Clinical Trials Directory
This study has several parts. First, there is a screening period that can last up to 42 days. After that, people are randomly placed into different groups to start treatment. The main part of the study lasts 24 weeks, and doctors will check how the heart is doing at the end of that time. If someone finishes the first part and is still taking the study medicine, they may be placed into a new group for another 24 weeks of treatment. After that, there is a safety check that lasts 12 weeks to make sure everything is okay after the medicine ends.
We are doing this study to find out if an experimental drug called pegozafermin (the study drug) is a safe and effective option for people with Metabolic Dysfunction Associated Steatohepatitis (MASH).
This study lasts for about 41 weeks. It starts with a screening period, followed by around 6 months of taking either the study medicine or a placebo, and ends with a follow-up visit. People who join will be randomly chosen to get either a low dose or high dose of the medicine called PKN605, or a placebo, which is a pill that does not have any medicine in it. During the study, participants will go to the clinic regularly. They will wear a heart monitor patch, use a small device at home to check their heart, and have blood tests and other health checks. These tests help doctors learn how the medicine works and if it is safe.
This study has two groups, and you will have an equal chance of being in either one. In Group 1, people get the usual treatment for advanced prostate cancer. This includes hormonal therapy, which can be given as a shot or as pills, and apalutamide, which is taken as four pills once a day. In Group 2, people get a chemotherapy drug called docetaxel along with the usual hormonal therapy and apalutamide. Docetaxel is given through a vein every three weeks for up to six doses. People in this group also get steroids through an IV on the day they receive docetaxel to help reduce side effects.
Participants will be randomly assigned to receive either standard treatment or standard treatment plus the study drug vorasidenib. All participants will receive radiation therapy followed by temozolomide. After the first year, participants will continue taking either vorasidenib or a placebo until their tumor worsens or their doctor recommends stopping treatment. The medications are taken by mouth once a day.
Participants will either be monitored with regular scans or receive the study drug atezolizumab, given by IV infusion or injection every 21 days for up to 1 year. Treatment will continue unless the cancer returns or side effects become too severe. Researchers will compare whether the study drug helps prevent the cancer from coming back compared with monitoring alone.