Lilly's new obesity drug achieves phase 3 success in diabetes with Innovent

Innovent has achieved another significant milestone with mazdutide, demonstrating its efficacy over Eli Lilly's Trulicity in controlling blood sugar levels among patients with Type 2 diabetes. This latest success comes from the DREAMS-2 trial, which involved 731 patients in China who received either 4-mg or 6-mg doses of mazdutide or 1.5 mg of Trulicity.

Innovent acquired the rights to mazdutide from Eli Lilly in 2019. Earlier this year, Innovent announced that mazdutide had successfully completed a phase 3 weight loss study, marking it as the first GLP-1R/GCGR dual agonist to achieve such success in phase 3 trials. This promising trend continued with the DREAMS-2 trial.

After 28 weeks of treatment, both the 4-mg and 6-mg mazdutide groups exhibited superior improvement in glycated hemoglobin (HbA1c) levels when compared to the Trulicity group, meeting the primary endpoint of the trial. Additionally, key secondary endpoints also favored mazdutide. A greater proportion of patients in the mazdutide groups achieved more than 5% weight loss and HbA1c levels under 7%.

Most adverse events reported in the trial were gastrointestinal in nature, occurring primarily in the first 12-week titration period. These events were generally mild to moderate in severity, according to Innovent's postmarket release on May 8.

The data from DREAMS-2 will support the ongoing review of mazdutide for weight management by Chinese regulators. Another trial, DREAMS-1, is expected to provide results by mid-2024, after which Innovent plans to seek regulatory approval for mazdutide as a diabetes treatment in China.

Dr. Lei Qian, Vice President of Clinical Development at Innovent, stated that the DREAMS-2 study demonstrated mazdutide's comprehensive superiority over dulaglutide, one of the most commonly prescribed glucose-lowering drugs globally. He emphasized Innovent's commitment to further analyzing the study data and submitting an NDA for Type 2 diabetes as soon as possible to benefit more Chinese patients. Dr. Qian also expressed anticipation for mazdutide's performance in the upcoming DREAMS-3 trial, a direct comparison with semaglutide.

Eli Lilly retains the rights to develop mazdutide outside of China and continues to list the drug as a phase 2 candidate for obesity treatment.