Eli Lilly gets CDSCO Panel Nod To study antidiabetic drug Orforglipron
New Delhi: The drug major Eli Lilly has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the Phase III clinical trial of the antidiabetic drug LY3502970 (Orforglipron), a novel, oral non-peptide glucagon-like peptide-1 receptor agonist.
This came after the firm presented a Phase III clinical trial protocol no. J2A-MC-GZGQ, before the committee.
The proposed study is a Phase 3, randomized, double-blind study to investigate the efficacy and safety of once-daily oral LY3502970 compared with placebo in adult participants with obesity or overweight and type 2 diabetes.
This study will investigate the safety and efficacy of once-daily oral treatment with orforglipron compared with placebo on body weight in adult participants with obesity or overweight and type 2 diabetes. The study will last about 77 weeks and may include up to 22 visits.
LY3502970 is a potent, selective, orally active non-peptide agonist of glucagon-like peptide-1 (GLP-1) receptor. LY3502970 is a partial agonist, biased toward G protein activation over β-arrestin recruitment at the GLP-1R.
Orforglipron is a once-daily oral nonpeptide GLP-1 receptor agonist in development for weight management and type 2 diabetes, and its oral formulation could improve access and adherence challenges. It works by binding to GLP-1 receptors and stimulating insulin release from the pancreas when it is needed. It also slows down how fast food travels through your digestive tract.
At the recent SEC meeting for endocrinology and metabolism held on 27th and 29th September 2023, the expert panel reviewed the Phase III clinical trial protocol of LY3502970 presented by drug major Eli Lilly.
After detailed deliberation, the committee recommended a grant of permission to conduct the clinical trial.
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