriptomic studies.

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Who is running the clinical trial?

AstraZenecaLead Sponsor

4,287 Previous Clinical Trials

288,620,076 Total Patients Enrolled

15 Trials studying Non-alcoholic Fatty Liver Disease

3,370 Patients Enrolled for Non-alcoholic Fatty Liver Disease

ParexelIndustry Sponsor

305 Previous Clinical Trials

101,040 Total Patients Enrolled

2 Trials studying Non-alcoholic Fatty Liver Disease

121 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Rohit Loomba, MD, MHScPrincipal InvestigatorDirector, NAFLD Research Center Director of Hepatology, Professor of Medicine Vice Chief, Division of Gastroenterology University of California at San Diego ACTRI Building, 1W202 9500 Gilman Drive La Jolla, CA, 92037-0887

Media Library

AZD2693 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04483947 — Phase 1

Non-alcoholic Fatty Liver Disease Research Study Groups: Cohort 3, Cohort 4, Cohort 1, Cohort 2

Non-alcoholic Fatty Liver Disease Clinical Trial 2023: AZD2693 Highlights & Side Effects. Trial Name: NCT04483947 — Phase 1

AZD2693 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04483947 — Phase 1

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