Clinical Trials | A Randomized, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Paltusotine in Adults with Carcinoid Syndrome due to Well-Differentiated Neuroendocrine Tumors

The University of Virginia seeks adults ages 18 ages and over with Carcinoid Syndrome for a research study. The purpose of the study is to see if an investigational drug called Paltusotine can reduce carcinoid syndrome symptoms (such as flushing and diarrhea) compared to placebo (an inactive material in a tablet that looks identical to the study drug). The study will also look at its safety and tolerability. You may be eligible for this study if you have Carcinoid Syndrome requiring medical treatment and show symptoms of flushing. This study includes a screening period of 2-11 weeks, a 16-week treatment period, and a follow-up period of 4 weeks. Study involves randomization into either the Paltusotine group or the placebo group. Both groups will take two tablets once a day. Study participants will have study visits at weeks 2, 4, 8, 12, and 16 after Day 1 randomization visit. Study visits may include collecting vital signs, laboratory tests, EECG, pregnancy tests, and other examinations, such as echocardiogram and gallbladder ultrasound. After the initial randomized controlled period, patients may be eligible to receive the study drug for up to 2 years in the open-label extension period. Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance.