Innovent's Mazdutide Outperforms High-dose Dulaglutide in Phase 3 Trial for Chinese Type 2 Diabetes Patients

Innovent Biologics, Inc., a prominent biopharmaceutical company based in SAN FRANCISCO and SUZHOU, China, has announced the successful results of its Phase 3 clinical trial, DREAMS-2, evaluating the efficacy of mazdutide (IBI362) in Chinese patients with type 2 diabetes (T2D). The dual agonist, targeting both glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR), demonstrated superior glycemic control compared to dulaglutide, along with multiple cardiometabolic benefits.

The DREAMS-2 clinical trial, registered under ClinicalTrials.gov (NCT05606913), was a multi-center, randomized study designed to compare mazdutide and dulaglutide in T2D patients whose glycemic control was inadequate with metformin alone or with other oral drugs. The trial included 731 participants who were assigned to one of three groups: mazdutide 4.0 mg, mazdutide 6.0 mg, or dulaglutide 1.5 mg. The primary endpoint was the change in glycated hemoglobin (HbA1c) levels from baseline to week 28. The study initially aimed to establish non-inferiority between the treatments before assessing superiority.

Mazdutide successfully met the primary endpoint by showing significant glucose-lowering effects. Both dosages of mazdutide (4.0 mg and 6.0 mg) demonstrated non-inferiority to dulaglutide 1.5 mg and subsequently proved superior in further testing. Key secondary endpoints underscored mazdutide's benefits, including notable reductions in body weight and improvements in various cardiometabolic indicators such as blood pressure, blood lipids, serum uric acid, and liver enzymes.

The trial highlighted several significant outcomes for mazdutide. After 28 weeks of treatment, mazdutide exhibited superior reductions in HbA1c levels and body weight compared to dulaglutide. Moreover, a higher proportion of participants in the mazdutide groups achieved HbA1c levels below 7.0% and experienced substantial weight loss (≥ 5%). Mazdutide also showed advantages in reducing waist circumference, body mass index (BMI), systolic blood pressure (SBP), triglycerides (TG), serum uric acid (UA), and liver enzyme levels (ALT and AST).

Safety and tolerability were key aspects of the study. Gastrointestinal issues were the most common adverse events but were generally mild to moderate and transient, occurring mainly during the initial 12-week titration period. Importantly, no severe hypoglycemia incidents were reported, and the rates of moderate to severe hypoglycemia were similar to those seen with dulaglutide. There was no indication of increased cardiovascular risk, and the overall safety profile was consistent with previous mazdutide studies.

Mazdutide is the first GLP-1R/GCGR dual agonist under regulatory review, with a new drug application (NDA) for chronic weight management currently being evaluated by China’s National Medical Products Administration (NMPA). The DREAMS-2 study is a pivotal part of this review process and provides robust evidence for mazdutide's efficacy in the Chinese T2D population. Innovent plans to release results from another Phase 3 clinical trial, DREAMS-1, in mid-2024 and intends to submit an NDA for T2D treatment with mazdutide.

Leading endocrinologists, Professor Lixin Guo from Beijing Hospital and Professor Yang Wenying from China Japan Friendship Hospital, emphasized the significance of DREAMS-2. They highlighted the comprehensive benefits of mazdutide beyond glycemic control, including weight loss and improvements in blood lipids and pressure, which are critical for managing T2D and its associated comorbidities in China.

Innovent Biologics continues to advance in the biopharmaceutical industry, striving to provide innovative treatments for complex diseases. Founded in 2011, the company is committed to developing high-quality biologics that are accessible and affordable, with a portfolio that includes treatments for cancer, cardiovascular and metabolic diseases, autoimmune disorders, and ophthalmology.