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Also known as MBX 1416 (Part A), MBX 1416 (INN imapextide)
MBX 1416 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| MBX 1416 (INN imapextide) | EXPERIMENTAL | Single subcutaneous administration at different dose levels |
| MBX 1416 (Part A) | EXPERIMENTAL | Single ascending subcutaneous (SC) doses |
| MBX 1416 (Part B) | EXPERIMENTAL | Repeated ascending subcutaneous (SC) doses |
| Placebo | PLACEBO_COMPARATOR | - |
| MBX 1416 (Part C) | EXPERIMENTAL | Single subcutaneous (SC) dose of MBX 1416, single dose of rosuvastatin and acetaminophen. |
| Name | Type | Description |
|---|---|---|
| MBX 1416 (INN imapextide) | DRUG | A single subcutaneous injection of MBX 1416 at a low dose and a high dose approximately 2 weeks apart. |
| MBX 1416 (Part A) | DRUG | Single Ascending subcutaneous (SC) dose of MBX 1416: 10mg, 30mg,100mg, 200mg |
| MBX 1416 (Part B) | DRUG | Repeated ascending subcutaneous (SC) doses of MBX 1416: 10mg, 30mg, 100mg |
| Placebo | DRUG | Single dose or repeated subcutaneous (SC) dose of placebo. |
| MBX 1416 (Part C) | DRUG | Single subcutaneous (SC) dose of MBX 1416 and the single dose of rosuvastatin and acetaminophen pharmacokinetics. The doses selected for MBX 1416 in Part C will not exceed a dose of 200mg. |
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 (sympto...
MBX 1416 is being developed for postbariatric hypoglycemia, a condition of low blood sugar that can occur after bariatric surgery. It is an investigational therapy and has not been approved for commercial use. MBX Biosciences is studying it in adults aged 18 years and older.
MBX 1416 is developed by MBX Biosciences, Inc., which trades on the Nasdaq under the ticker MBX. The company is advancing the candidate for postbariatric hypoglycemia within the metabolic therapeutic area.
MBX 1416 is in Phase 2 development. Two clinical trials have been completed: a Phase 2 efficacy and dose response study and a Phase 1 safety, tolerability, pharmacokinetic and pharmacodynamic study. No trials are currently active. The drug remains investigational and has not been approved by the FDA.
MBX 1416 has been evaluated in two completed trials. NCT07029412, also called STEADI, was a Phase 2 study of efficacy and dose response in postbariatric hypoglycemia with 20 participants. NCT06036784 was a Phase 1 safety, tolerability, pharmacokinetic and pharmacodynamic study in 69 healthy subjects. Both were conducted in the United States.
Yes. MBX 1416 is also known as imapextide, its International Nonproprietary Name. The Phase 2 study is listed under the name imapextide, and earlier materials refer to MBX 1416 (Part A). All of these names refer to the same investigational compound being developed by MBX Biosciences.
The MBX 1416 trials used randomized, double-blind, placebo-controlled designs. The Phase 2 STEADI study enrolled 20 adults with postbariatric hypoglycemia, while the Phase 1 study enrolled 69 healthy volunteers. Together the two completed trials enrolled 89 participants, all aged 18 years or older, and both studies were conducted in the United States.