Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NNC0174-0833 · 7 trials · 3 indications
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
Measured in h\*nmol/L
Count of events
| 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. |
| NNC0174-0833 (0.3 mg) | EXPERIMENTAL | Participants will receive single dose of NNC0174-0833 |
| NNC0174-0833 (0.9 mg) | EXPERIMENTAL | Participants will receive single dose of NNC0174-0833 |
| NNC0174-0833 (1.8 mg) | EXPERIMENTAL | Participants will receive single dose of NNC0174-0833 |
| Placebo (NNC0174-0833) | PLACEBO_COMPARATOR | Participants will receive placebo (NNC0174-0833) |
| NNC0174-0833+Semaglutide | EXPERIMENTAL | Participants will receive increasing doses of NNC0174-0833 along with semaglutide. The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks. |
| Placebo (NNC0174-0833)+Semaglutide | ACTIVE_COMPARATOR | Participants will receive placebo (NNC0174-0833) along with semaglutide. The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks |
| NNC0174-0833 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| NNC0174-0833 10 mg/mL | EXPERIMENTAL | - |
| 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 |
| Semaglutide | DRUG | Participants will receive 2.4 mg of semaglutide (s.c., in a lifted fold of the abdominal skin) injection once weekly starting with a very low dose and then escalated every 4 weeks to a slightly higher dose each time. |
| Placebo | DRUG | Dosed either once daily or once weekly |
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...
NNC0174-0833 is an investigational small molecule being developed for the treatment of overweight and obesity, as well as related metabolism and nutrition disorders. It is intended for use in people who are overweight or obese, and clinical studies have included participants with these conditions.
NNC0174-0833 is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker symbol NVO. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for weight management.
NNC0174-0833 is in clinical development, with trials completed in Phase 1 and Phase 2. The most advanced study was a Phase 2 trial, which has been completed. The drug is not yet approved and remains investigational, requiring further studies to establish its safety and effectiveness.
NNC0174-0833 has been studied in several completed clinical trials, including NCT02300844, a Phase 1 single-dose study in healthy males; NCT03856047, a Phase 2 efficacy study in overweight or obese individuals; NCT04074174, a drug interaction study with oral contraceptives; and NCT04209049, a pharmacokinetic study in people with normal and impaired kidney function.
NNC0174-0833 is the drug name used in clinical trial registrations, with no alternative names provided in the available data. It is consistently referred to by this identifier across all studies, including those listed on ClinicalTrials.gov.