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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 up to 5 years

Summary

This trial tests a new drug, AZD2693, given through skin injections to people with a liver disease called NASH and a specific genetic risk factor. The goal is to see if the drug is safe and how it works in their bodies.

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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
2023
Completed Phase 1
~230

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
4,411 Previous Clinical Trials
289,122,999 Total Patients Enrolled
ParexelIndustry Sponsor
313 Previous Clinical Trials
96,610 Total Patients Enrolled
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
Fatty Liver Disease Research Study Groups: Cohort 3, Cohort 4, Cohort 1, Cohort 2
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
~15 spots leftby Dec 2025
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