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NNC0165-1562 · 2 trials · 4 indications
Count of adverse events.
| Arm | Type | Description |
|---|---|---|
| NNC0165-1562 + Semaglutide | EXPERIMENTAL | Participants will receive NNC0165-1562 and semaglutide once weekly for 20 weeks. |
| Placebo (NNC0165-1562) + Semaglutide | EXPERIMENTAL | Participants will receive placebo (NNC0165-1562) and semaglutide once weekly for 20 weeks. |
| NNC0165-1562 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| NNC0165-1562 | DRUG | Participants will receive NNC0165-1562 subcutaneous (s.c., under the skin) injection(s) once-weekly for 20 weeks. The dose will be escalated over 16 weeks to a final dose level that will be maintained for 4 weeks. |
| Semaglutide | DRUG | Participants will receive semaglutide s.c. injection(s) once-weekly for 20 weeks. The dose will be escalated over 16 weeks to a final dose level that will be maintained for 4 weeks. |
| Placebo (NNC0165-1562) | DRUG | Participants will receive placebo (NNC0165-1562) s.c. injection(s) once-weekly for 20 weeks. |
| placebo | DRUG | Administered subcutaneously (s.c., under the skin) single dose \[SD\]) or multiple dose \[MD\] with daily dosing. |
Inclusion Criteria: * Male or female, aged 19-55 years (both inclusive) at the time of signing informed consent. * Body mass index (BMI) between 27.0 and 39.9 kg/sqm (both inclusive) at screening. Obesity should be due to excess adipose tissue, as judged by the investigator. Exclusion Criteria: *...
NNC0165-1562 is an investigational small molecule developed by Novo Nordisk A/S for metabolism and nutrition disorders, specifically overweight and obesity. It is in Phase 1 clinical development and has been studied in two completed early-stage trials. It is not an approved medicine.
NNC0165-1562 is being studied for overweight and obesity, which fall under metabolism and nutrition disorders. Both of its completed Phase 1 trials enrolled adults who were overweight or obese, including one trial in otherwise healthy subjects. No approved use has been established.
NNC0165-1562 is developed by Novo Nordisk A/S, the Danish pharmaceutical company whose shares trade under the ticker NVO. Novo Nordisk sponsored both Phase 1 trials of the compound, which were conducted in the United States.
NNC0165-1562 is in Phase 1 clinical development. It has completed two Phase 1 trials, and no later-stage trials are listed. The compound is investigational and has not been approved by the FDA or any other regulator.
Two completed Phase 1 trials have studied NNC0165-1562. NCT02568306 was a first-in-human dose trial of single and multiple doses in 93 overweight to obese but otherwise healthy subjects. NCT03574584 studied NNC0165-1562 and semaglutide in 37 people who were overweight or obese.
Both Phase 1 trials of NNC0165-1562 were randomized, double-blind and controlled, enrolling 130 participants in total across the United States. NCT02568306 tested single and multiple ascending doses in healthy overweight to obese volunteers, while NCT03574584 evaluated NNC0165-1562 together with semaglutide in overweight or obese adults.