Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Cagrilintide
NNC0174-0833 · 37 trials · 11 indications
Measured as percentage (%).
Measured in percentage (%).
Measured in percentage points.
Measured as count of participant.
Measured in percentage (%).
Measured in percentage-points.
Measured in percentage (%)
Measured as count of participants
Measured in days.
Count of participant.
Measured in percentage (%)
Measured as count of participants
Measured in ratio to baseline.
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.
Measured as percentage of participants.
Measured as hour\*nanomole per liter (h\*nmol/L).
Measured as nanomole per liter (nmol/L).
Measured in hour nanomoles per litre (h\*nmol/L)
Measured in nanomoles per litre (nmol/L).
Measured in percentage (%).
Measured in micromoles per 100 grams per minute (μmol/100g/min).
Measured in percentage (%).
Measured in hours\*nanomoles per liter (hours\*nmol/L).
Measured in hours\*nmol/L.
Measured in percentage (%).
Measured in millimeter. VAS appetite questions record the participants' sensations within Hunger, Satiety, Fullness and Prospective food consumption by the participants on a paper printed scale line from 0 to 100 mm. The appetite score will be calculated as \[hunger + (100 - satiety) + (100 - fullness) + prospective food consumption\]/4. Scores of 0 mm are worst and scores of 100 mm are best.
Measured in millisecond
measured in h·nmol/L
measured in nmol⸱h/L
measured in nmol/L
measured in nmol⸱h/L
measured in nmol/L
nmol\*h/L
h\*pg/mL
h\*pg/mL
Measured in h\*nmol/L
Count of events
| Arm | Type | Description |
|---|---|---|
| Cagrilintide + placebo semaglutide in device 1 and placebo cagrilintide in device 2 | EXPERIMENTAL | Participants will receive cagrilintide along with placebo matched to semaglutide in device 1 and placebo matched to cagrilintide in device 2 subcutaneously (s.c) once weekly for 26 weeks. |
| Cagrilintide in device 2 and placebo cagrilintide + placebo semaglutide in device 1 | EXPERIMENTAL | Participants will receive cagrilintide in device 2 and placebo matched to cagrilintide along with placebo matched to semaglutide in device 1 s.c once weekly for 26 weeks. |
| Placebo cagrilintide in device 2 and placebo cagrilintide + placebo semaglutide in device 1 | PLACEBO_COMPARATOR | Participants will receive placebo matched to cagrilintide in device 2 and placebo matched to cagrilintide along with placebo matched to semaglutide in device 1 s.c once weekly for 26 weeks. |
| CagriSema | EXPERIMENTAL | Participants will receive once weekly subcutaneous (s.c.) dose of CagriSema (cagrilintide and semaglutide) in a dose escalation regimen in the main phase for up to 16 weeks and maintained for 52 weeks and further continue to receive the same dose or maximum tolerated dose (MTD) in the open-label extension phase for up to 156 weeks. |
| Semaglutide | EXPERIMENTAL | Participants will receive once weekly s.c. dose of semaglutide in a dose escalation regimen in the main phase for up to 16 weeks and maintained for 52 weeks. |
| Cagrilintide | EXPERIMENTAL | Participants will receive once weekly s.c. dose of cagrilintide in a dose escalation regimen in the main phase for up to 16 weeks and maintained for 52 weeks, further continue to receive the same dose as the dose escalation regimen or MTD in the open-label extension phase for up to 156 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive once weekly s.c. dose of placebo matched to cagrilintide/semaglutide in a dose escalation regimen in the main phase for up to 16 weeks and maintained for 52 weeks. Participants will further continue to receive the same dose escalation regimen as CagriSema for 16 weeks, later continue to receive the same dose or MTD in the open-label extension phase for up to 140 weeks. |
| Tirzepatide | EXPERIMENTAL | Participants will receive once-weekly s.c injections of tirzepatide at escalating dose in a 4-week dose escalating period and maintained up to 56 weeks. |
| CagriSema Dose 1 | EXPERIMENTAL | Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 8-week dose escalation period until target dose (dose 1) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 60 weeks. |
| Placebo Dose 1 | PLACEBO_COMPARATOR | Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 1 (cagrilintide and semaglutide) for 68 weeks. |
| CagriSema Dose 2 | ACTIVE_COMPARATOR | Participants will receive once-weekly s.c injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 12-week dose escalation period until target dose (dose 2) of CagriSema(cagrilintide and semaglutide) is achieved and maintained up to 56 weeks. |
| Placebo Dose 2 | PLACEBO_COMPARATOR | Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 2 (cagrilintide and semaglutide) for 68 weeks. |
| CagriSema 2.4 mg/2.4 mg | EXPERIMENTAL | Participants will receive 2.4 mg cagrilintide and 2.4 mg semaglutide subcutaneously once-weekly (dose escalation period of 16 weeks) for up to 84 weeks. |
| Tirzepatide 15 mg | ACTIVE_COMPARATOR | Participants will receive 15 mg tirzepatide subcutaneously once-weekly (dose escalation period of 20 weeks) for up to 84 weeks. |
| Semaglutide Dose 1 | ACTIVE_COMPARATOR | Participants will receive once-weekly s.c injection of semaglutide dose 1 for 68 weeks. |
| Semaglutide Dose 2 | ACTIVE_COMPARATOR | Participants will receive once-weekly s.c injection of semaglutide dose 2 for 68 weeks. |
| Cagrilintide Dose 1 | ACTIVE_COMPARATOR | Participants will receive once-weekly s.c injection of cagrilintide dose 1 for 68 weeks. |
| Semaglutide 2.4 mg | ACTIVE_COMPARATOR | Participants will receive semaglutide s.c. 2.4 mg and placebo matched to semaglutide OW after a dose escalation period of 16 weeks (0.25 mg for weeks 0-4, 0.5 mg for weeks 5-8, 1 mg for weeks 9-12 and 1.7 mg for weeks 13-16) during the maintenance period for 52 weeks |
| Placebo s.c. | PLACEBO_COMPARATOR | Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide once weekly for 68 weeks. Participants randomised to this arm will be included in the extension phase for 97 weeks. |
| 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. |
| Cagrilintide B | EXPERIMENTAL | Participants will receive cagrilintide B subcutaneously once weekly for 5 weeks. |
| Cagrilintide D | EXPERIMENTAL | Participants will receive cagrilintide D subcutaneously once weekly for 5 weeks. |
| Cagrilintide B and Placebo Semaglutide I | EXPERIMENTAL | Participants will receive Cagrilintide B and Placebo semaglutide I subcutaneously once weekly for up to 17 weeks. |
| Cagrilintide D-Injection site 1 | EXPERIMENTAL | Participants will receive Cagrilintide D subcutaneously once weekly for up to 17 weeks. |
| Cagrilintide D-Injection site 2 | EXPERIMENTAL | Participants will receive Cagrilintide D subcutaneously once weekly for up to 17 weeks. |
| Cagrilintide D-Injection site 3 | EXPERIMENTAL | Participants will receive Cagrilintide D subcutaneously once weekly for up to 17 weeks. |
| Placebo Cagrilintide | PLACEBO_COMPARATOR | Participant will receive placebo matched to Cagrilintide subcutaneously once weekly for up to 17 weeks. |
| CagriSema +Atorvastatin + Warfarin | EXPERIMENTAL | Participants will receive a single dose of atorvastatin and a single dose of warfarin followed by a 16-week CagriSema dose escalation period and a 7-week CagriSema maintenance period. Participants will also receive a single dose of atorvastatin and a single dose of warfarin in the maintenance period. |
| Part A | OTHER | Participants will not get any medicine during this study. |
| Part B | EXPERIMENTAL | Participants will receive CagriSema or placebo (Dose 1,2,3,4) for 16-weeks dose-escalation period followed by 37-weeks intervention period on CagriSema or placebo (Dose 5) that includes a 12-day standardised energy intake period. |
| Cagrilintide (Arm 1) | EXPERIMENTAL | Participants will receive 0.6 milligrams (mg) of cagrilintide subcutaneously once weekly and the dose will be then escalated once in 2 weeks for 8 weeks until the target maintenance dose of 4.5 mg is reached followed by a 38-day post-treatment period. In addition, a single dose of moxifloxacin placebo prior to initiation of treatment and a single dose moxifloxacin placebo at the end of the treatment period will be administered orally. |
| Cagrilintide Placebo (Arm 2A) | ACTIVE_COMPARATOR | Participants will receive cagrilintide placebo subcutaenously once weekly. In addition, a single dose of moxifloxacin active prior to initiation of treatment and a single dose of moxifloxacin placebo at the end of the treatment period will be administered orally. |
| Cagrilintide Placebo (Arm 2B) | ACTIVE_COMPARATOR | Participants will receive cagrilintide placebo subcutaneously once weekly. In addition, a single dose of moxifloxacin placebo prior to initiation of treatment and a single dose of moxifloxacin active at the end of the treatment period will be administered orally. |
| NNC0174 0833 1.8 mg | EXPERIMENTAL | Each participant will receive one single dose of NNC0174 0833 |
| NNC0174 0833 0.9 mg | EXPERIMENTAL | Each participant will receive one single dose of NNC0174 0833 |
| NNC0174 0833 0.3 mg | EXPERIMENTAL | Each participant will receive one single dose of NNC0174 0833 |
| Part A: Cagrilintide and semaglutide in separate syringes | EXPERIMENTAL | Participants will up-titrated for 14 weeks (dose escalation every 4 weeks and 2 weeks at last dose escalation step prior to randomisation) with cagrilintide and semaglutide administered as separate injections. Followed by 8 weeks treatment with cagrilintide and semaglutide administered as separate injections. The 8-week treatment period covers 2 different doses of cagrilintide and semaglutide (1.7/1.7 mg and 2.4/2.4 mg with 4 weeks on each dose combination). Followed by a 38 days follow-up period. |
| Part A: Cagrilintide and semaglutide combined in DV3384 device | EXPERIMENTAL | Participants will be up-titrated for 14 weeks (dose escalation every 4 weeks and 2 weeks at last dose escalation step prior to randomisation) with cagrilintide and semaglutide administered as separate injections. Followed by 8 weeks of treatment with cagrilintide and semaglutide administered using the DV3384 manual syringe. The 8-week treatment period covers 2 different doses of cagrilintide and semaglutide (1.7/1.7 mg and 2.4/2.4 mg with 4 weeks on each dose combination. Followed by a 38 days follow-up period. |
| Part B: Cagrilintide and semaglutide combined in DV3384 device | EXPERIMENTAL | Participants will receive a single injection of Cagrilintide 0.25 mg/semaglutide 0.25 mg using the DV3384 manual syringe followed by a 28 days follow-up period. |
| 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 | - |
| NNC0174-0833 10 mg/mL | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Cagrilintide | DRUG | Cagrilintide will be administered subcutaneously. |
| Placebo cagrilintide | DRUG | Placebo matched to cagrilintide will be administered subcutaneously. |
| Placebo semaglutide | DRUG | Placebo matched to semaglutide will be administered subcutaneously. |
| Semaglutide | DRUG | Participants will receive semaglutide subcutaneously. |
| Placebo | DRUG | Placebo matched to cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling. |
| Placebo (matched to Cagrilintide) | DRUG | Placebo matched to cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling. |
| Tirzepatide | DRUG | Participants will receive once-weekly tirzepatide subcutaneously. |
| 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. |
| Cagrilintide B | DRUG | Cagrilintide B will be administered subcutaneously. |
| Cagrilintide D | DRUG | Cagrilintide D will be administered subcutaneously. |
| Cagrilintide B and placebo semaglutide I | DRUG | Cagrilintide B and placebo semaglutide I will be administered subcutaneously |
| Atorvastatin | DRUG | Atorvastatin will be administered as a single dose orally 2 times during the study. |
| Warfarin | DRUG | Warfarin will be administered as a single dose orally 2 times during the study. |
| No treatment given | OTHER | Participants will not get any medicine during this study. |
| Cagrilintide and Semaglutide | DRUG | Participants will receive subcutaneous (s.c.) injections of Cagrilintide and Semaglutide. |
| Cagrilintide Placebo | DRUG | Participants will receive cagrilintide placebo subcutaneously once weekly. |
| Moxifloxacin | DRUG | Partcipants will receive a single dose of moxifloxacin orally. |
| Moxifloxacin Placebo | DRUG | Partcipants will receive a single dose of moxifloxacin orally. |
| NNC0174 0833 | DRUG | Participants will either get a single dose of 0.3 mg, 0.9 mg or 1.8 mg NNC0174-0833, administered subcutaneously (s.c., under the skin) |
| 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: * 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. * Male or female (sex assigned at birth, inclusive of all gender i...
NNC0174-0833 is an investigational small molecule developed by Novo Nordisk A/S for overweight and obesity. It is a Phase 1 clinical development candidate in the metabolic therapeutic area. It has been studied in trials enrolling participants with overweight or obesity, including a Phase 2 study that completed with 706 participants.
NNC0174-0833 is being developed for the treatment of overweight and obesity. It has been studied in clinical trials involving participants with overweight or obesity, including a Phase 2 trial and several Phase 1 trials. It is not approved for any indication and remains investigational.
NNC0174-0833 is developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk is the sponsor of the clinical trials evaluating this small molecule for overweight and obesity.
NNC0174-0833 is in Phase 1 clinical development. It has completed three Phase 1 trials and one Phase 2 trial. The Phase 2 trial, NCT03856047, enrolled 706 participants with overweight or obesity. No active trials are currently listed for this candidate.
NNC0174-0833 has been evaluated in four completed trials: NCT05254158 in Chinese volunteers, NCT04209049 in people with normal and impaired kidney function, NCT04074174 studying interaction with a birth control pill, and NCT03856047, a Phase 2 trial in overweight or obesity. All trials are completed.
Yes, NNC0174-0833 is also known as NNC0174 0833, NNC0174 0833 10 mg/mL, and NNC0174 0833/mL. These are alternative names for the same investigational small molecule developed by Novo Nordisk A/S for overweight and obesity.