Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Semaglutide J · 2 trials · 2 indications
Change in HbA1c from baseline (week 0) to end of treatment (week 28) is presented. The endpoint was evaluated based on the data from in-study period. The in-study period is defined as the uninterrupted time interval from date of randomisation to date of least contact with trial site.
Measured in hours\*nanomoles per liter (h\*nmol/L).
| Arm | Type | Description |
|---|---|---|
| Semaglutide J | EXPERIMENTAL | Participants will initially receive 0.25 milligrams (mg) subcutaneous injections of semaglutide J once weekly (OW) and the dose will be then escalated once in 4 weeks for 8 weeks until the target maintenance dose of 1.0 mg is reached which will be maintained for a period of 20 weeks. Metformin will be considered as background therapy during the trial. |
| Semaglutide B | ACTIVE_COMPARATOR | Participants will initially receive 0.25 mg subcutaneous injections of semaglutide B OW and the dose will be then escalated once in 4 weeks for 8 weeks until the target maintenance dose of 1.0 mg is reached which will be maintained for a period of 20 weeks. Metformin will be considered as background therapy during the trial. |
| Sequence A: Semaglutide J-Semaglutide C-Semaglutide J | EXPERIMENTAL | After 6 weeks of run-in dose escalation period participants will orally receive semaglutide J at dose level 1 once daily for 4 weeks followed by semaglutide C once daily for next 4 weeks and thereafter semaglutide J at dose level 3 once daily for next 4 weeks. |
| Sequence B: Semaglutide C-Semaglutide J-Semaglutide J | EXPERIMENTAL | After 6 weeks of run-in dose escalation period participants will orally receive semaglutide C once daily for 4 weeks followed by semaglutide J at dose level 2 once daily for next 4 weeks and thereafter semaglutide J at dose level 4 once daily for next 4 weeks. |
| Sequence C: Semglutide J-Semaglutide J-Semaglutide C | EXPERIMENTAL | After 6 weeks of run-in dose escalation period participants will orally receive semaglutide J at dose level 1 once daily for 4 weeks followed by semaglutide J at dose level 3 once daily for next 4 weeks and thereafter semaglutide C (2x dose) once daily for next 4 weeks. |
| Sequence D: Semaglutide J-Semaglutide C-Semaglutide J | EXPERIMENTAL | After 6 weeks of run-in dose escalation period participants will orally receive semaglutide J at dose level 2 once daily for 4 weeks followed by semaglutide C (2x dose) once daily for next 4 weeks and thereafter semaglutide J at dose level 4 once daily for next 4 weeks. |
| Name | Type | Description |
|---|---|---|
| Semaglutide J | DRUG | Participants will initially receive 0.25 mg subcutaneous injections of semaglutide J OW and the dose will be then escalated once in 4 weeks for 8 weeks until the target maintenance dose of 1.0 mg is reached which will be maintained for a period of 20 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 28). |
| Semaglutide B | DRUG | Participants will initially receive 0.25 mg subcutaneous injections of semaglutide B OW and the dose will be then escalated once in 4 weeks for 8 weeks until the target maintenance dose of 1.0 mg is reached which will be maintained for a period of 20 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 28). |
| Semaglutide C | DRUG | Participants will receive oral semglutide C in treatment sequence A and B; and at semglutide C at 2x dose level in treatment sequence C and D. |
Inclusion Criteria: * Diagnosed with type 2 diabetes (T2D) mellitus greater than equal to (≥) 180 days before screening. * Stable daily dose(s) ≥ 90 days prior to the day of screening of metformin ≥ 1500 milligrams (mg) or maximum tolerated or effective dose. * HbA1c of 7.0-10.5 percentage (%) \[53...
Semaglutide J is an investigational small molecule being developed by Novo Nordisk for the treatment of Type 2 Diabetes Mellitus. It is currently in Phase 3 clinical development. A completed Phase 3 trial compared two semaglutide medicines in people with Type 2 Diabetes, with 388 participants enrolled.
Semaglutide J is a small molecule developed by Novo Nordisk. Its molecular target has not been disclosed in available information. The drug is being studied for its effects in Type 2 Diabetes and in healthy participants to assess blood levels of oral semaglutide.
Semaglutide J is 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 for Type 2 Diabetes and in healthy participants.
Semaglutide J is in Phase 3 clinical development for Type 2 Diabetes Mellitus. It has received FDA accelerated approval designation. The drug is investigational and not yet approved for commercial use. A Phase 3 trial has been completed, and a Phase 1 trial in healthy participants has also been completed.
Semaglutide J has been studied in two completed trials. NCT05478252 is a Phase 3 study comparing two semaglutide medicines in Type 2 Diabetes, enrolling 388 participants across the US, Canada, Poland, Slovakia, and South Africa. NCT05784402 is a Phase 1 study in healthy participants measuring blood levels of oral semaglutide, enrolling 264 participants in the US and Canada.
Semaglutide J appears to be related to oral semaglutide, as a Phase 1 trial studied how much semaglutide is found in the blood with different tablets of oral semaglutide in healthy participants. However, the exact relationship between Semaglutide J and oral semaglutide is not fully detailed in available information.