This study involves people with Short Bowel Syndrome, which is a condition where a large part of the small intestine is missing or has been removed, making it difficult for the body to absorb enough nutrients and fluids from food. People with this condition often need parenteral support, which means they receive nutrition and fluids directly into their veins through an intravenous line because their remaining intestine cannot absorb what they need from eating and drinking normally. This type of support is also called intestinal failure, meaning the intestine cannot work well enough on its own to maintain proper nutrition and hydration.
The study will test a medication called glepaglutide, which is given as an injection under the skin twice each week. Some participants will receive glepaglutide while others will receive placebo. The purpose of this study is to confirm whether glepaglutide can help reduce the amount of parenteral support that people with short bowel syndrome need each week. The study will look at whether the medication can decrease the volume of nutrition and fluids that must be given through the veins, and possibly help some people reduce the number of days per week they need this support or even stop needing it completely.
The study is divided into two parts. In the first part, which lasts 24 weeks, participants will be randomly assigned to receive either glepaglutide or placebo, and neither the participants nor the doctors will know which treatment is being given. This part will continue for up to 52 weeks for some measurements. After this, there will be a longer period where all participants will receive glepaglutide and everyone will know they are receiving the actual medication. During the study, doctors will measure changes in the weekly volume of parenteral support needed and track how participants feel about their condition overall.
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