Eli Lilly Submits IND Application in China for Oral GLP-1R Agonist LY3502970 for Type 2 Diabetes and Obesity

On March 22, the CDE website showed that the clinical trial application for Eli Lilly's LY3502970 capsule had been accepted by the pharmaceutical regulatory agency. This marks the first time the product has been submitted for clinical trials in China.

LY3502970 Capsule is a novel, highly effective, oral non-peptide GLP-1R agonist, initially developed by Chugai. In September 2018, Eli Lilly and Company reached an agreement with Chugai to obtain global development and commercialization rights for LY3502970. Currently, Eli Lilly and Company is conducting Phase II studies of LY3502970 for type 2 diabetes and obesity.

In October 2022, Eli Lilly and Company announced positive results from the Phase I clinical study, showing that the once-daily LY3502970 treatment group demonstrated safety comparable to GLP-1R agonist injectable formulations, potent glucose-lowering efficacy, and significant weight loss effects.

Phase I clinical study consisted of 5 cohorts, with inclusion criteria as follows: patients aged 18-70 years, diagnosed with type 2 diabetes for ≥6 months, HbA1c ≥7.0% and ≤10.5%. These patients were randomly assigned in a 3:1 ratio to receive once-daily different doses of LY3502970 (n=51) or placebo (n=17) for 12 weeks. Baseline characteristics were generally balanced across the groups.

On Day 84 of treatment, the maximum plasma concentration (Cmax) in patients receiving different doses of LY3502970 ranged from 60 ng/mL to 236 ng/mL, with a median time to reach peak concentration (tmax) of 4 to 8 hours. Additionally, patients experienced reductions in HbA1c ranging from 1.5% to 1.8% (compared to a 0.4% reduction in the placebo group) and weight loss between 1.6 kg and 5 kg (compared to a 0.5 kg weight gain in the placebo group).

In terms of safety, the most commonly reported treatment-emergent adverse events in the LY3502970 group were nausea (47.1%), decreased appetite (45.1%), and vomiting (43.1%). These occurred early in the treatment and decreased over time. One patient reported two severe gastrointestinal events (one instance each of nausea and vomiting); all other events were mild or moderate. No clinically relevant liver abnormalities or serious adverse events related to LY3502970 were reported.

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