Lilly Launches First Phase 3 Trial of Oral GLP-1R Agonist Orforglipron for Weight Management

On May 22, Eli Lilly registered a Phase III clinical trial (A TTAIN-1) on the ClinicalTrials.gov website, aiming to evaluate the efficacy and safety of once-daily oral Orforglipron (LY3502970) for treating adult patients with obesity or overweight accompanied by weight-related comorbidities.

The ATTAIN-1 study plans to enroll 3,000 participants with a body mass index (BMI) ≥30 kg/m² or ≥27 kg/m² who have been previously diagnosed with at least one of the following weight-related comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, etc. These individuals must have experienced at least one failed attempt at dietary weight loss.

The primary endpoint of the study was the change in participants' weight from baseline at week 72; secondary endpoints included the mean percentage change from baseline at week 72 in waist circumference, systolic blood pressure, fasting non-high-density lipoprotein cholesterol, fasting triglycerides, glycated hemoglobin (HbA1c), fasting blood glucose, fasting insulin, diastolic blood pressure, and Health Survey Short Form (SF-36v2) scores.

LY3502970 is a novel, potent, orally available non-peptide GLP-1R agonist. In 2018, Eli Lilly and Company partnered with Chugai, paying an upfront fee of $50 million to acquire global development and commercialization rights for LY3502970, which was then in the preclinical stage.

Previously published Phase I clinical trial results (n=133) showed that in the LY3502970 group, HbA1c decreased by 1.5%-1.8% (compared to a 0.4% decrease in the placebo group), and weight decreased by 1.6-5 kg (the placebo group experienced a 0.5 kg weight increase). The most common adverse events were nausea (47.1%), decreased appetite (45.1%), and vomiting (43.1%), which lessened over time with continued treatment.

Partial Phase I Study Data of LY3502970 (Source: Eli Lilly and Company Official Website)

Globally, Eli Lilly is the leading player in the fastest-progressing oral small-molecule GLP-1R agonist track. Among its developments, the Phase II study of LY3502970 for type 2 diabetes and obesity has been completed, and a Phase III clinical trial comparing it with insulin glargine (personalized dose, once daily) for obese or overweight patients with type 2 diabetes at increased cardiovascular risk was initiated in April this year.

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