Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07029412 | Study to Evaluate Efficacy and Dose Response of Imapextide (STEADI) | PHASE2 | RECRUITING | 10 | — | — | Aug 26, 2025 | Jan 26, 2026 | Dec 17, 2025 | 4 | United States |
| NCT06036784 | Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of MBX 1416 in Healthy Subjects | PHASE1 | COMPLETED | 69 | — | — | Sep 18, 2023 | Dec 5, 2024 | Dec 12, 2024 | 1 | United States |
| 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...