ROCKVILLE, U.S. and SUZHOU, China, Dec 18, 2023，— Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, announces that results of a Phase 2 clinical trial of mazdutide (Innovent R&D code: IBI362), a glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, in Chinese patients with overweight or obesity were published in Nature Communications.

Professor Linong Ji, the leading principal investigator of the study, Peking University People’s Hospital, stated, "As a chronic disease with complex underlying causes, obesity is one of the leading risk factors of type 2 diabetes, fatty liver, cardiovascular and cerebrovascular diseases, joint diseases, sleep apnea in addition to cancers. Obesity requires increased public awareness of long-term treatment and management with effective and science-backed approaches. China has the largest obese population; however, no safe and efficacious pharmacotherapy is approved for obesity so far. I am very pleased to see the Phase 2 full results of the GLP-1R/GCGR dual agonist mazdutide in Chinese patients with overweight or obesity were accepted and published in Nature Communications. These data showed good safety and tolerability with mazdutide, which improves compliance of overweight and obese patients. Thereby, patients achieved rapid and robust weight loss efficacy and attained multiple cardiovascular and metabolic benefits, including reduced waist circumstance, blood pressure, blood lipids, transaminase as well as reduced serum uric acid. I look forward to more evidence from registrational phase 3 trial of mazdutide and hope it could bring a breakthrough treatment option to Chinese patients with overweight or obesity."

Dr. Lei Qian, Vice President of Clinical Development of Innovent, stated, "Mazdutide is the first-in-class Phase 3 stage GLP-1R/GCGR dual agonist for the treatment of both obesity and type 2 diabetes. The results of this Phase 2 study showed favorable safety, rapid and robust weight loss efficacy, multiple cardiovascular and metabolic benefits of mazdutide in Chinese patients with overweight or obesity, underscoring its differentiated advantages over GLP-1 single target agents. Currently, the phase 3 study of mazdutide 4 mg and 6 mg in Chinese patients with overweight or obesity (GLORY-1) are underway, which will provide critical clinical evidence in large sample size. We recently also initiated the Phase 3 study to provide higher dose mazdutide 9mg for population with higher baseline of obesity. We hope that this high-quality medicine will benefit the Chinese patients as soon as possible, and provide personalized treatment plans for different degrees of obesity."

The published results were from the first part of a randomized, double-blind, placebo-controlled Phase 2 trial (ClinicalTrials.gov, NCT04904913, part 1 evaluated mazdutide 3mg, 4.5mg and 6mg, part 2 evaluated mazdutide 9mg). A total of 248 overweight adults (body-mass index [BMI] ≥24 kg/m2) accompanied by hyperphagia and/or at least one obesity-related comorbidity or adults with obesity (BMI ≥28 kg/m2) were randomly assigned to receive 3 mg mazdutide, 4.5 mg mazdutide, 6 mg mazdutide or placebo subcutaneously for 24 weeks. The primary outcome was percentage change from in body weight from baseline to week 24. Mean baseline body weight was 89.4 kg and mean baseline BMI was 31.8 kg/m2 in enrolled patients.

The results showed that mazdutide significantly reduced body weight in all doses.

The mean percent change from baseline to week 24 in body weight were −6.7%, −10.4%, and −11.3% with mazdutide 3 mg, 4.5 mg and 6 mg, respectively and −1.0% with placebo; and the placebo-adjusted mean percent change from baseline to week 24 in body weight were −7.7%, −11.4%, and −12.3% with mazdutide 3 mg, 4.5 mg and 6 mg, respectively.
The proportion of patients with body weight loss of ≥5% at week 24 were 58.1%, 82.5% and 80.3% with mazdutide 3 mg, 4.5 mg and 6 mg, respectively (4.8% with placebo);
The proportion of patients with body weight loss of ≥10% at week 24 were 19.4%, 49.2% and 50.8% with mazdutide 3 mg, 4.5 mg and 6 mg, respectively (0 with placebo).

The results showed that mazdutide was safe and well-tolerated.

No study drug-related serious adverse events or adverse events leading to treatment discontinuation occurred.
The overall safety profile of mazdutide was similar to those observed in early phase development of mazdutide and with other GLP-1R agonist drugs.
The most frequently reported treatment-emergent adverse events included nausea, diarrhea and vomiting, most of them reported as mild or moderate and occurred during the dose titration period.
The heart rate increase observed during the treatment of mazdutide were similar to other GLP-1R agonist drugs. No signal of increased cardiovascular risk was observed.

Furthermore, mazdutide also reduced multiple cardiovascular and metabolic factors including waist circumference, blood pressure, lipids, serum uric acid, transaminase etc. Full results can be found in Nature Communications.

https://www.innoventbio.com/InvestorsAndMedia/PressReleaseDetail?key=422