Innovent Biologics, Inc. (HKEX: 01801), a China-based biopharmaceutical company, announced on Thursday that it has met its primary endpoint in 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).
This study, a multicentre, randomised, double-blind, placebo-controlled Phase 1b clinical trial, was designed to assess the safety, tolerability, pharmacokinetics, and weight-loss efficacy of mazdutide in Chinese adolescents with obesity.
The study enrolled a total of 36 adolescent participants (aged over 12 but under 18 years old) with obesity. All participants had undergone dietary and exercise intervention for around 12 weeks prior to enrolment but achieved less than five percent reduction in body mass index (BMI).
According to the company, study results demonstrate that mazdutide, administered via weekly multiple subcutaneous injections following a dose-titration regimen, exhibited a favourable overall safety and tolerability profile in Chinese adolescent participants with obesity. All subjects completed the protocol-specified visits. No serious adverse events (SAEs) were reported in the mazdutide treatment groups during the study period, and no subjects discontinued the study due to adverse events (AEs).
The company says that after the 12-week treatment period for Chinese adolescents with obesity, the mazdutide treatment groups demonstrated statistically significant reductions in both key efficacy endpoints - BMI and body weight - confirming the weight-loss efficacy of mazdutide in this population.
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