Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NNC0194-0499 · 11 trials · 10 indications
Measured as logarithm score
Count of subjects Improvement in fibrosis is defined as greater than or equal to 1 grade improvement on the NASH CRN fibrosis scale
Percentage point (%-points).
%-points.
h-pg/mL
h-pg/mL
Measured in nanomoles hour per liter (nmol h/L).
Measured as nanomoles\*hours per liter (nmol\*h/L)
Measured as nmol\*h/L
Measured as nanomoles per liter (nmol/L)
Measured as nmol/L
Measured in nanomoles\*hours per liter (nmol h/L).
Measured as hours\*nanomoles per litre (h\*nmol/L)
Count of events
| Arm | Type | Description |
|---|---|---|
| NNC0194-0499 + semaglutide | EXPERIMENTAL | Group A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 in combination with semaglutide. |
| NNC0194-0499 + semaglutide placebo | EXPERIMENTAL | Group A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 in combination with semaglutide placebo. |
| NNC0194-0499 placebo + semaglutide | EXPERIMENTAL | Group A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 placebo in combination with semaglutide. |
| NNC0194-0499 placebo + semaglutide placebo | PLACEBO_COMPARATOR | Group A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 placebo in combination with semaglutide placebo. |
| CagriSema | EXPERIMENTAL | Group B: Participants will receive subcutaneous (s.c.) injection of cagrilintide in combination with semaglutide. |
| Cagrilintide + semaglutide placebo | EXPERIMENTAL | Group B: Participants will receive subcutaneous (s.c.) injection of cagrilintide in combination with semaglutide placebo. |
| Cagrilintide placebo + semaglutide placebo | PLACEBO_COMPARATOR | Group B: Participants will receive subcutaneous (s.c.) injection of cagrilintide placebo in combination with semaglutide placebo. |
| NNC0194-0499 7.5 mg + semaglutide 2.4 mg | EXPERIMENTAL | Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections. |
| Placebo (NNC0194-0499) 7.5 mg + semaglutide placebo 2.4 mg | PLACEBO_COMPARATOR | Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections. |
| NNC0194-0499 15 mg + semaglutide 2.4 mg | EXPERIMENTAL | Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections. |
| Placebo (NNC0194-0499) 15 mg + semaglutide placebo 2.4 mg | PLACEBO_COMPARATOR | Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections. |
| NNC0194-0499 30 mg + semaglutide 2.4 mg | EXPERIMENTAL | Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections. |
| NNC0194-0499 30 mg + semaglutide placebo 2.4 mg | EXPERIMENTAL | Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections. |
| Placebo (NNC0194-0499) 30 mg + semaglutide 2.4 mg | ACTIVE_COMPARATOR | Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections. |
| Placebo (NNC0194-0499) 30 mg + semaglutide placebo 2.4 mg | PLACEBO_COMPARATOR | Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections. |
| NNC0174-0833 2.4 mg + semaglutide 2.4 mg | EXPERIMENTAL | Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections. |
| Placebo (NNC0174-0833) 2.4 mg + semaglutide placebo 2.4 mg | PLACEBO_COMPARATOR | Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections. |
| Part A: NNC0194-0499/Placebo | EXPERIMENTAL | After a 2-week run-in period; participants will be randomised 1:1 to a treatment sequence with two 7-week treatment periods of once weekly subcutaneous NNC0194-0499 or placebo. Between the two treatment periods; there is a wash-out period. After the wash-out period, there will be a cross over, ensuring that all the participants receive both NNC0194-0499 and placebo. |
| Part B: NNC0194-0499/Placebo + Semaglutide | EXPERIMENTAL | After the 2-week run-in phase followed by the 8-week of dose escalation period (every 4 weeks) of once weekly subcutaneous semaglutide; participants will be randomised 1:1 to a treatment sequence with two 7-week treatment periods of once weekly subcutaneous NNC0194-0499 or placebo and continued semaglutide. Between the two treatment periods; there is a wash-out period where the participant continues to receive once weekly subcutaneous semaglutide. After the wash-out period, there will be a cross over, ensuring that all the participants receive both NNC0194-0499 and placebo together with semaglutide. |
| Sequence 1 | EXPERIMENTAL | All participants will be exposed to both interventions in a defined sequence. OC 8 days, NNC0194-0499 4 weeks, OC/NNC0194-0499 combined 1 week. |
| Participants With Normal Hepatic Function | EXPERIMENTAL | Participants with normal hepatic function will receive a single subcutaneous dose of 30 milligram (mg) of NNC0194-0499 on Day 1. |
| Participants With Mild Hepatic Impairment | EXPERIMENTAL | Participants with mild hepatic impairment (Child Pugh Grade A) will receive a single subcutaneous dose of 30 mg of NNC0194-0499 on Day 1. |
| Participants With Moderate Hepatic Impairment | EXPERIMENTAL | Participants with moderate hepatic impairment (Child-Pugh Grade B) will receive a single subcutaneous dose of 30 mg of NNC0194-0499 on Day 1. |
| Participants With Severe Hepatic Impairment | EXPERIMENTAL | Participants with severe hepatic impairment (Child-Pugh Grade C) will receive a single subcutaneous dose of 30 mg of NNC0194-0499 on Day 1. |
| Group 1 | EXPERIMENTAL | Participants will receive separate injections of NNC0194-0499 B and Semaglutide B for 24 weeks. Dose escalation manner every 4 weeks for 20 weeks (30 mg NNC0194-0499 B and 0.24 mg Semaglutide B for Weeks 1-4, 30 mg NNC0194-0499 B and 0.5 mg Semaglutide B for Weeks 5-8, 30 mg NNC0194-0499 B and 1.0 mg Semaglutide B for Weeks 9-12, 30 mg NNC0194-0499 B and 1.7 mg Semaglutide B for Weeks 13-16 and 30 mg NNC0194-0499 B and 2.4 mg Semaglutide B for Weeks 17-20). Participants will receive NNC0194-0499/Semaglutide A 40/3.20 mg/mL co-formulation at the target dose of 30/2.4 mg during the weeks 21-24 (maintenance dosing period). |
| Group 2 | EXPERIMENTAL | Participants will receive NNC0194-0499/Semaglutide A 40/3.20 mg/mL co-formulation for 24 weeks. Dose escalation manner every 4 weeks for 20 weeks (3.1mg/0.25mg for Weeks 1-4, 6.3mg/0.5mg for Weeks 5-8, 12.5mg/1.0mg for Weeks 9-12, 21.3mg/1.7mg for Weeks 13-16 and 30mg/2.4mg for weeks 17-20). Participants will receive NNC0194-0499/Semaglutide 40/3.20 mg/mL co-formulation at the target dose of 30mg/2.4mg during the weeks 21-24 (maintenance dosing period). |
| Group 3 | EXPERIMENTAL | Participants will receive 4 weekly injections of NNC0194-0499/Semaglutide A 40/0.33 mg/mL co-formulation at the dose level of 30mg/0.25 mg. |
| NNC0194-0499 12 mg | EXPERIMENTAL | Participants will receive a single subcutaneous (s.c.) dose of 12 milligrams (mg) NNC0194-0499 on Day 1. |
| NNC0194-0499 30 mg | EXPERIMENTAL | Participants will receive a single s.c. dose of 30 mg NNC0194-0499 on Day 1. |
| NNC0194-0499 96 mg | EXPERIMENTAL | Participants will receive a single s.c. dose of 96 mg NNC0194-0499 on Day 1. |
| Participants with normal renal function | ACTIVE_COMPARATOR | Participants will receive a single subcutaneous injection of 30 mg NNC0194-0499. |
| Participants with impaired renal function | EXPERIMENTAL | Participants will receive a single subcutaneous injection of 30 mg NNC0194-0499. |
| NN0194-0499 | EXPERIMENTAL | Japanese participants will be randomised 3:1 to receive either a single dose of NNC0194-0499 or placebo, Asian participants will only receive NNC0194-0499. There will be 3 cohorts with escalating dose levels. There should be at least 4 days between dose administration of the last participant in a dose level cohort and dose administration of the first participant in the following dose level cohort. |
| Placebo | PLACEBO_COMPARATOR | Japanese participants will be randomised 3:1 to receive either a single dose of NNC0194-0499 or placebo. |
| NNC0194-0499 | EXPERIMENTAL | Participants will receive increasing doses of NNC0194-0499. The treatment period from first treatment (Day 1) to end of the treatment (Day 85) will be 12 weeks. |
| Name | Type | Description |
|---|---|---|
| NNC0194-0499 | DRUG | Administered subcutaneously. |
| Semaglutide | DRUG | Administered subcutaneously. |
| NNC0194-0499 placebo | DRUG | Administered subcutaneously. |
| Semaglutide placebo (Group A) | DRUG | Administered subcutaneously. |
| Cagrilintide + semaglutide | DRUG | Administered subcutaneously. |
| Cagrilintide | DRUG | Administered subcutaneously. |
| Cagrilintide placebo | DRUG | Administered subcutaneously. |
| Semaglutide placebo (Group B) | DRUG | Administered subcutaneously. |
| NNC0194 0499 50 mg/mL | DRUG | Patients will receive subcutaneous (s.c., under the skin) injections of NNC0194-0499 once weekly The study will last for about 19 months |
| Placebo (NNC0194-0499) | DRUG | Patients will receive subcutaneous (s.c., under the skin) injections of placebo once weekly The study will last for about 19 months |
| Semaglutide 3 mg/mL | DRUG | Patients will receive subcutaneous (s.c., under the skin) injections of semaglutide once weekly The study will last for about 19 months |
| Semaglutide placebo | DRUG | Patients will receive subcutaneous (s.c., under the skin) injections of semaglutide placebo once weekly The study will last for about 19 months |
| NNC0174 0833 10 mg/mL | DRUG | Patients will receive subcutaneous (s.c., under the skin) injections of NNC0174-0833 once weekly The study will last for about 19 months |
| NNC0174 0833 placebo | DRUG | Patients will receive subcutaneous (s.c., under the skin) injections of NNC0174-0833 placebo once weekly The study will last for about 19 months |
| Placebo | DRUG | Participants will receive placebo matched to NNC0194-0499 subcutaneously. |
| ethinylestradiol/levonorgestrel | DRUG | Oral contraceptive is taken as tablet daily composed of 30 μg ethinylestradiol and 150 μg levonorgestrel. |
| NNC0194-0499/Semaglutide A (40/3.20 mg/mL) | DRUG | NNC0194-0499/Semaglutide A (40/3.20 mg/mL) co-formulation product will be administered subcutaneously once weekly. |
| NNC0194-0499/Semaglutide A (40/0.33mg/mL) | DRUG | NNC0194-0499/Semaglutide A (40/0.33mg/mL) will be administered subcutaneously once weekly. |
| NC0194-0499 | DRUG | Participants will receive a single s.c. dose of 96 mg NNC0194-0499 on Day 1. |
| Placebo (NNC0194-0499 ) | DRUG | 1 single dose administered subcutaneously (s.c. - under the skin). |
Inclusion Criteria: * Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. * Age 18 years or above, and at the legal drinking age according t...
NNC0194-0499 is an investigational small molecule being developed by Novo Nordisk for several conditions, including hepatic impairment, alcohol-related liver disease, non-alcoholic steatohepatitis (NASH), non-alcoholic fatty liver disease, and type 1 diabetes. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
NNC0194-0499 is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various liver and metabolic conditions.
NNC0194-0499 is currently in Phase 2 clinical development. The drug is investigational and has not been approved by the FDA or any other regulatory agency. It has completed several Phase 1 trials and is being studied for conditions such as NASH and type 1 diabetes.
NNC0194-0499 has been studied in several clinical trials, including NCT05727644, which examined blood and urine levels in participants with reduced kidney function, and NCT05742919, which looked at how a single dose behaves in Chinese men. NCT06188026 studied its interaction with birth control pills, and NCT07087795 is an active trial evaluating it alone or with semaglutide for type 1 diabetes.
Yes, NNC0194-0499 is being studied for type 1 diabetes. An active clinical trial, NCT07087795, is evaluating the effect of NNC0194-0499 alone or in combination with semaglutide on blood sugar control in people living with type 1 diabetes. This trial is currently in Phase 1 and is not yet recruiting participants.