The double-blind, randomised, placebo-controlled trial is designed to assess the safety and efficacy of a 9mg dose of mazdutide in 80 obese subjects.
These subjects were randomised into a 3:1 ratio to receive either mazdutide or placebo.
The percent change in body weight following treatment with mazdutide after 24 weeks from baseline is the trial’s primary endpoint.
The trial was extended to 48 weeks in participants who were treated for another 24 weeks.
In May this year, the trial had met the primary endpoint.
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Findings showed that mazdutide offered a placebo-adjusted mean body weight loss of 18.6% from baseline after treatment for 48 weeks.
A substantially higher number of participants attained weight loss in the range of ≥15% and ≥20% at 48 weeks versus 24 weeks.
A favourable safety and tolerability profile was reported without any serious adverse events through 48 weeks of the trial.
Furthermore, treatment with mazdutide for 24 weeks offered a decline in liver fat content by 73.3% in people with baseline liver fat content of more than 5%.
Mazdutide also offered a 45.5% decline in ALT levels relative versus placebo following 24-week treatment.
These metabolic benefits also sustained through 48 weeks.
Innovent clinical development vice-president Dr Lei Qian said: “The weight loss effect is even comparable to that of metabolic surgery, and is also the highest placebo-adjusted weight loss among the current GLP-1 drugs in Chinese subjects after 48 weeks of treatment.
“Mazdutide 9mg also provided additional benefits, such as reduced waist circumference, blood pressure, blood lipids, liver fat content, ALT and serum uric acid in subjects with obesity.”
The company plans to commence a Phase III trial of mazdutide 9mg in Chinese participants with obesity by the end of this year.
Earlier this month, Innovent dosed the first subject in the Phase III STAR clinical trial of efdamrofusp alfa (IBI302) for neovascular age-related macular degeneration (nAMD).