In a Phase 2 study, mazdutide — a new GLP-1 and GCG receptor agonist — helped participants lose weight, improve cardiometabolic factors such as blood pressure and cholesterol levels, and lower liver fat content.
With the undisputed popularity of diabetes/weight loss drugs like Ozempic, Wegovy, and others, pharmaceutical companies continue to look for other, perhaps better options. Now, one new option developed by a Chinese pharmaceutical firm looks promising, as it may do more than help a person lose weight.
On October 29, Innovent Biologics, Inc. announced the results of a 48-week Phase 2 clinical study examining the safety and effectiveness of mazdutide at a higher dose (9 mg) in Chinese participants with obesity.
Mazdutide, or OXM3, is a GLP-1 and GCGR receptor dual agonist developed by Innovent through a licensing agreement with Eli Lilly and Company. In addition to the effects of its GLP-1 receptor agonists on boosting insulin secretion, lowering blood sugar, and body weight reduction, mazdutide may also increase energy expenditure and improve liver fat metabolism by activating glucagon receptors.
Overall, the trial showed that 24 weeks after the start of treatment, participants with obesity taking mazdutide lost an average of 32 pounds. At week 48, participants shed 39 pounds on average.
Moreover, as participants lost weight, their average waist circumference and blood pressure levels decreased.
After week 24, those taking the new weight loss drug also saw significant reductions in triglyceride, total cholesterol, low-density lipoprotein cholesterol, and serum uric acid levels. These changes remained stable during the treatment extension to 48 weeks.
In addition, among participants with a baseline liver fat content above 5%, treatment with mazdutide reduced fat in the liver by 73.3% after 24 weeks.
"Mazdutide 9 mg induced a placebo-adjusted 18.6% weight loss after 48 weeks of treatment. The weight loss effect is even comparable to that of metabolic surgery and is also the highest placebo-adjusted weight loss among the current GLP-1 drugs in Chinese subjects after 48 weeks of treatment," said Dr. Lei Qian, the Vice President of Clinical Development at Innovent.
"Mazdutide 9 mg also provided additional benefits, such as reduced waist circumference, blood pressure, blood lipids, liver fat content, ALT, and serum uric acid in subjects with obesity," Qian adds.
Mazdutide's side effects appeared minimal, as no participants discontinued treatment, and no serious adverse events occurred throughout the 48-week trial.
Common side effects were mild to moderate nausea, vomiting, and diarrhea. However, these effects lessened as treatment continued.
Overall, mazdutide's safety profile through 48 weeks of treatment was consistent with previous studies and other GLP-1-based drugs.
Innovent expects to begin a Phase 3 study of mazdutide 9 mg for obesity by the end of 2023.
If the novel weight loss drug shows positive outcomes and safety profiles in the Phase 3 trial, the next step is FDA approval. If that happens, mazdutide will likely be the next hot new weight loss drug to enter the arena since the approval of popular semaglutide-based drugs like Ozempic and Wegovy.
- Innovent. Innovent Announces Robust Weight Loss Efficacy, Multiple Metabolic Benefits and Favorable Safety Profile of Higher Dose 9 mg Mazdutide (IBI362) after 48-week Treatment in Phase 2 Study for Obesity.
- ClinicalTrials.gov. A Study of IBI362 Evaluating Weight Loss in Obese and Overweight Chinese Subjects.