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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04521738 | First-in-human Study to Assess Safety and Tolerability of a Single Subcutaneous Dose of SAR441255 in Lean to Overweight Subjects | PHASE1 | COMPLETED | 48 | — | — | Apr 25, 2019 | Sep 26, 2019 | Sep 22, 2025 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| SAR441255 | EXPERIMENTAL | Single dose, subcutaneous, escalating dose |
| Placebo | PLACEBO_COMPARATOR | Single dose, subcutaneous, matched volume |
| Name | Type | Description |
|---|---|---|
| SAR441255 | DRUG | Pharmaceutical form:solution for injection Route of administration: subcutaneous |
| placebo | DRUG | Pharmaceutical form:solution for injection Route of administration: subcutaneous |
Inclusion criteria : * Male and female subjects, between 18 and 55 years of age, inclusive * Body Mass Index ≥20 and ≤30 kg/m2 * Body weight between 65 and 90 kg, inclusive * No concomitant medication * Fasting Plasma Glucose \<126 mg/dL * Hemoglobin A1c \<6.5% * Triglycerides \<300 mg/dL * Low-den...