The purpose of this study is to assess the preliminary efficacy of single SC administration of MBX 1416 at different dose levels in patients with PBH
This is a Phase 2a, open-label, exploratory study to evaluate preliminary efficacy of SC MBX 1416 in patients with PBH. Approximately 10 patients aged 18 to 75 (inclusive) years with history of hypoglycemia following Roux-en-Y or sleeve gastrectomy will be included in the study. Participants will undergo 3 mixed-meal tolerance tests, one at baseline and again 48 hours after each MBX 1416 administration, to evaluate the effect of MBX 1416 on increasing post-prandial glucose nadir. MBX 1416 effect in reducing post-prandial insulin and C-peptide peaks will also be evaluated
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
A single subcutaneous injection of MBX 1416 at a low dose and a high dose approximately 2 weeks apart.
MBX Biosciences Investigational Site
Aurora, Colorado, United States
RECRUITINGMBX Biosciences Investigational Site
Morehead City, North Carolina, United States
RECRUITINGMBX Biosciences Investigational Site
Knoxville, Tennessee, United States
Changes from baseline to post-treatment in glucose nadir during a standardized MMTT following different dose levels of MBX 1416.
Time frame: The duration of the study will be approximately 67 days from screening to end of study (EoS) for any given participant
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MBX Biosciences Investigational Site
San Antonio, Texas, United States
RECRUITING