Eli Lilly Gets CDSCO Panel Nod to Study Retatrutide
New Delhi: Pharmaceutical major Eli Lilly has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct a Phase III clinical study of Retatrutide.
However, this nod is subject to the condition that the principal investigator (PI) should be a cardiologist and Co-Principal Investigator (Co-PI) should be a nephrologist.
This came after Eli Lilly presented Phase III clinical study protocol No. J1I-MC-GZBO dated 05.01.2024.
The main purpose of this study is to determine if retatrutide can significantly lower the incidence of serious heart-related complications or prevent the worsening of kidney function. This trial will enroll adults with body mass index 27 kg/m^2 or higher and Atherosclerotic Cardiovascular Disease and/or chronic kidney disease. The study will last for about 5 years.
Retatrutide is an experimental drug for obesity developed by American pharmaceutical company Eli Lilly and Company. It is a triple hormone receptor agonist of GLP-1, GIP, and GCGR receptors
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 for cardiovascular held on July 9, 2024, the expert panel reviewed the Phase III clinical study protocol No. J1I-MC-GZBO dated 05.01.2024, presented by Eli Lilly.
After detailed deliberation, the committee recommended the grant of permission to conduct the trial with the condition that the principal investigator (PI) should be a cardiologist and Co-Principal Investigator (Co-PI) should be a nephrologist.
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