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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05016882 | Research Study on Whether a Combination of 2 Medicines (NNC0194 0499 and Semaglutide) Works in People With Non-alcoholic Steatohepatitis (NASH) | PHASE2 | COMPLETED | 698 | — | — | Aug 31, 2021 | Mar 14, 2025 | Nov 19, 2025 | 255 | United States, Australia +22 |
| NCT05766709 | A Research Study Comparing Blood Levels of Medicines NNC0194-0499 and Semaglutide Administered as a Combination Formulation Versus Two Separate Formulations | PHASE1 | COMPLETED | 53 | — | — | Mar 2, 2023 | Feb 9, 2024 | Feb 29, 2024 | 1 | Canada |
| NCT04722653 | A Research Study Looking at How the Medicine NNC0194-0499 Behaves in Japanese and Non-Asian Men | PHASE1 | COMPLETED | 42 | — | — | Feb 2, 2021 | Apr 27, 2021 | Apr 5, 2022 | 1 | Japan |
Count of subjects Improvement in fibrosis is defined as greater than or equal to 1 grade improvement on the NASH CRN fibrosis scale
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
Count of events
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| 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 |
| NNC0194-0499 | DRUG | NNC0194-0499 will be administered subcutaneously once weekly. |
| Semaglutide | DRUG | Semaglutide will be administered subcutaneously once weekly. |
| 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. |
| Placebo (NNC0194-0499 ) | DRUG | 1 single dose administered subcutaneously (s.c. - under the skin). |
Inclusion Criteria: * Aged greater than or equal to 18 years at the time of signing informed consent. In Republic of Korea, subjects must be aged greater than or equal to 19 years. In Japan, subjects must be aged greater than or equal to 20 years. In Singapore, subjects must be aged greater than or...