What is the IMPACT-NASH Trial?
IMPACT is a phase 2 (mid-stage) clinical trial designed to evaluate how well pemvidutide compared to placebo (an inactive injection such as salt water), improves liver inflammation and scarring in people living with nonalcoholic steatohepatitis or NASH (also known as metabolic dysfunction-associated steatohepatitis or MASH). The study will also assess the safety of pemvidutide, including side effects and how people feel while they are receiving treatment.
Who can join the IMPACT-NASH Trial?
You may be eligible to join the trial if you meet certain requirements as determined by a qualified healthcare professional. It is possible you could qualify if you have been told you have any of the following conditions:
- Nonalcoholic steatohepatitis (NASH), also known as metabolic dysfunction-associated steatohepatitis (MASH).
- Nonalcoholic fatty liver disease (NAFLD), also known as metabolic dysfunction-associated steatotic liver disease (MASLD)
- Liver fibrosis due to the above conditions
- Cirrhosis due to the above conditions
Age range: 18 through 75 years of age
* Other study requirements will apply, as will be explained by the study doctor at the study site
What will happen during the study?
Participation in IMPACT study lasts approximately 15 months. Study participants can expect the following:
Informed Consent →
Review & sign the Informed Consent Form.
Receive study-related health assessments to confirm you qualify for the study.
Treatment Period →
Receive the study drug or placebo administered subcutaneously once a week for 48 weeks. Throughout the trial, your study team will monitor your health and will provide you with regular counseling.
Follow-up Period →
Safety follow-up period lasts 1 month: Complete a follow-up visit to assess your health approximately 1 month after completing treatment.
Participation in a clinical study is voluntary. You can ask any questions you have, and you may leave the study at any time, for any reason.
Visit clinicaltrials.gov to learn more about the IMPACT-NASH Trial.