CDSCO Panel Approves Eli Lilly's Protocol Amendment Proposal for Antidiabetic Drug Retatrutide study
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Eli Lilly's protocol amendment proposal for the antidiabetic Drug Retatrutide (LY3437943) study.
This came after the firm presented protocol amendment(d) dated 27 August 2024 and protocol addendum 2 dated 01 October 2024 protocol no. J1I-MC-GZBJ. This is a study of Retatrutide (LY3437943) in participants who have obesity or are overweight.
The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants who have obesity or overweight (J1I-MC-GZBJ master protocol), including subsets of participants who have knee osteoarthritis (OA) (J1I-MC-GOA1) or who have obstructive sleep apnea (OSA) (J1I-MC-GSA1).
Retatrutide (LY3437943) is an investigational agent that combines agonism with three key hormones that influence eating and metabolism into a single molecule. It is an agonist of the glucose-dependent insulinotropic polypeptide, glucagon-like peptide 1, and glucagon receptors.
At the recent SEC meeting for endocrinology and metabolism held on 11th December 2024, the expert panel reviewed the protocol amendment (d) dated 27 August 2024 and protocol addendum 2 dated 01 October 2024 protocol no. J1I-MC-GZBJ.
After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.
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