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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06496217 | Safety and Pharmacokinetics Study of MBX 2109 in Adult Subjects With Normal and Impaired Renal Function | PHASE1 | COMPLETED | 25 | — | — | Jun 13, 2024 | Sep 4, 2025 | Oct 28, 2025 | 3 | United States |
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
| Arm | Type | Description |
|---|---|---|
| Single 900 µg dose of MBX 2109 | EXPERIMENTAL | A single, 900 µg dose of MBX 2109 will be administered subcutaneously in the abdomen |
| Name | Type | Description |
|---|---|---|
| MBX 2109 | DRUG | Group 1: Subjects with mild renal impairment (eGFR ≥ 60 and \< 90 mL/min) |
Inclusion Criteria (all participants) 1. Willingness to adhere to the Protocol requirements as evidenced by a signed and dated informed consent form (ICF) 2. Subject is, as stated and in the opinion of the Investigator, willing and able to comply with the study drug regimen and all other study proc...