Clinical Protocols

Please see below for active and completed clinical protocols (PI only):

Active Clinical Protocols (PI only)

  • HUM00124256 - A 12-Week, Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy Safety and Tolerability of Gemcabene in Subjects with Severe Hypertriglyceridemia, January 4, 2017
  • HUM00123195 - Burden of Generalized and Severe Partial Lipodystrophy and Potential Survival Benefits of Metreleptin, December 19, 2016
  • HUM00118592 - MEASuRE: Metreleptin Effectiveness and Safety Registry, August 26, 2016
  • HUM00102868 - A Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study of ISIS 304801 Administered Subcutaneously to Patients with Partial Lipodystrophy, September 30, 2015
  • HUM00099360 - Relationship Between Hepatic Steatosis and Relative Leptin Deficiency Among African Americans in the Jackson Heart Study, March 3, 2015
  • HUM00093399 - Clinical Protocol to Investigate the Long-Term Safety and Efficacy of Recombinant Human Leptin (METRELEPTIN) in Various Forms of Partial Lipodystrophy for Patients Studied Using Grant Funds from 5RO1-DK 088114A1-02. Phase V, November 20, 2014
  • HUM00094843 - Expanded-Access for the Use of Metreleptin in Patients with Partial Lipodystrophy Associated with Diabetes Mellitus or Hypertriglyceridemia, November 20, 2014
  • HUM00079381 - Clinical Protocol to Investigate the Efficacy of Amlexanox vs. Placebo for Treatment of Glucose and Lipid Abnormalities in Obese Type 2 diabetics. Phase II, November 21, 2013
  • HUM00065177 - Amlexanox for Type 2 Diabetes. Phase I, March 21, 2013
  • HUM00062732 - Tissue Banking Program for Lipodystrophic Tissue Obtained During Surgical Procedures at the University of Michigan Hospital, April 2, 2012
  • HUM00058708 - Clinical Protocol to Investigate the Efficacy of Recombinant Human Leptin (Metreleptin) in Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) Associated with Lipodystrophy. Phase IV, March 16, 2012
  • HUM00038637 - Nonalcoholic Steatohepatitis: Is Leptin Deficiency an Etiological Factor? Phase II, December 23, 2010
  • HUM00039734 - EXenatide Study of Cardiovascular Event Lowering Trial (EXSCEL). A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes after Treatment with Exenatide Once Weekly in Patients with Type 2 Diabetes Mellitus Phase 3b/4, September 30, 2010
  • HUM00118592 - Effect of Macrocomposition on NAFLD in Bariatric Surgery Candidates, March 5, 2009
  • HUM00021139 - An Open-label Treatment Protocol to Provide Metreleptin for the Treatment of Diabetes Mellitus and/or Hypertriglyceridemia Associated with Lipodystrophy, January 15, 2009
  • HUM00019137 - Nonalcoholic Steatohepatitis: Is Leptin Deficiency an Etiological Factor? Long-Term Follow-Up. Phase III, July 31, 2008
  • HUM00042388 - Nonalcoholic Steatohepatitis: Is Leptin Deficiency an Etiological Factor? Phase I, September 4, 2003

Completed Clinical Protocols (PI only)

  • HUM00070226 - EndoBarrier: A Novel Therapy for Type 2 Diabetes in Obese Adults., April 11, 2013
  • HUM00036853 - A Trial Comparing the Efficacy and Safety of NN1250, a Soluble Insulin Basal Analogue (SIBA) 200 U/ml and Insulin Glargine in Subjects with Type 2 Diabetes, March 18, 2010
  • HUM00034756 - GLP108486: Safety and Efficacy of Albiglutide Administered in Combination with Insulin Glargine, as Compared with the Combination of Insulin Glargine and Preprandial Lispro Insulin, in Subjects with Type 2 Diabetes Mellitus, February 11, 2010
  • HUM00035049 - An Exploratory Phase 2 Study to Assess the Effect of Dapagliflozin on Glomerular Filtration Rate (GFR) in Subjects with Type 2 Diabetes who have Inadequate Glycemic and Blood Pressure (BP) Control, January 21, 2010
  • HUM00020731 - Exenatide Observational Study in the U.S., May 28, 2008