Background: Obesity impacts 25%-45% of domestic cats, with no approved pharmacological therapy. This study evaluated HDM7006, a first-in-class (FIC) dual GLP-1R/GIPR agonist, for its potential in managing feline obesity.
Animals: Phase I enrolled 48 adult cats and Phase II/III enrolled 133 and 128 obese cats, respectively.
Methods: In Phase I, cats received a single subcutaneous (SC) injection at four doses (0.1, 0.5, 1.0, and 2.0 mg/kg), a single intravenous dose of 1.0 mg/kg, and five repeated weekly SC injections at 0.5 mg/kg to characterize HDM7006 PK. In Phase II/III, obese cats received HDM7006 or placebo subcutaneously once weekly for consecutive six weeks, with phase II testing three escalating dose regimens (final doses: 0.1, 0.25, and 0.5 mg/kg) and phase III using the high dose. Body weight, body condition score, and safety were monitored.
Results: PK profile of HDM7006 in adult cats showed no gender differences. Linear PK was observed after SC administration, with a half-life (39.8-47.1 hr) supporting weekly dosing, and good bioavailability (42-78%). No drug accumulation occurred with repeated SC dosing. In Phase II, HDM7006 induced dose-dependent weight loss by Day 42 (low/medium/high dose: -4.51%, -8.01%, -12.41%; placebo: -0.24%). This efficacy was confirmed in Phase III (HDM7006: -9.26%; placebo: +3.67%). The treatment was well tolerated, the adverse events were limited to transient vomiting and dose-related decrease in food intake.
Conclusions: HDM7006 exhibited favorable PK properties supporting QW SC administration, and induced potent, dose-dependent weight loss in obese cats, highlighting its potential as a promising pharmacological treatment for feline obesity.
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