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.
Semaglutide injection is in a class of medications called incretin mimetics. It works by helping the pancreas to release the right amount of insulin when blood sugar levels are high. Insulin helps move sugar from the blood into other body tissues where it is used for energy.
At the recent SEC meeting for Endocrinology and Metabolism held on 14th December 2023, the expert panel reviewed the protocol amendment version 6.0 dated 14 September 2023, protocol No. NN9838-4942.
After detailed deliberation, the committee recommended approval of the protocol amendment and an increase in the number of subjects from 264 to 642 as presented by the firm.
