CDSCO Panel Approves Eli Lilly's Protocol Amendment Proposal for Retatrutide study
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the protocol amendment proposal presented by drug major Eli Lilly for Retatrutide study.
This came after the firm presented a protocol amendment dated 19 September 2024 protocol no. J1I-MC-GZBO. This is a phase 3, randomized, double-blind, placebo-controlled, event-driven study to investigate the effect of retatrutide on the incidence of major adverse cardiovascular events and the decline in kidney function in participants with body mass index ≥27 kg/m2 and atherosclerotic cardiovascular disease and/or chronic kidney disease.
Retatrutide (LY3437943) is an agonist of the glucose-dependent insulinotropic polypeptide, glucagon-like peptide 1, and glucagon receptors. Its dose-response relationships with respect to side effects, safety, and efficacy for the treatment of obesity are not known. Retatrutide activates the GIP, GLP-1, and glucagon receptors that are involved with controlling hunger and satiety, allowing people to feel fuller after eating for longer. This helps to regulate blood sugar levels, leading to weight loss.
At the recent SEC meeting with cardiovascular held on 8th January 2025, the expert panel reviewed the protocol amendment dated 19 September 2024 protocol no. J1I-MC-GZBO.
After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.
