Innovent’s Mazdutide Cuts BMI by Up to 11% in Adolescents with Obesity, Advances to Phase 3 Trial

Innovent Biologics reported positive Phase 1b data for mazdutide (IBI362) in Chinese adolescents with obesity, showing statistically significant reductions in BMI and body weight, multiple metabolic improvements, and a favorable safety profile after 12 weeks of treatment.

The findings were presented as an oral presentation at the 2026 American Diabetes Association (ADA) Scientific Sessions and support advancement into the registrational Phase 3 GLORY-YOUNG trial (NCT07255209)

First Approved Dual GCG/GLP-1 Receptor Agonist

Mazdutide is the first approved dual glucagon (GCG) and glucagon-like peptide-1 (GLP-1) receptor agonist. By activating both pathways, the therapy promotes weight loss, improves glucose metabolism, and may provide broader metabolic benefits than GLP-1 receptor agonists alone. Innovent has already secured approval in China for adults with obesity and type 2 diabetes.

Despite rising obesity rates among Chinese adolescents, no pharmacological treatment has yet been approved for this population in China, highlighting a significant unmet medical need.

Study Design and Safety Profile

The randomized, double-blind, placebo-controlled Phase 1b study enrolled 36 adolescents aged 12 to under 18 years with obesity who had failed to achieve meaningful weight reduction despite at least 12 weeks of diet and exercise intervention. Participants received once weekly mazdutide 4 mg, mazdutide 6 mg, or placebo for 12 weeks. The primary objective was to evaluate safety and tolerability.

Both dose levels demonstrated a favorable safety profile. All participants completed the study and all protocol-required visits. No serious adverse events, severe treatment-emergent adverse events, or treatment discontinuations occurred during treatment.

The most common adverse events included decreased appetite, vomiting, diarrhea, and nausea, which were generally mild to moderate and occurred during dose escalation. Pharmacokinetic analyses showed exposure levels consistent with those previously observed in adults.

Clinically Meaningful Efficacy

Mazdutide produced substantial reductions in body weight and BMI. Mean BMI declined by 8.78% in the 4 mg group and 10.99% in the 6 mg group, compared with 1.73% for placebo. Body weight decreased by 7.87% (7.72 kg) and 9.93% (8.65 kg) in the 4 mg and 6 mg groups, respectively, versus 1.19% (1.42 kg) with placebo.

All comparisons versus placebo achieved nominal statistical significance (P<0.01). Investigators also reported improvements in waist circumference, blood pressure, lipid parameters, and glucose metabolism markers, suggesting benefits that extend beyond weight reduction alone.

Adolescent Obesity Program Outlook

Lei Qian, PhD, Chief R&D Officer of General Biomedicine at Innovent, said the findings confirm that mazdutide’s weight-loss and metabolic benefits observed in adults can also be reproduced in adolescents with obesity. He noted that the results provide a strong scientific foundation for further clinical development while addressing a major unmet need in China.

Innovent is conducting multiple Phase 3 studies of mazdutide across obesity, type 2 diabetes, metabolic dysfunction-associated fatty liver disease (MAFLD), obstructive sleep apnea, hypertension, and other cardiometabolic conditions. The ongoing GLORY-YOUNG study will further evaluate mazdutide’s potential to become the first approved pharmacological treatment for adolescent obesity in China.

Reference

Innovent Announces Phase 1b Clinical Study Results of Mazdutide in Chinese Adolescents with Obesity Presented as an Oral Report at the American Diabetes Association (ADA) Scientific Sessions