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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07429045 | A Trial to Assess the Effect of Kidney Impairment on How AMG 133 is Absorbed, Broken Down, and Eliminated by the Body | PHASE1 | COMPLETED | 44 | — | — | Mar 11, 2025 | Nov 21, 2025 | Feb 24, 2026 | 5 | United States |
| Arm | Type | Description |
|---|---|---|
| Group 1: Normal renal function | EXPERIMENTAL | Participants with an estimated glomerular filtration rate (eGFR) of ≥ 90 mL/min will receive a single dose of AMG 133 as a SC injection. |
| Group 2: Mild renal impairment | EXPERIMENTAL | Participants with an eGFR of 60 to \< 90 mL/min will receive a single dose of AMG 133 as a SC injection. |
| Group 3: Moderate renal impairment | EXPERIMENTAL | Participants with an eGFR of 30 to \< 60 mL/min will receive a single dose of AMG 133 as a SC injection. |
| Group 4: Severe renal impairment and kidney failure not receiving hemodialysis | EXPERIMENTAL | Participants with an eGFR of \< 30 mL/min will receive a single dose of AMG 133 as a SC injection. |
| Group 5: Kidney failure receiving hemodialysis | EXPERIMENTAL | Participants with an eGFR of \< 15 mL/min will receive a single dose of AMG 133 as a SC injection. |
| Name | Type | Description |
|---|---|---|
| AMG 133 | DRUG | Participants will receive one dose of AMG 133 as a SC injection. |
Inclusion Criteria All Participants in Groups 1 to 5 1. Male or female, of any race, between 18 and 75 years of age, inclusive. a. Females must not be pregnant or lactating. 2. Body mass index \> 22.0 kg/m2. 3. Eligible participants classified based on eGFR at screening and established need fo...