ZALFERMIN

Clinical trials are investigating ZALFERMIN in people with alcohol-related liver disease. These studies look at whether it can help with liver damage and liver function, and they compare it with placebo and other study drugs. The main focus is on safety and how well the treatments work in adults with this condition.

Table of contents

Trial overview

This clinical trial studied ZALFERMIN in people with alcohol-related liver disease, a liver condition linked to alcohol use.[1] The study was interventional, which means researchers assigned treatments and then compared outcomes.[1] It was a Phase 2 trial and was marked as completed.[1]

Condition and population studied

The trial focused on adults with alcohol-related liver disease.[1] The study data do not give more detailed entry rules, so the exact participation criteria are not fully listed here.[1] In simple terms, the study looked at people who already had liver problems related to alcohol use.[1]

Treatments being tested

The trial compared ZALFERMIN with other study treatments and with placebo, which is an inactive treatment used for comparison.[1] The listed interventions included cagrilintide, semaglutide, combinations of these drugs, placebo, and ZALFERMIN given by subcutaneous injection, meaning under the skin.[1] The study summary says the goal was to test these treatment options alone and in combination versus placebo for liver damage and function.[1]

Trial phase and design

This was a Phase 2 study, which is a mid-stage trial that looks more closely at whether a treatment may work and keeps checking safety.[1] The study type was interventional, so the research team actively assigned the study treatments instead of only observing people.[1] The enrollment was 287 people, showing a moderate-size trial group for this type of research.[1]

What the trial measures

The main outcome was the change in Enhanced Liver Fibrosis (ELF).[1] ELF is a blood test-based measure used to help estimate liver fibrosis, which means scarring in the liver.[1] By tracking this change, the study aimed to see whether the treatments could improve or affect liver damage and liver function.[1]

What this means for patients

For patients, this trial shows that ZALFERMIN is being explored as part of research for alcohol-related liver disease, not as a routine treatment described in this data.[1] The study looked at whether ZALFERMIN and related treatment combinations could help with liver injury compared with placebo.[1] Because the trial is completed, the next step would be to review the results to understand whether the treatment approach was helpful.[1]

Trial ID Phase Condition studied Status Enrollment
2023-508170-28-00 Phase 2 Alcohol-related liver disease Completed 287

Ongoing Clinical Trials on ZALFERMIN

  • A study testing NNC0194-0499, cagrilintide, and semaglutide alone or combined to treat liver damage in people with alcohol-related liver disease

    Not recruiting

    2 1
    Investigated diseases:
    Bulgaria Czechia Denmark France Germany Greece +4

Glossary

  • Alcohol-related liver disease: A liver condition caused by alcohol use. It can lead to liver damage and scarring.
  • Phase 2: A stage of clinical research that looks more closely at whether a treatment may work and continues to monitor safety.
  • Interventional study: A study where researchers give a treatment or placebo and then compare results.
  • Placebo: An inactive treatment that looks like the study drug. It helps researchers compare results fairly.
  • Subcutaneous: Given under the skin, usually by injection.
  • Enhanced Liver Fibrosis (ELF): A test used to estimate liver fibrosis, which means scarring in the liver.
  • Liver fibrosis: Scarring of the liver. More scarring can mean more serious liver disease.
  • Liver damage: Injury to the liver that can affect how well it works.
  • Efficacy: How well a treatment works in a study.
  • Enrollment: The number of people planned or included in a trial.

References

  1. https://clinicaltrials.gov/study/2023-508170-28-00