New shot aims to stop dangerous sugar crashes after gastric bypass
NCT ID NCT07029412
First seen Jun 24, 2026 · Last updated Jul 02, 2026 · Updated 2 times
Summary
This study tests a new drug called MBX 1416 in 10 people who have low blood sugar episodes after weight loss surgery. Participants receive two injections of the drug, a low dose and a high dose, about two weeks apart. The goal is to see if the drug can raise the lowest blood sugar level during a standard meal test, which could help control this condition.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MBX 1416 (imapextide)
- What this could lead to
- If this works, it could point toward a new treatment to prevent dangerous blood sugar drops after weight loss surgery, improving daily life and safety.
- What could go wrong
- This is a very small, early-phase study with only 10 participants, so results may not apply to everyone. The drug is given only twice, and its long-term safety and effectiveness are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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20 people
The number who actually took part.
- Started
-
Aug 2025
- Finished
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May 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Participant must be ≥18 to ≤75 years of age at the time of signing the informed consent. 2. Participants must have undergone RYGB or SG surgery at least 12 months prior to study entry. 3. Participants should have a documented history of PBH, defined as Whipple's triad (symptomatic hypoglycemia, capillary glucose ≤54 mg/dL, with symptom resolution by carbohydrate administration) and a minimum of 1 symptomatic hypoglycemic episode per month by patient report. 4. Participants who are either treatment naïve or who are no longer using (i.e., have discontinued as part of their usual medical care) agents known to interfere with glucose metabolism at the time of screening. 5. Participants must have a body mass index (BMI) \<45 kg/m2 at screening. 6. Must have signed informed consent. Exclusion Criteria: 1. History of, or currently active, significant illness or medical disorders that in the opinion of the investigator may preclude participants from participating in the study. 2. Currently on-going type II diabetes mellitus. 3. History of hypoglycemia prior to bariatric surgery. 4. History of insulinoma or other endogenous hyperinsulinemia illness (e.g., congenital hyperinsulinism).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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MBX Biosciences Investigational Site
Aurora, Colorado, 80045, United States
-
MBX Biosciences Investigational Site
Morehead City, North Carolina, 28557, United States
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MBX Biosciences Investigational Site
Knoxville, Tennessee, 37920, United States
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MBX Biosciences Investigational Site
San Antonio, Texas, 78229, United States
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