CDSCO Panel Clears Eli Lilly's Tirzepatide for Phase IV Clinical Trial in India
New Delhi: The Subject Expert Committee (SEC), functioning under the Central Drugs Standard Control Organisation (CDSCO), has granted permission to Eli Lilly and Company (India) to conduct a Phase IV clinical trial for its Tirzepatide Solution for Injection in multiple-dose prefilled pens.
This came after the firm presented their proposal along with the Phase IV Clinical Trials Protocol for Tirzepatide 2.5 mg/0.6 ml, 5 mg/0.6 ml, 7.5 mg/0.6 ml, 10 mg/0.6 ml, 12.5 mg/0.6 ml and 15 mg/0.6 ml solution for injection in a multiple-dose prefilled pen before the Committee.
Tirzepatide is a novel dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist.
Glucagon-like peptide-1 (GLP-1) receptors (GLP-1R) are expressed throughout the body, including pancreatic beta-cells and the gastrointestinal tract. They have been implicated in the pathophysiology of type II diabetes mellitus, as GLP-1R signaling is involved in glucose control by enhancing glucose-stimulated insulin secretion, delaying gastric transit, decreasing plasma glucagon levels, and reducing body weight by activating anorexigenic pathways in the brain.
Both glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 are peptide hormones involved in glucose homeostasis: they promote glucose-stimulated insulin secretion from the pancreatic beta-cells. However, GIP is the main incretin hormone that exerts insulinotropic effects in response to food intake.
The exact mechanism of action of tirzepatide has not been fully elucidated; however, dual agonism at GIP and GLP-1R may contribute to the glycemic and weight control effects of the drug.
At the recent SEC meeting, the expert panel reviewed the proposal along with the Phase IV Clinical Trials Protocol for Tirzepatide 2.5 mg/0.6 ml, 5 mg/0.6 ml, 7.5 mg/0.6 ml, 10 mg/0.6 ml, 12.5 mg/0.6 ml and 15 mg/0.6 ml solution for injection in a multiple-dose prefilled pen.
After detailed deliberation, the Committee recommended the grant of permission to conduct the Phase IV Clinical Trials study as per the protocol presented before the Committee.
