CDSCO Panel Approves Novo Nordisk Protocol Amendment Proposal For CagriSema
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Novo-Nordisk protocol amendment proposal for the clinical trial titled “The cardiovascular safety and efficacy of cagrilintide 2.4 mg s.c. in combination with semaglutide 2.4 mg s.c. (CagriSema 2.4 mg/2.4 mg s.c.) once-weekly in participants with obesity and established cardiovascular disease”.
This came after Novo-Nordisk presented protocol amendment, version 6.0 dated 14 September 2023, protocol No. NN9838-4942.
CagriSema is a once-weekly injection of semaglutide and cagrilintide. Phase 2 clinical trial results for CagriSema showed significant improvements in A1C, weight loss, and time in range, marking it as a promising new type 2 diabetes treatment.
Cagrilintide is an amylin-analogue, now being developed in combination with the GLP-1 agonist semaglutide to achieve sustained weight loss in persons with overweight and obesity.
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