Innovent Biologics Inc. (IVBXF,1801.HK) announced that its Phase 1b clinical trial of mazdutide injection (IBI362), a GLP-1 and glucagon dual receptor agonist, in Chinese adolescents with obesity successfully met its primary endpoint.
The multicenter, randomized, double-blind, placebo-controlled study enrolled 36 adolescents aged 12-18 years who met national obesity criteria. Participants had previously undergone diet and exercise interventions but achieved less than 5% BMI reduction. They were randomized to receive mazdutide 4 mg, mazdutide 6 mg, or placebo for 12 weeks.
Results showed significant reductions in BMI and body weight in the mazdutide groups compared to placebo. The 4 mg and 6 mg groups achieved BMI reductions of 8.78% and 10.99%, and weight reductions of 7.72 kg and 8.65 kg, respectively. In contrast, the placebo group saw only a 1.73% BMI reduction and 1.42 kg weight loss. Improvements were also observed in metabolic parameters such as waist circumference, blood pressure, blood lipids, liver enzymes, and glycemic control.
Mazdutide demonstrated a favorable safety and tolerability profile. All subjects completed the study, with no serious adverse events reported and no discontinuations due to adverse events. The most common side effects were mild to moderate gastrointestinal reactions. Pharmacokinetic data showed similar exposure levels between adolescents and adults.
The findings highlight the urgent need for effective treatments, as adolescent obesity rates in China have surged dramatically over recent decades. Currently, no weight-loss medications are approved for children or adolescents in China. Innovent plans to initiate a Phase 3 registrational trial to further evaluate mazdutide in this population, aiming to address a significant unmet clinical need.
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