CDSCO Panel Approves Eli Lilly's Protocol Amendment proposal to study Antidiabetic Drug Tirzepatide

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-08-04T17:45:47+05:30 | Updated On 4 Aug 2024 5:45 PM IST

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New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved the protocol amendment proposal presented by drug major Eli Lilly to study the antidiabetic drug Tirzepatide.

This came after drug maker Eli Lilly presented protocol amendment (b) dated 24 April 2024 protocol no. I8F-MC-GPIJ.

Tirzepatide is in a class of medications called glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonists.

Tirzepatide activation of GIP receptors augments insulin sensitivity and secretion and thereby helps reinforce the mechanisms regulating blood glucose levels.Tirzepatide activation of GIP receptors augments insulin sensitivity and secretion and thereby helps reinforce the mechanisms regulating blood glucose levels.

Dual GIP/GLP-1 agonists gained increasing attention as new therapeutic agents for glycemic and weight control as they demonstrated better glucose control and weight loss compared to selective GLP-1 receptor agonists in preclinical and clinical trials.

At the recent SEC meeting for Endocrinology and Metabolism held on July 11, 2024, the expert panel reviewed the proposal presented by the drug major Eli Lilly for the protocol amendment (b) dated 24 April 2024 protocol no. I8F- MC-GPIJ.

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

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Eli Lillycdscotirzepatideprotocol amendmentantidiabetic drug

Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751