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Semaglutide J · 1 trial · 1 indication
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.
| 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. |
| 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). |
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 GLP-1 receptor agonist developed by Novo Nordisk A/S for the treatment of type 2 diabetes mellitus. It is in Phase 3 clinical development and has been studied in a completed active-controlled trial. It is not described as approved.
Semaglutide J is being developed for the treatment of type 2 diabetes mellitus. Its clinical program has focused on comparing it with another semaglutide medicine in adults with type 2 diabetes. The studied population was adults 18 years and older, with no healthy volunteers enrolled.
Semaglutide J targets GLP1R, the glucagon-like peptide-1 receptor, and acts as a receptor agonist. GLP-1 receptor agonists are a recognized drug class in metabolic medicine. The completed Phase 3 study evaluated this small molecule in people with type 2 diabetes.
Semaglutide J is developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk is the sponsor of the clinical program for this asset in type 2 diabetes mellitus.
Semaglutide J is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently listed as active. The program has enrolled 388 participants in total, and the drug is investigational rather than approved.
Semaglutide J has been studied in NCT05478252, titled A Research Study to Compare Two Semaglutide Medicines in People With Type 2 Diabetes. This completed Phase 3 trial enrolled 388 participants across the United States, Canada, Poland, Slovakia, and South Africa. It was randomized, double-blind, and active-controlled.