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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06577090 | Study to Evaluate the Effect on Obesity of QW Nimacimab and QW Nimacimab Co-administered With Semaglutide vs Placebo | PHASE2 | ACTIVE NOT_RECRUITING | 136 | — | — | Aug 22, 2024 | Feb 28, 2027 | Jan 14, 2026 | 16 | United States |
Percent of participants who have a reduction in body weight
Nature, frequency and severity of treatment-emergent adverse events, including serious adverse events and adverse events of special interest
| Arm | Type | Description |
|---|---|---|
| Nimacimab injection | EXPERIMENTAL | Nimacimab injection 200 mg |
| Nimacimab placebo injection | PLACEBO_COMPARATOR | Matching nimacimab placebo injection |
| Semaglutide injection + Nimacimab injection 200 mg | EXPERIMENTAL | Semaglutide injection administered according to dose escalation described in semaglutide prescribing information plus concomitant administration of Nimacimab Injection 200 mg |
| Semaglutide injection + Nimacimab placebo injection | ACTIVE_COMPARATOR | Semaglutide injection administered according to dose escalation described in semaglutide Prescribing Information plus concomitant administration of Nimacimab Injection or matching placebo injection |
| Open-label 300 mg Nimacimab injection (study extension) | EXPERIMENTAL | Weekly nimacimab injection 300 mg open-label (study extension) |
| Name | Type | Description |
|---|---|---|
| Nimacimab injection | BIOLOGICAL | Nimacimab injection 200 mg |
| Nimacimab placebo injection | BIOLOGICAL | matching nimacimab placebo injection |
| semaglutide injection | COMBINATION_PRODUCT | semaglutide injection 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg + nimacimab 200 mg |
| Nimacimab 300 mg injection | BIOLOGICAL | Nimacimab injection 300 mg |
Inclusion Criteria: 1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 2. Participants must be at least 18 years of age or the legal age of consent in the jurisdiction in which...