The effects of LY2405319, an FGF21 Analog, in obese human subjects with type 2 diabetes

Gregory Gaich, Jenny Y. Chien, Haoda Fu, Leonard C. Glass, Mark A. Deeg, William L. Holland, Alexei Kharitonenkov, Thomas Bumol, Holger K. Schilske, David E. Moller

Research output: Contribution to journalArticlepeer-review

642 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)333-340
Number of pages8
JournalCell Metabolism
Issue number3
StatePublished - Sep 3 2013

ASJC Scopus subject areas

  • Physiology
  • Molecular Biology
  • Cell Biology


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