Lilly Launches Second Phase 3 Clinical Trial of Oral GLP-1R Agonist Orforglipron for Type 2 Diabetes

On August 2, Eli Lilly registered a Phase III ACHIEVE-1 study (NCT05971940) on Clinicaltrials.gov, evaluating the efficacy and safety of the oral small molecule GLP-1R agonist Orforglipron in adult patients with type 2 diabetes whose blood glucose is inadequately controlled by exercise and diet alone. This is the second Phase III study conducted by Eli Lilly to assess the efficacy and safety of Orforglipron in type 2 diabetes patients, following the ACHIEVE-4 study.

The ACHIEVE-1 study plans to enroll 520 adult patients with type 2 diabetes (HbA1c: 7.0%~9.5%) who have a body mass index (BMI) ≥23kg/m².

Orforglipron is a novel, highly effective, orally administered non-peptide GLP-1R agonist. In 2018, Eli Lilly and Company collaborated with Chugai, paying an upfront fee of 50 million US dollars to acquire global development and commercialization rights for Orforglipron, which was in the preclinical stage at that time.

Currently, Eli Lilly has launched several Phase III clinical trials of Orforglipron to further investigate its efficacy and safety in treating obesity and overweight (ATTAIN series studies) as well as type 2 diabetes (ACHIEVE series studies).

On April 7 this year, Eli Lilly registered and initiated the ACHIEVE-4 study (NCT05803421), the world's first Phase III clinical trial of Orforglipron, aiming to compare the efficacy and safety of insulin glargine versus Orforglipron in patients with type 2 diabetes who are obese or overweight and at increased cardiovascular risk. The target enrollment is 2,620 patients.

At the same time, Eli Lilly and Company successively initiated three ATTAIN series studies in May this year, namely, the ATTAIN-1 study (NCT05869903), the ATTAIN-2 study (NCT05872620), and the ATTAIN-J study (NCT05931380).

The ATTAIN-1 study is a global Phase III trial designed to evaluate the efficacy and safety of once-daily oral Orforglipron in adult patients with obesity or overweight who have obesity-related comorbidities, with a target enrollment of 3,000 patients.

The ATTAIN-2 study is a global Phase III trial designed to evaluate the efficacy and safety of once-daily oral Orforglipron in obese or overweight adult patients with type 2 diabetes. The study plans to enroll 1,500 adult patients with type 2 diabetes (HbA1c: 7%-10%) and a BMI ≥27 kg/m² who have experienced at least one failed dietary weight loss attempt.

The ATTAIN-J study is a Phase III study conducted in Japan aimed at evaluating the efficacy and safety of once-daily oral Orforglipron in adult obese patients with obesity-related complications.

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