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.
Who Can Participate?
Eligibility
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
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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
Locations
Duke Regional Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
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
Keri
Seymour
Protocol Number
PRO00117750
NCT ID
NCT06747468
Phase
III
Enrollment Status
Pending Open to Enrollment