Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NNC9204-1177 · 2 trials · 4 indications
ng\*h/mL
ng\*h/mL
ng\*h/mL
ng\*h/mL
ng\*h/mL
| Arm | Type | Description |
|---|---|---|
| NNC9204-1177 and cocktail of approved drugs | EXPERIMENTAL | - |
| NNC9204-1177 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| NNC9204-1177 | DRUG | Increasing doses of NNC9204-1177 administered s.c. (subcutaneously, under the skin) in the stomach area once-weekly for 11 weeks |
| Cocktail of 5 already approved drugs | DRUG | 5 medicines as tablets, capsules or syrup to be taken with water on Day 1 and Day 78 of the study |
| Placebo | DRUG | A single dose administered subcutaneously ( s.c. under the skin) |
Inclusion Criteria: * Male or female, aged 18-60 years (both inclusive) at the time of signing informed consent. * Body mass index (BMI) between 23.0 and 29.9 kg/m\^2 (both inclusive) at screening. * Considered to be generally healthy based on the medical history, physical examination, and the resu...
NNC9204-1177 is an investigational small molecule developed by Novo Nordisk A/S for overweight and obesity, within the metabolism and nutrition disorder area. It has been studied in Phase 1 clinical trials in healthy volunteers who were overweight or had obesity. It is not an approved medicine.
NNC9204-1177 is being developed for overweight and obesity, falling under metabolism and nutrition disorders. Clinical testing has involved healthy adult volunteers who were overweight or had obesity. Because it remains investigational, it is not authorized for any therapeutic use outside of clinical research.
NNC9204-1177 is developed by Novo Nordisk A/S, the Danish pharmaceutical company whose shares trade under the ticker NVO. Novo Nordisk sponsored the Phase 1 trials of the compound conducted in the United States.
NNC9204-1177 is in Phase 1 development. Two Phase 1 trials have been completed, including a first human dose trial and a drug interaction study, and no later-phase trials have been registered. It is an investigational agent and has not been approved by the FDA.
Two completed Phase 1 trials have studied NNC9204-1177. NCT02941042 was a first human dose trial of single doses in overweight or obese male subjects, enrolling 49 participants. NCT04059367 examined how the study medicine affects blood levels of other medicines in healthy people, enrolling 45 participants in the United States.
The NNC9204-1177 trials were randomized, double blind, and placebo controlled. NCT02941042 evaluated safety, tolerability, and pharmacokinetics of single doses in overweight or obese men, while NCT04059367 assessed effects on blood levels of other medicines in healthy volunteers. Both Phase 1 studies are complete.