Submit Safety Data From Phase I CT : CDSCO Panel Tells Novo Nordisk on CagriSema
New Delhi: Reviewing the Phase II clinical study protocol of CagriSema, a combination medication that includes semaglutide and Cagrilintide, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major NovoNordisk to submit detailed safety data from Phase I study and to include the Nephrologists as principal investigator/ Co-Principal Investigator (PI /Co –PI) from the same site/institute where the study is planned.
This came after NovoNordisk presented Phase II clinical study protocol No. NN9388-7700.
CagriSema is a combination medication that includes semaglutide and a drug called Cagrilintide. It mimics the action of amylin, a hormone produced by the pancreas that makes people feel “satiety,” or “fullness,” after eating a meal.
Cagrilintide is an amylin-analog, now being developed in combination with the GLP-1 agonist semaglutide to achieve sustained weight loss in persons with overweight and obesity.
Semaglutide belongs to a class of medications known as glucagon-like peptide-1 receptor agonists, or GLP-1 RAs. It mimics the GLP-1 hormone, released in the gut in response to eating. One role of GLP-1 is to prompt the body to produce more insulin, which reduces blood sugar (glucose).
At the recent SEC meeting for Endocrinology and Metabolism held on 24th January 2023, the expert panel reviewed the Phase II clinical study protocol for the FDC Cagrisema presented by the drug major Novo Nordisk.
After detailed deliberation, the committee recommended that the firm should submit detailed safety data from Phase I study for further review by the committee. Furthermore, the expert panel suggested that the firm should include the Nephrologists as PI /Co –PI from the same site/institute where the study is planned.
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