CDSCO Panel Approves Eli Lilly's Protocol Amendment Proposal for Retatrutide study
Written By : Dr. Divya Colin
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-01-19 12:30 GMT | Update On 2025-01-19 12:30 GMT
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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.
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