Novo Nordisk Gets CDSCO Panel Nod to Study Cagrilintide plus semaglutide
New Delhi:The drug major Novo Nordisk has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct a phase II clinical study of the antidiabetic drug combination cagrilintide plus semaglutide.
However, this approval is subject to the condition that the firm should include the nephrologists as principal investigators (PI) or co-principal investigators (Co-PI) from the same site or institute.
This came after Novo Nordisk presented Phase II clinical study protocol No. NN9388-7700, version 1.0, dated 25 September 2023.
Cagrilintide/semaglutide is a combination of cagrilintide, a dual amylin and calcitonin receptor agonist, and semaglutide, a GLP-1 agonist. It is injected once a week and is being tested for type 2 diabetes and obesity.
Cagrilintide is a long-acting amylin analog under investigation for weight management. Semaglutide, a GLP-1 receptor agonist, reduces appetite via GLP-1 receptors in the hypothalamus, increases the production of insulin, and reduces glucagon secretion, delaying gastric emptying.
At the recent SEC meeting for endocrinology and metabolism held on June 19, 2024, the expert panel reviewed the Phase II clinical study protocol No. NN9388-7700 version No. 1.0 dated 25 September 2023, presented by the drug major Novo Nordisk.
After detailed deliberation, the committee recommended the grant of permission to conduct the trial with the condition that the firm should include the nephrologists as principal investigators (PI) or co-principal investigators (Co-PI) from the same site or institute.
