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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03707990 | A Research Study of NNC0165-1875 Alone or Together With Semaglutide in People Who Are Overweight or Obese | PHASE1 | COMPLETED | 88 | — | — | Oct 15, 2018 | Aug 13, 2019 | Sep 6, 2019 | 1 | United States |
Count of adverse events.
| Arm | Type | Description |
|---|---|---|
| NNC0165-1875 | EXPERIMENTAL | Participants will receive NNC0165-1875 alone in cohorts 1-5 (part 1) and NNC0165-1875 along with semaglutide in cohorts 6-11 (part 2). |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo alone in cohorts 1-5 (part 1) and placebo along with semaglutide in cohorts 6-11 (part 2). |
| Name | Type | Description |
|---|---|---|
| NNC0165-1875 | DRUG | Participants will receive a single dose of subcutaneous (s.c.) NNC0165-1875 injection. The planned doses of NNC0165-1875 are as following: cohort 1 and 7: 0.1 mg, cohort 2 and 8: 0.3 mg, cohort 3 and 9: 0.6 mg, cohort 4 and 10: 1.2 mg, cohort 5 and 11: 2.4 mg and cohort 6: 0.03 mg. |
| Placebo (NNC0165-1875) | DRUG | Participants will receive a single dose of s.c. placebo injection. |
| Semaglutide | DRUG | Participants will receive a single dose of s.c. semaglutide 0.25 mg injection. |
Inclusion Criteria: * Males, aged 18-55 years (both inclusive) at the time of signing informed consent * Body mass index (BMI) between 25.0 and 34.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator * Body weight greater than or ...