Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NNC0662-0419 · 6 trials · 3 indications
Measured as number of events.
Measured as percentage-point (%-point).
Measured as %-point.
Measured as %-point.
Measured as number of events.
Measured as percentage (%).
Measured as count of participants.
Measured as picograms per milliliter (h\*pg/mL)
Measured as h\*pg/mL
Measured in hours\*nanomoles per liter (h\*nmol/L).
Number of events
Number of events
| Arm | Type | Description |
|---|---|---|
| NNC0662-0419 | EXPERIMENTAL | Participants will receive NNC0662-0419 administered subcutaneously in a dose-escalation manner. |
| NNC0662-0419 placebo | PLACEBO_COMPARATOR | Participants will receive NNC0662-0419 placebo administered subcutaneously in a dose-escalation manner. |
| Semaglutide | EXPERIMENTAL | Participants will receive semaglutide administered subcutaneously in a dose-escalation manner. |
| Semaglutide placebo | PLACEBO_COMPARATOR | Participants will receive semaglutide placebo administered subcutaneously in a dose-escalation manner. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matched to their respective investigational medicinal product s.c. once weekly. |
| NNC0662-0419 with oral contraceptive (Altavera) and acetaminophen | EXPERIMENTAL | Participants will receive once-weekly subcutaneous NNC0662-0419, with multiple doses administered over the treatment period. An oral contraceptive will be administered as a number of tablets per treatment period, with dosing conducted under supervised conditions. In addition, a single dose of acetaminophen will be administered as part of a standardized meal during treatment period. |
| NNC0662-0419 (Dose 1) | EXPERIMENTAL | Participants will receive a single dose (SD) of NNC0662-0419 subcutaneously. |
| NNC0662-0419 (Dose 2) | EXPERIMENTAL | Participants will receive a SD of NNC0662-0419 subcutaneously. |
| NNC0662-0419 (Dose 3) | EXPERIMENTAL | Participants will receive a SD of NNC0662-0419 subcutaneously. |
| Part A: Single ascending dose (SAD) | EXPERIMENTAL | Participants will receive a single dose of any of the five different dose levels of NNC0662-0419 or matching placebo in a sequential manner with the dose increasing between cohorts. |
| Part B: Multiple ascending dose (MAD) | EXPERIMENTAL | Participants will receive NNC0662-0419 once-weekly for 4 weeks at any of the four different dose levels or matching placebo in a sequential manner with the dose increasing between cohorts. |
| Name | Type | Description |
|---|---|---|
| NNC0662-0419 | DRUG | NNC0662-0419 will be administered subcutaneously. |
| Semaglutide | DRUG | Semaglutide will be administered subcutaneously. |
| NNC0662-0419 Placebo | DRUG | Placebo matched to NNC0662-0419 will be administered subcutaneously. |
| Semaglutide placebo | DRUG | Placebo matched to semaglutide will be administered subcutaneously. |
| Placebo | DRUG | Placebo will be administered subcutaneously. |
| Oral contraceptive | DRUG | An oral contraceptive Altavera \[levonorgestrel (LN) 0.15 milligram (mg) and ethinyl estradiol (EE) 0.03 mg\] will be administered orally. |
| Acetaminophen | DRUG | A single dose of acetaminophen will be administered orally. |
| Placebo (NNC0662-0419) | OTHER | Participants will receive placebo matched to NNC0662-0419 s.c. once weekly. |
Inclusion Criteria: * Male or female (sex assigned at birth, inclusive of all gender identities). * Age 18 years or above at the time of signing the informed consent. * Body mass index (BMI) greater than or equal to (≥) 30.0 kilogram per square meter (kg/m\^2) at screening. * Participant must have ...
NNC0662-0419 is an investigational small molecule medicine being developed by Novo Nordisk for metabolic conditions. It is being studied in type 2 diabetes, obesity, and overweight. It has not been approved by any regulatory authority and remains in clinical development.
NNC0662-0419 is being studied for the treatment of type 2 diabetes, obesity, and overweight. Clinical trials are evaluating whether different doses lower blood sugar in people with type 2 diabetes and help people living with overweight or obesity. It is investigational and not approved for any use.
NNC0662-0419 is developed by Novo Nordisk A/S, which trades on the New York Stock Exchange under the ticker NVO. Novo Nordisk is the sponsor of the clinical trials studying the compound in type 2 diabetes, obesity, and overweight.
NNC0662-0419 is in Phase 2 clinical development. Two Phase 2 trials are active, one recruiting in type 2 diabetes and one active but not recruiting in obesity, alongside a completed Phase 1 study. It is investigational and has not received FDA approval.
Four trials have studied NNC0662-0419. NCT07415954 is a recruiting Phase 2 trial of different doses in type 2 diabetes. NCT07639021 and NCT07184632 are Phase 2 trials in obesity or overweight that are active but not recruiting. NCT07525791 is a Phase 1 study in women with excess body weight.
Across the four clinical trials of NNC0662-0419, total planned enrollment is 465 participants. The trials are randomized, double blind, and placebo controlled. Enrollment includes 270 participants in the type 2 diabetes Phase 2 trial and 233 in the obesity dose-increase Phase 2 trial.