CDSCO Panel Approves Novo Nordisk's Protocol Amendment Proposal for CagriSema Study

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Novo Nordisk's proposal for the protocol amendment of the antidiabetic drug combination Cagrilintide and Semaglutide (CagriSema) study.

This came after the firm presented protocol amendment version 2.0 dated 05 October 2023 protocol No.: NN9388-4896.This is a research study to see how well CagriSema compared to Semaglutide, Cagrilintide and Placebo lowers blood sugar and body weight in people with type 2 diabetes treated with Metformin with or without an SGLT2 Inhibitor.

CagriSema is a new weekly medicine that combines two medicines called Semaglutide and Cagrilintide.

The study will look at how well CagriSema helps people lower their blood sugar and body weight. CagriSema is a new weekly medicine that combines two medicines called semaglutide and cagrilintide. CagriSema will be compared to the two medicines semaglutide and cagrilintide, when they are taken alone. CagriSema will also be compared to a "dummy" medicine without any active ingredient. The study will be done in participants who have type 2 diabetes. Participants will take the study medicine together with the current diabetes medicine (metformin with or without an SGLT2 inhibitor).

Cagrilintide/semaglutide, marketed as CagriSema, is a combination of cagrilintide, a dual amylin and calcitonin receptor agonist, and semaglutide, a GLP-1 agonist. It is injected once weekly and is being tested for type 2 diabetes and obesity.

CagriSema is a combination medication that includes semaglutide and a drug called Cagrilintide. This means that it mimics the action of amylin, a hormone produced by the pancreas that makes people feel "satiety," or “fullness,” after eating a meal.

At the recent SEC meeting for Endocrinology and Metabolism held on 7th March 2024, the expert panel reviewed the protocol amendment version 2.0 dated 05 October 2023 protocol No.: NN9388-4896.

After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.

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