MBX 1416 for Post-Bariatric Hypoglycemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment, MBX 1416, for individuals experiencing low blood sugar (hypoglycemia) after certain types of weight-loss surgery. The goal is to evaluate the treatment's effectiveness when administered once under the skin at two different dose levels. Suitable candidates have undergone gastric bypass or sleeve surgery at least a year ago and regularly experience low blood sugar episodes that improve with carbohydrate intake. Individuals with ongoing type II diabetes or certain other medical conditions are ineligible. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial requires that participants are either not currently using or have already stopped using medications that affect glucose metabolism. If you're on such medications, you may need to stop them before joining the study.
Is there any evidence suggesting that MBX 1416 is likely to be safe for humans?
A previous study tested MBX 1416 on healthy volunteers, and it was generally well-tolerated, meaning most participants did not experience serious side effects. The study showed that MBX 1416 was safe for humans. Researchers closely monitored participants for any negative reactions, and the results were positive. This treatment is now under investigation in patients with low blood sugar after weight-loss surgery to assess its effectiveness for them as well.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for post-bariatric hypoglycemia, which often involve dietary changes and medications to manage blood sugar levels, MBX 1416 introduces a novel approach. It utilizes a new active ingredient called imapextide, administered subcutaneously, that could offer more precise control over hypoglycemia. Researchers are excited because this method targets the condition more directly, potentially providing quicker and more effective relief from symptoms than current options.
What evidence suggests that MBX 1416 might be an effective treatment for post-bariatric hypoglycemia?
Research shows that MBX 1416, which participants in this trial will receive, might help treat low blood sugar after weight-loss surgery, known as post-bariatric hypoglycemia (PBH). Earlier studies found that people generally tolerated MBX 1416 well, and it was considered safe. It appears to work by affecting GLP-1, a hormone that helps control blood sugar, suggesting it could help manage low blood sugar after surgery. Although data on its effectiveness for PBH is limited, its impact on GLP-1 is encouraging. Early results are promising, but further research is needed to confirm these findings.12678
Are You a Good Fit for This Trial?
This trial is for individuals who have developed low blood sugar levels (hypoglycemia) after undergoing weight loss surgery (bariatric surgery). Specific eligibility details are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo a mixed-meal tolerance test at baseline
Treatment
Single subcutaneous administration of MBX 1416 at 2 different dose levels, followed by mixed-meal tolerance tests 48 hours post-administration
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- MBX 1416
Find a Clinic Near You
Who Is Running the Clinical Trial?
MBX Biosciences
Lead Sponsor