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Manufacturers suspend study of investigational obesity drug combo
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A phase 2 study designed to explore the safety and efficacy of pramlintide/metreleptin, an investigational combination therapy for the treatment of obesity, has been suspended by the drug manufacturers, according to a company press release. The companies voluntarily stopped the study to investigate a new antibody-related laboratory finding with metreleptin that occurred in two patients who participated in a previous study of obesity.
Pramlintide and metreleptin are manufactured by Amylin Pharmaceuticals, in partnership with Takeda Pharmaceutical Company Limited. Pramlintide acetate, a synthetic analog of the natural hormone amylin, has been administered to about 8,000 individuals in clinical trials, including more than 950 individuals in obesity studies. Metreleptin (methionyl recombinant leptin; r-metHuLeptin) is an analog of human leptin, and more than 1,200 overweight or obese individuals have received metreleptin in clinical trials, several of which were 16 weeks or longer in duration, according to the press release.
According to Amylin, this news will not affect the company’s current lipodystrophy development program to evaluate metreleptin as a treatment for diabetes and/or hypertriglyceridemia in patients with rare forms of lipodystrophy.
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