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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 20 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBX 1416 (INN imapextide) | Experimental | Single subcutaneous administration at different dose levels |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MBX 1416 (INN imapextide) | Drug | A single subcutaneous injection of MBX 1416 at a low dose and a high dose approximately 2 weeks apart. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline to post-treatment in glucose nadir during a standardized MMTT following different dose levels of MBX 1416. | 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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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MBX Biosciences Investigational Site | Aurora | Colorado | 80045 | United States | ||
| MBX Biosciences Investigational Site |
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| Morehead City |
| North Carolina |
| 28557 |
| United States |
| MBX Biosciences Investigational Site | Knoxville | Tennessee | 37920 | United States |
| MBX Biosciences Investigational Site | San Antonio | Texas | 78229 | United States |