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.
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