#1 Clinical Trials Search in Europe

Azd2693 Sodium

A groundbreaking clinical trial is underway to assess the effectiveness, safety, and tolerability of AZD2693 Sodium, a promising new drug for treating non-cirrhotic non-alcoholic steatohepatitis (NASH) with fibrosis. This study focuses on adult participants who carry a specific genetic marker, offering hope for a targeted treatment approach in NASH management.

Table of Contents

What is AZD2693 SODIUM?

AZD2693 SODIUM is an investigational drug being developed by AstraZeneca for the treatment of non-alcoholic steatohepatitis (NASH) with fibrosis. It is a synthetic small molecule that is administered as a solution for injection[1]. The drug is specifically designed to target individuals who carry a specific genetic marker called PNPLA3 rs738409 148M risk allele[1].

Target Condition: Non-Alcoholic Steatohepatitis (NASH)

Non-alcoholic steatohepatitis (NASH) is a severe form of non-alcoholic fatty liver disease. It is characterized by fat accumulation in the liver, inflammation, and liver cell damage. NASH can lead to fibrosis (scarring) of the liver and potentially progress to cirrhosis if left untreated[1]. The condition targeted by AZD2693 SODIUM is specifically non-cirrhotic NASH with fibrosis, meaning the liver damage has not yet progressed to cirrhosis.

Clinical Trial Overview

A Phase 2b clinical trial is being conducted to evaluate the efficacy, safety, and tolerability of AZD2693 SODIUM in adults with non-cirrhotic NASH and fibrosis who carry the PNPLA3 genetic marker[1]. The study is:

  • Randomized: Participants are randomly assigned to either the treatment or placebo group
  • Double-blind: Neither the participants nor the researchers know who is receiving the actual drug or placebo
  • Placebo-controlled: Some participants receive a placebo for comparison
  • Multi-center: Conducted at multiple medical centers

Eligibility Criteria

To participate in this study, individuals must meet specific criteria, including[1]:

Inclusion Criteria:

  • Age: 18 to 75 years old
  • Carry the PNPLA3 rs738409 148M risk allele (a specific genetic marker)
  • Have histological evidence of NASH based on a liver biopsy, with a NAS (NAFLD Activity Score) ≥ 4
  • Have liver fibrosis stage F2 or F3 (moderate to advanced fibrosis)

Exclusion Criteria:

  • Other liver diseases (e.g., alcoholic steatohepatitis, viral hepatitis)
  • History of cirrhosis or liver decompensation
  • Severe kidney disease
  • Certain abnormal liver function tests

Study Objectives

The main goal of this study is to assess how well AZD2693 SODIUM works compared to a placebo in treating NASH. Specifically, the researchers aim to[1]:

  1. Evaluate the effect on histological resolution of NASH (improvement in liver tissue appearance) after 52 weeks of treatment
  2. Assess improvements in liver fibrosis
  3. Measure improvements in the NAS score

Study Endpoints

The study will measure several outcomes to determine the effectiveness of AZD2693 SODIUM[1]:

Primary Endpoint:

Resolution of NASH without worsening of liver fibrosis after 52 weeks. This means:

  • A ballooning score of 0 (no liver cell ballooning)
  • An inflammation score of 0 to 1 (little to no inflammation)
  • Any degree of steatosis (fat in the liver)

Secondary Endpoints:

  • Improvement in liver fibrosis by at least one stage without worsening of NASH
  • At least a 2-point improvement in the NAS score

Drug Administration

AZD2693 SODIUM is administered as a solution for injection via subcutaneous use (an injection under the skin)[1]. The treatment period in this study is 52 weeks, which is about one year. The exact dosage is not specified in the provided information.

It’s important to note that this drug is still in the investigational stage, and more research is needed to fully understand its effectiveness and safety profile for treating NASH.

Aspect Details
Drug Name AZD2693 Sodium
Condition Studied Non-cirrhotic non-alcoholic steatohepatitis (NASH) with fibrosis
Study Type Randomized, double-blind, placebo-controlled, multi-centre Phase 2b
Primary Objective Assess effect on histological resolution of NASH without worsening fibrosis
Key Inclusion Criteria Adults 18-75, PNPLA3 rs738409 148M risk allele carriers, histological evidence of NASH
Treatment Duration 52 weeks
Administration Route Subcutaneous injection
Primary Endpoint Resolution of NASH without worsening of liver fibrosis after 52 weeks

FAQ

  • What is the main purpose of this clinical trial? The main purpose is to evaluate how well AZD2693 Sodium works compared to a placebo in resolving NASH without worsening liver fibrosis after 52 weeks of treatment in patients with non-cirrhotic NASH and a specific genetic marker.
  • Who can participate in this study? Participants must be adults aged 18-75 with non-cirrhotic NASH, have the PNPLA3 rs738409 148M genetic marker, and meet specific criteria for NASH severity and liver fibrosis stage.
  • How is AZD2693 Sodium administered? AZD2693 Sodium is given as a solution for injection, administered subcutaneously (under the skin).
  • What are the main things the study will measure? The study will primarily measure the resolution of NASH without worsening liver fibrosis. It will also assess improvements in liver fibrosis, changes in NASH Activity Score (NAS), and overall safety and tolerability of the drug.
  • How long does the treatment last in this trial? The treatment period in this trial lasts for 52 weeks (about one year).

Ongoing Clinical Trials on Azd2693 Sodium

  • Study on AZD2693 for Adults with Non-Cirrhotic Non-Alcoholic Steatohepatitis and PNPLA3 Genetic Marker

    Not recruiting

    1
    Investigated drugs:
    Germany Italy Spain

Glossary

  • Non-alcoholic steatohepatitis (NASH): A type of fatty liver disease not caused by alcohol, characterized by inflammation and liver cell damage, which can lead to fibrosis and cirrhosis.
  • Fibrosis: The formation of excess fibrous connective tissue in the liver, which can occur as a result of injury or long-term inflammation.
  • PNPLA3 rs738409 148M risk allele: A specific genetic variation associated with an increased risk of developing and progressing NASH.
  • Liver biopsy: A medical procedure where a small sample of liver tissue is removed and examined under a microscope to diagnose liver conditions.
  • NASH CRN fibrosis staging system: A standardized method used to assess and grade the severity of liver fibrosis in NASH patients.
  • NAS (NAFLD Activity Score): A scoring system used to assess the severity of non-alcoholic fatty liver disease (NAFLD) and NASH, considering factors like steatosis, inflammation, and ballooning.
  • Subcutaneous injection: A method of administering medication by injecting it into the layer of tissue between the skin and muscle.
  • Placebo: An inactive substance that looks like the real medicine but has no therapeutic effect, used as a control in clinical trials.
  • Double-blind study: A type of clinical trial where neither the participants nor the researchers know who is receiving the actual treatment and who is receiving a placebo.
  • Randomized controlled trial: A study design where participants are randomly assigned to different treatment groups to compare outcomes.

References

  1. http://clinicaltrials.eu/trial/study-on-azd2693-for-adults-with-non-cirrhotic-non-alcoholic-steatohepatitis-and-pnpla3-genetic-marker/