Written By: Pharmacally Medical News Desk
Innovent Biologics has reported positive results from its Phase 1b clinical trial of Mazdutide, a dual glucagon-like peptide-1 (GLP-1) and glucagon receptor agonist, in Chinese adolescents with obesity. The trial met its primary endpoint and showed meaningful reductions in body mass index (BMI), body weight, and several metabolic risk markers after 12 weeks of treatment.
This randomized, double-blind, placebo-controlled study enrolled 36 adolescents between 12 and 18 years old who met national criteria for obesity and had previously failed to achieve significant weight loss with diet and exercise. Participants were assigned to receive either Mazdutide at 4 mg or 6 mg or a placebo, with weekly subcutaneous injections over the 12-week treatment period.
At the end of the study, both dosage groups of Mazdutide showed statistically significant improvements versus placebo. The 4 mg cohort achieved an average BMI reduction of 8.78% from baseline, while the 6 mg group saw a 10.99% reduction. Corresponding mean body weight losses were 7.72 kg and 8.65 kg, respectively. By contrast, the placebo group’s BMI and weight reduction were modest at 1.73% and 1.42 kg.
Beyond weight loss, Mazdutide treatment was associated with improvements in a range of metabolic parameters. Trends toward favorable changes were seen in waist circumference, blood pressure, blood lipid profiles, serum uric acid, liver transaminases, and glycemic control measures. These signals suggest broader metabolic benefits alongside weight reduction in adolescents with obesity.
Safety data from the study were encouraging. All participants completed the planned visits, and there were no serious adverse events reported in the Mazdutide groups. No one discontinued treatment due to adverse events. The most commonly reported side effects were mild to moderate gastrointestinal symptoms, consistent with expectations for GLP-1-based therapies. Pharmacokinetic profiles of Mazdutide in adolescents were comparable to those previously observed in adults.
Obesity rates among children and adolescents have increased sharply worldwide over the past decades, and China reflects this trend with rapidly rising prevalence. Despite the scale of the problem and associated risks such as hypertension, dyslipidemia, type 2 diabetes, and psychosocial impacts, there are currently no approved medications specifically for weight loss in children or adolescents in China. The need for effective and safe treatment options in this age group is significant.
Mazdutide has also been evaluated in the Phase 3 DREAMS-3 trial (NCT06184568), a randomized, open-label study comparing once-weekly Mazdutide 6 mg with semaglutide 1 mg in adults with type 2 diabetes and obesity inadequately controlled on metformin, providing later-stage confirmation of its metabolic efficacy.
Encouraged by the Phase 1b results, Innovent plans to initiate a larger Phase 3 registrational trial in adolescent participants with obesity or overweight soon. If further studies confirm these findings, Mazdutide could become one of the first pharmacologic options in China for adolescents struggling with obesity and its metabolic consequences.
Note: These findings are based on the company’s press release and news reports. Clinical data should be interpreted in the context of a peer-reviewed publication once available.
References
Mazdutide Demonstrates Significant Weight Loss and Metabolic Benefits in Phase 1b Clinical Trial in Chinese Adolescents with Obesity, 12 December 2025, https://en.innoventbio.com/InvestorsAndMedia/PressReleaseDetail?key=571
Innovent and Lilly’s Mazdutide Outperforms Semaglutide in Phase 3 DREAMS-3 Trial with Superior Glycemic Control and Weight Loss, 28 October 2025, https://pharmacally.com/innovent-and-lillys-mazdutide-outperforms-semaglutide-in-phase-3-dreams-3-trial-with-superior-glycemic-control-and-weight-loss/