Innovent Biologics, Inc. announced that results of higher-dose cohorts in a phase 1b study of mazdutide (IBI362), a glucagon-like peptide-1 (GLP-1) and glucagon receptor dual agonist, in Chinese participants with overweight or obesity have been published online in eClinicalMedicine Professor Linong Ji and Professor Leili Gao from Peking University People's Hospital are joint first authors of the article. Professor Linong Ji and Dr. Lei Qian are the corresponding authors. This randomized, placebo-controlled multiple-ascending-dose study evaluated the safety, tolerability and pharmacokinetics/pharmacodynamics characteristics of mazdutide in Chinese participants with overweight or obesity (NCT04440345).

The results of lower-dose (3 mg, 4.5 mg and 6.0 mg) cohorts have been published in eClinicalMedicine in August 2021 . In higher-dose cohorts, 12 participants in each cohort were randomized 2:1 to receive subcutaneous 2.5- 5.0-7.5-10.0 mg (10 mg cohort) or 3.0-6.0-9.0 mg (9 mg cohort) mazdutide or placebo once weekly, with each dose level administered for 4 weeks. In higher-dose cohorts, mazdutide up-titrated to 10 mg and 9 mg were both well tolerated.

No participant discontinued the study due to adverse events. No serious adverse event or severe adverse event was reported. The most-commonly-reported treatment-emergent adverse events were gastrointestinal adverse events, mostly mild in severity.

At week 16, the mean reduction (percent reduction) from baseline in body weight was 7.62 kg (9.5%) for participants receiving mazdutide in the 10 mg cohort. At week 12, the mean reduction (percent reduction) from baseline in body weight was 9.23 kg (11.7%) for participants receiving mazdutide in the 9 mg cohort. Improvements in BMI, waist circumference, blood pressure, lipid and serum uric acid were similar with those observed in the low-dose cohorts.

Multiple clinical studies of mazdutide are ongoing, including 1) the higher-dose cohort of a Phase II study of mazdutide in Chinese adults with obesity, with first participant dosing completed in September 2022 and 2) a Phase III clinical study in Chinese adults with overweight or obesity initiated, which received IND approval in October 2022.