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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03856047 | Research Study Investigating How Well NNC0174-0833 Works in People Suffering From Overweight or Obesity. | PHASE2 | COMPLETED | 706 | — | — | Mar 1, 2019 | Mar 25, 2021 | Jul 5, 2024 | 54 | United States, Canada +8 |
| NCT04209049 | A Research Study Looking Into Blood Levels of NNC0174-0833 in People With Normal and Impaired Kidney Function | PHASE1 | COMPLETED | 33 | — | — | Jan 15, 2020 | Jan 5, 2021 | Jan 26, 2021 | 2 | United States |
| NCT04074174 | Research Study to Investigate the Effect of NNC0174-0833 on a Birth Control Pill in Women Who Are Not Able to Become Pregnant | PHASE1 | COMPLETED | 31 | — | — | Sep 12, 2019 | Mar 6, 2020 | Jan 10, 2022 | 1 | Canada |
Change in body weight (%) from week 0 to week 26 is presented. For descriptive analysis and statistical analysis the endpoint was evaluated based on the data from in-trial period and treatment adherent period, respectively. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. Treatment-adherent: a participant is treatment adherent until the first time of non-adherence defined as: participant has not been dosed with trial product within the prior 14 days; participant has received other weight management drug or bariatric surgery; participant has not reached target dose at a pre-specified week; After the pre-specified evaluation week for the target dose, the participant has not received the target dose ±10% within the prior 14 days.
nmol\*h/L
h\*pg/mL
h\*pg/mL
| Arm | Type | Description |
|---|---|---|
| NNC0174-0833, 4.5 mg | EXPERIMENTAL | Patients will receive 4.5 mg of NNC0174-0833 once a week as injections for 26 weeks. |
| NNC0174-0833, 2.4 mg | EXPERIMENTAL | Patients will receive 2.4 mg of NNC0174-0833 once a week as injections for 26 weeks. |
| NNC0174-0833, 1.2 mg | EXPERIMENTAL | Patients will receive 1.2 mg of NNC0174-0833 once a week as injections for 26 weeks. |
| NNC0174-0833, 0.6 mg | EXPERIMENTAL | Patients will receive 0.6 mg of NNC0174-0833 once a week as injections for 26 weeks. |
| NNC0174-0833 0.3 mg | EXPERIMENTAL | Patients will receive 0.3 mg of NNC0174-0833 once a week as injections for 26 weeks. |
| Placebo 2.4 mg (NNC0174-0833) | PLACEBO_COMPARATOR | Patients will receive 2.4 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks. |
| Placebo 4.5 mg (NNC0174-0833) | PLACEBO_COMPARATOR | Patients will receive 4.5 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks. |
| Placebo 1.2 mg (NNC0174-0833) | PLACEBO_COMPARATOR | Patients will receive 1.2 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks. |
| Placebo 0.6 mg (NNC0174-0833) | PLACEBO_COMPARATOR | Patients will receive 0.6 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks. |
| Placebo 0.3 mg (NNC0174-0833) | PLACEBO_COMPARATOR | Patients will receive 0.3 mg of NNC0174-0833 once a week as injections for 26 weeks. |
| Liraglutide 3.0 mg | ACTIVE_COMPARATOR | Patients will receive 3.0 mg of liraglutide once daily as injections for 26 weeks. |
| Placebo 3.0 mg (Liraglutide) | PLACEBO_COMPARATOR | Patients will receive placebo 3.0 mg(liraglutide) once daily as injections for 26 weeks. |
| Normal renal function | EXPERIMENTAL | All subjects will receive one dose of NNC0174-0833. |
| Mild renal impairment | EXPERIMENTAL | All subjects will receive one dose of NNC0174-0833. |
| Moderate renal impairment | EXPERIMENTAL | All subjects will receive one dose of NNC0174-0833. |
| Severe renal impairment | EXPERIMENTAL | All subjects will receive one dose of NNC0174-0833. |
| NNC0174-0833 treatment-free period; NNC0174-0833 treatment | EXPERIMENTAL | During the NNC0174-0833 treatment-free period participants will receive OC tablets and acetaminophen. During the NNC0174-0833 treatment period participants will receive OC tablets and acetaminophen in addition to NNC0174-0833. |
| Name | Type | Description |
|---|---|---|
| NNC0174-0833 | DRUG | Participants will get one dose of NNC0174-0833 once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks. |
| Placebo (NNC0174-0833) | DRUG | Participants will get one dose of Placebo (NNC0174-0833) once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks. |
| Liraglutide 3.0 mg | DRUG | Participants will get one dose of liraglutide 3.0 mg once daily. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using pre-filled PDS290 pen-injector. Participants will gradually increase their dose every week until they reach the target dose of 3.0 mg daily. The participants will continue on 3.0 mg of liraglutide, once daily up to 26 weeks. |
| Placebo (Liraglutide 3.0 mg) | DRUG | Participants will get one dose of Placebo (liraglutide 3.0 mg) once daily. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using pre-filled PDS290 pen-injector. Participants will gradually increase their dose every week until they reach the target dose of 3.0 mg. The participants will continue on Placebo (liraglutide 3.0 mg), once daily up to 26 weeks. |
| Oral contraceptive (OC) tablets | DRUG | 1 tablet daily on days 1-8 and days 79-86 |
| Acetaminophen | DRUG | Single dose of acetaminophen as part of a standardised meal on day 1 and day 79 |
Inclusion Criteria: * 18 years or older at the time of signing the informed consent. * Female subject of non-childbearing potential or Male subject who is surgically sterilised (vasectomy) or who is willing to use adequate contraceptive methods (as required by local regulation or practice) througho...