After 12 weeks of treatment, the 4 mg and 6 mg mazdutide groups achieved reductions in BMI from baseline of 8.78% and 10.99%, respectively, with corresponding body weight reductions of 7.72 kg and 8.65 kg. These results were significantly superior to those observed in the placebo group (BMI reduction: 1.73%; weight reduction: 1.42 kg; with nominal P values < 0.01). Furthermore, multiple metabolic parameters improved simultaneously. Mazdutide demonstrated a favorable overall safety and tolerability profile. All enrolled subjects completed the protocol-specified visits. Throughout the study period, there were no serious adverse events (SAEs) reported in the mazdutide groups, and no subjects discontinued treatment due to adverse events (AEs). there are currently no approved weight-loss medications specifically indicated for children and adolescents in China. A Phase 3 registrational clinical trial for adolescent obesity is scheduled to be initiated soon.
SAN FRANCISCO and SUZHOU, China, Dec. 11, 2025 /PRNewswire/ — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, announced that the Phase 1b clinical study of mazdutide injection (a glucagon-like peptide-1 [GLP-1] and glucagon [GCG] dual receptor agonist, R&D code: IBI362) in Chinese adolescents with obesity met its primary endpoint.
The global issue of childhood and adolescent obesity continues to escalate. According to a UNICEF report, the global obesity rate among children and adolescents aged 5–19 has risen from 3% to 9.4% since the year 2000. Obesity has now become a more prevalent form of malnutrition than underweight, affecting one in every ten school-aged children and adolescents (approximately 188 million individuals) and placing them at risk for severe health conditions [1].
The situation regarding obesity prevention and control among Chinese children and adolescents is equally severe. The combined detection rate of overweight and obesity among children and adolescents aged 7–18 in China surged from 1.2% in 1985 to 23.4% in 2019—an 18.1-fold increase. Notably, the obesity detection rate alone soared from 0.1% in 1985 to 9.6% in 2019, representing a staggering 75.6-fold rise [2].
Adolescent obesity is associated with numerous long-term health risks, including hypertension, dyslipidemia, type 2 diabetes, metabolic syndrome, and psychological and behavioral issues. Furthermore, there are currently no approved weight-loss medications specifically indicated for children and adolescents in China [3], highlighting a significant unmet clinical need.
This study is a multicenter, randomized, double-blind, placebo-controlled Phase 1b clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and weight-loss efficacy of mazdutide in Chinese adolescents with obesity. A total of 36 adolescent participants (≥12 and