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Avexitide in Post-Bariatric Hypoglycemia - Clinical Trial

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What is the Purpose of this Study?

We are doing this study to find out if an experimental drug called avexitide (the study drug) is a safe and effective option to prevent or reduce the severity of hypoglycemia episodes for people who have post-bariatric hypoglycemia following Roux-en-Y gastric bypass.

What is the Condition Being Studied?

Hypoglycemia After Bariatric and Gastric Surgery

Who Can Participate in the Study?

Adults ages 18+ who:

Had a Roux-en-Y gastric bypass procedure at least one year ago
Are diagnosed with post-bariatric hypoglycemia
Have a body mass index (BMI) of 40 or lower
Have not had any significant weight gain or weight loss for at least 2 months before joining the study

For more information, contact the study team at shawn.greene@duke.edu.

Grupo etario

Adultos

What is Involved?

If you choose to join this study, you participation last for up to 58 weeks and will include:

A screening period of up to 6 weeks, during which there will be a 3-week run-in period that will record your hypoglycemic episodes (you'll use a continuous glucose monitor)
A 16-week, double-blind period (you will get a random assignment to take either the study drug or a placebo at home)
After the double-blind period is done, there will be a 32-week open label extension where you will take the study drug at home regardless fo your assignment during the double-blind period
You will keep an electronic diary of all of your study drug injections, and you will also record any hypoglycemic episodes in this diary

Your participation will end when you come in for a follow-up visit around 4 weeks after you stop taking the study drug.

Study Details

Full Title

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Avexitide in Participants with Post-Bariatric Hypoglycemia

Principal Investigator