TY - JOUR
T1 - The effects of LY2405319, an FGF21 Analog, in obese human subjects with type 2 diabetes
AU - Gaich, Gregory
AU - Chien, Jenny Y.
AU - Fu, Haoda
AU - Glass, Leonard C.
AU - Deeg, Mark A.
AU - Holland, William L.
AU - Kharitonenkov, Alexei
AU - Bumol, Thomas
AU - Schilske, Holger K.
AU - Moller, David E.
PY - 2013/9/3
Y1 - 2013/9/3
N2 - Summary Fibroblast growth factor 21 (FGF21) is a recently discovered metabolic regulator. Exogenous FGF21 produces beneficial metabolic effects in animal models; however, the translation of these observations to humans has not been tested. Here, we studied the effects of LY2405319 (LY), a variant of FGF21, in a randomized, placebo-controlled, double-blind proof-of-concept trial in patients with obesity and type 2 diabetes. Patients received placebo or 3, 10, or 20 mg of LY daily for 28 days. LY treatment produced significant improvements in dyslipidemia, including decreases in low-density lipoprotein cholesterol and triglycerides and increases in high-density lipoprotein cholesterol and a shift to a potentially less atherogenic apolipoprotein concentration profile. Favorable effects on body weight, fasting insulin, and adiponectin were also detected. However, only a trend toward glucose lowering was observed. These results indicate that FGF21 is bioactive in humans and suggest that FGF21-based therapies may be effective for the treatment of selected metabolic disorders.
AB - Summary Fibroblast growth factor 21 (FGF21) is a recently discovered metabolic regulator. Exogenous FGF21 produces beneficial metabolic effects in animal models; however, the translation of these observations to humans has not been tested. Here, we studied the effects of LY2405319 (LY), a variant of FGF21, in a randomized, placebo-controlled, double-blind proof-of-concept trial in patients with obesity and type 2 diabetes. Patients received placebo or 3, 10, or 20 mg of LY daily for 28 days. LY treatment produced significant improvements in dyslipidemia, including decreases in low-density lipoprotein cholesterol and triglycerides and increases in high-density lipoprotein cholesterol and a shift to a potentially less atherogenic apolipoprotein concentration profile. Favorable effects on body weight, fasting insulin, and adiponectin were also detected. However, only a trend toward glucose lowering was observed. These results indicate that FGF21 is bioactive in humans and suggest that FGF21-based therapies may be effective for the treatment of selected metabolic disorders.
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U2 - 10.1016/j.cmet.2013.08.005
DO - 10.1016/j.cmet.2013.08.005
M3 - Article
C2 - 24011069
AN - SCOPUS:84883481988
SN - 1550-4131
VL - 18
SP - 333
EP - 340
JO - Cell Metabolism
JF - Cell Metabolism
IS - 3
ER -