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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06719011 | A Study on How NNC0174-1213 Works in People With Overweight or Obesity. | PHASE1 | RECRUITING | 177 | — | — | Dec 3, 2024 | May 17, 2026 | May 25, 2025 | 2 | United States |
Number of events
Number of events
| Arm | Type | Description |
|---|---|---|
| Part A: NNC0174-1213 (SD1-SD5) | EXPERIMENTAL | Part A: Single ascending dose (SAD) of NNC0174-1213 will be administered in cohorts 1-5. |
| Part A: Cagrilintide (SDA and SDB) | EXPERIMENTAL | Part A: Single ascending dose (SAD): Cagrilintide SDA will be administered in cohort 1 and 2. Cagrilintide SDB will be administered in cohort 3 and 4. |
| Part A: Placebo | EXPERIMENTAL | Part A: Single ascending dose (SAD) of placebo will be administered to cohorts 1-5. |
| Part B: NNC0174-1213 (MD1-MD5) | EXPERIMENTAL | Part B: Multiple ascending doses (MAD) of NNC0174-1213 will be administered to cohorts 1-5. |
| Part B: Cagrilintide (MDA) | EXPERIMENTAL | Part B: Multiple ascending doses (MAD) of Cagrilintide MDA will be administered to cohorts 1-5. |
| Part B: Placebo | EXPERIMENTAL | Part B: Multiple ascending doses (MAD) of placebo will be administered to cohorts 1-5. |
| Name | Type | Description |
|---|---|---|
| NNC0174-1213 A | DRUG | Participants will be randomized to receive NNC0174-1213 A administered as subcutaneous (s.c. under the skin) injection. Single ascending dose (SAD) will be injected for Part A cohorts and multiple ascending doses (MAD) will be injected for Part B cohorts. |
| Cagrilintide B | DRUG | Participants will be randomized to receive Cagrilintide B administered as subcutaneous (s.c. under the skin) injection. Single ascending dose (SAD) will be injected for Part A cohorts and multiple ascending doses (MAD) will be injected for Part B cohorts. |
| Placebo A (NNC0174 1213 A) | DRUG | Participants will be randomized to receive Placebo administered as subcutaneous (s.c. under the skin) injection. Single ascending dose (SAD) will be injected for Part A cohorts and multiple ascending doses (MAD) will be injected for Part B cohorts. |
Inclusion Criteria: * Male. * Age 18-55 years (both inclusive) at the time of signing the informed consent. * Body mass index (BMI) between 27.0 and 34.9 kilogram per meter square (kg/m\^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigat...