What is the study medicine?
The study medicine, pemvidutide, is similar to two natural hormones, glucagon-like peptide-1 (GLP-1) and glucagon. The body naturally makes these hormones to regulate metabolism and food intake. These processes are usually disrupted in people who have NASH.
Why is this study being conducted?
The purpose of the IMPACT-NASH Trial is to evaluate how well pemvidutide works as a treatment for people living with NASH. This will be measured by assessing liver health in study participants before, during, and after treatment to see if pemvidutide is a better treatment than placebo (a salt-water solution that does not contain pemvidutide).
Clinical researchers will also explore how participants feel while they are taking pemvidutide or if they experience side effects. If side effects are observed, standard medicines could be given to help reduce the symptoms. The dose of study medicine could be temporarily reduced or the treatment could be temporarily paused, which may help the patient have fewer side-effects when the medicine is resumed at the full dose.
Will I receive the study medicine?
The majority of participants in the IMPACT-NASH Trial will receive pemvidutide, with the others receiving placebo. Neither the study team nor the participant will know what they are receiving.
What is a “study medicine”?
A study medicine, also know as an investigational medicine, has not been approved by regulatory authorities like the US Food and Drug Administration (FDA). Because of this, the study medicine can only be used in clinical research studies like the IMPACT-NASH Trial.