Clinical trials are a crucial part of learning more about certain diseases, as well as better understanding the impact of various therapeutic options. For example, a clinical trial can help researchers learn about the safety, efficacy, and tolerability of new treatments. In a late November 2022 news release, clinical-stage pharmaceutical company 9 Meters Biopharma, Inc. (“9 Meters”) shared the design of the Phase 3 VIBRANT 2 clinical trial. The trial will evaluate vurolenatide for adult patients living with short bowel syndrome (SBS).

Vurolenatide is an investigational long-acting GLP-1 receptor agonist that is administered via injection. DiaTribe Learn explains that GLP-1 is a hormone produced in the small intestine that:

stimulates insulin secretion (which then allows cells to take up glucose) and inhibits glucagon secretion (which prevents more glucose from going into the bloodstream) to lower blood sugar levels. GLP-1 also slows stomach emptying.

In those with SBS, part of the intestine that secrets GLP-1 may be removed or shortened. As a result, food and fluid may move too quickly through the body. A GLP-1 agonist can help increase the amount of GLP-1, helping to slow this process in SBS and contribute to better nutrient and fluid absorption.

Prior studies of vurolenatide have shown that the treatment increases fluid and nutrient absorption. 9 Meters hopes that the Phase 3 study will expand on their understanding of vurolenatide’s benefits, as well as reaffirm prior safety, efficacy, and tolerability data.

The U.S. Institutional Review Board (IRB) approved the study design, which also included input from the FDA. Altogether, there will be 50 clinical sites and an estimated 105 participants. Patients who require parenteral support 3+ times per week, or who require it less than 3 times per week, will both be included in the trial. Enrolled patients will receive 50mg of subcutaneous vurolenatide every two weeks for a 12-week period. Ultimately, the research team hopes to determine how vurolenatide affects total stool output, nutrient and fluid absorption, and the need for parenteral support.

What is Short Bowel Syndrome (SBS)?

Short bowel syndrome, or short gut syndrome, is a rare and complex disorder that occurs when a portion of the small intestine is either missing (due to surgical removal) or poorly functioning. The small intestine could be removed due to injury, birth defects, chemotherapy or radiation treatment, or conditions such as cancer or Crohn’s disease. Regardless of the cause, SBS prevents the adequate absorption of fluid and nutrients. An estimated 3 in every one million people has SBS.

Symptoms vary in severity; some people are affected mildly or moderately, while others experience severe symptoms. Without proper treatment, SBS can have life-threatening complications. Symptoms associated with SBS can, but do not always, include:

• Persistent diarrhea
• Foul-smelling stools
• Nausea and vomiting
• Unintended weight loss
• Anemia (low red blood cell count)
• Muscle cramping and spasms
• Easy bruising
• Dehydration and malnutrition
• Lethargy
• Swelling of the lower extremities
• Abdominal cramping and bloating
• Heartburn
• Excessive gas
• Food intolerances
• Fatty liver
• Gallstones and/or kidney stones