US2014024586A1PendingUtilityA1

Use of an fgf-21 compound and a glp-1 compound for the treatment of obesity

56
Assignee: LILLY CO ELIPriority: Aug 3, 2007Filed: Oct 3, 2013Published: Jan 23, 2014
Est. expiryAug 3, 2027(~1.1 yrs left)· nominal 20-yr term from priority
A61P 3/10A61P 43/00A61P 3/04A61K 38/1825A61K 38/26
56
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Claims

Abstract

The present invention provides methods of lowering body weight by administering an FGF-21 compound in combination with a GLP- 1 compound. In addition, the present invention also provides methods to treat obesity by administering an FGF- 21 compound in combination with a GLP- 1 compound. The present invention also discloses combinations useful in the methods of the present invention.

Claims

exact text as granted — not AI-modified
1 - 15 . (canceled) 
     
     
         16 . A method of treating diabetes comprising administering an FGF-21 compound in combination with a GLP-1 compound, wherein the GLP-1 compound comprises an amino acid sequence of SEQ ID NO: 20: 
       
         
           
                 
               
                   His Xaa Glu Gly Thr Phe Thr Ser Asp Val Ser Ser 
                 
                              10                  15 
                 
                     
                 
                   Tyr Leu Glu Xaa Gln Ala Ala Lys Glu Phe Ile Ala 
                 
                       20                  25                  30 
                 
                     
                 
                   Trp Leu Xaa Lys Gly Gly Pro Ser Ser Gly Ala Pro 
                 
                                   35                  40 
                 
                     
                 
                   Pro Pro Cys Xaa 
                 
                           45 
                 
             
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
         wherein 
         Xaa at position 8 is: D-Ala, Gly, Val, Leu, Ile, Ser, or Thr, 
         Xaa at position 22 is: Gly, Glu, Asp, or Lys; 
         Xaa at position 33 is: Val or Ile 
         Xaa at position 46 is: Cys or Cys-NH 2    
         and wherein one PEG molecule is covalently attached to Cys 45  and one PEG molecule is covalently attached to Cys 46  or Cys 46 -NH 2 . 
       
     
     
         17 . A method of treating diabetes comprising administering an FGF-21 compound in combination with a GLP-1 compound, wherein the GLP-1 compound is a fusion protein comprising a GLP-1 analog fused via a linker to an FC portion of an immunoglobulin, wherein the GLP-1 analog comprises an amino acid sequence of SEQ ID NO:22: 
       
         
           
                 
               
                   His Xaa Glu Gly Thr Phe Thr Ser Asp Val Ser Ser 
                 
                               10                  15 
                 
                     
                 
                   Tyr Leu Glu Glu Gln Ala Ala Lys Glu Phe Ile Ala 
                 
                       20                  25                  30 
                 
                     
                 
                   Trp Leu Xaa Xaa Gly Gly Xaa 
                 
                                   35 
                 
             
                
                
                
                
                
                
                
                
               
            
           
         
         wherein 
         Xaa at position 8 is Gly or Val; 
         Xaa at position 33 is Val or Lys; 
         Xaa at position 34 is Lys or Asn; 
         Xaa at position 37 is Gly, Pro or is absent; 
         the linker comprises an amino acid sequence of SEQ ID NO:6: Gly-Gly-Gly-Gly-Ser-Gly-Gly-Gly-Gly-Ser-Gly-Gly-Gly-Gly-Ser, 
         and the Fc portion comprises an amino acid sequence of SEQ ID NO: 23: 
       
       
         
           
                 
               
                   Ala Glu Ser Lys Tyr Gly Pro Pro Cys Pro Pro Cys 
                 
                                   5                   10 
                 
                     
                 
                   Pro Ala Pro Xaa Xaa Xaa Gly Gly Pro Ser Val Phe 
                 
                           15                  20 
                 
                     
                 
                   Leu Phe Pro Pro Lys Pro Lys Asp Thr Leu Met Ile 
                 
                   25                  30                  35 
                 
                     
                 
                   Ser Arg Thr Pro Glu Val Thr Cys Val Val Val Asp 
                 
                               40                  45 
                 
                     
                 
                   Val Ser Gln Glu Asp Pro Glu Val Gln Phe Asn Trp 
                 
                       50                  55                  60 
                 
                     
                 
                   Tyr Val Asp Gly Val Glu Val His Asn Ala Lys Thr 
                 
                                   65                  70 
                 
                     
                 
                   Lys Pro Arg Glu Glu Gln Phe Xaa Ser Thr Tyr Arg 
                 
                           75                  80 
                 
                     
                 
                   Val Val Ser Val Leu Thr Val Leu His Gln Asp Trp 
                 
                   85                  90                  95 
                 
                     
                 
                   Leu Asn Gly Lys Glu Tyr Lys Cys Lys Val Ser Asn 
                 
                               100                 105 
                 
                     
                 
                   Lys Gly Leu Pro Ser Ser Ile Glu Lys Thr Ile Ser 
                 
                       110                 115                 120 
                 
                     
                 
                   Lys Ala Lys Gly Gln Pro Arg Glu Pro Gln Val Tyr 
                 
                                  125                  130 
                 
                     
                 
                   Thr Leu Pro Pro Ser Gln Glu Glu Met Thr Lys Asn 
                 
                           135                 140 
                 
                     
                 
                   Gln Val Ser Leu Thr Cys Leu Val Lys Gly Phe Tyr 
                 
                   145                 150                 155 
                 
                     
                 
                   Pro Ser Asp Ile Ala Val Glu Trp Glu Ser Asn Gly 
                 
                               160                 165 
                 
                     
                 
                   Gln Pro Glu Asn Asn Tyr Lys Thr Thr Pro Pro Val 
                 
                       170                 175                 180 
                 
                     
                 
                   Leu Asp Ser Asp Gly Ser Phe Phe Leu Tyr Ser Arg 
                 
                                   185                 190 
                 
                     
                 
                   Leu Thr Val Asp Lys Ser Arg Trp Gln Glu Gly Asn 
                 
                           195                 200 
                 
                     
                 
                   Val Phe Ser Cys Ser Val Met His Glu Ala Leu His 
                 
                   205                 210                 215 
                 
                     
                 
                   Asn His Tyr Thr Gln Lys Ser Leu Ser Leu Ser Leu 
                 
                               220                 225 
                 
                     
                 
                   Gly Xaa 
                 
                       230 
                 
             
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
         wherein: 
         Xaa at position 16 is Pro or Glu; 
         Xaa at position 17 is Phe, Val, or Ala; 
         Xaa at position 18 is Leu, Glu, or Ala; 
         Xaa at position 80 is Asn or Ala; and 
         Xaa at position 230 is Lys or is absent. 
       
     
     
         18 . A method of lowering blood glucose levels comprising administering an FGF-21 compound in combination with a GLP-1 compound, wherein the GLP-1 compound comprises an amino acid sequence of SEQ ID NO: 20: 
       
         
           
                 
               
                   His Xaa Glu Gly Thr Phe Thr Ser Asp Val Ser Ser 
                 
                              10                  15 
                 
                     
                 
                   Tyr Leu Glu Xaa Gln Ala Ala Lys Glu Phe Ile Ala 
                 
                       20                  25                  30 
                 
                     
                 
                   Trp Leu Xaa Lys Gly Gly Pro Ser Ser Gly Ala Pro 
                 
                                   35                  40 
                 
                     
                 
                   Pro Pro Cys Xaa 
                 
                           45 
                 
             
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
         wherein 
         Xaa at position 8 is: D-Ala, Gly, Val, Leu, Ile, Ser, or Thr, 
         Xaa at position 22 is: Gly, Glu, Asp, or Lys; 
         Xaa at position 33 is: Val or Ile 
         Xaa at position 46 is: Cys or Cys-NH 2    
         and wherein one PEG molecule is covalently attached to Cys 45  and one PEG molecule is covalently attached to Cys 46  or Cys 46 -NH 2 . 
       
     
     
         19 . A method of lowering blood glucose levels comprising administering an FGF-21 compound in combination with a GLP-1 compound, wherein the GLP-1 compound is a fusion protein comprising a GLP-1 analog fused via a linker to an FC portion of an immunoglobulin, wherein the GLP-1 analog comprises an amino acid sequence of SEQ ID NO: 22: 
       
         
           
                 
               
                   His Xaa Glu Gly Thr Phe Thr Ser Asp Val Ser Ser 
                 
                               10                  15 
                 
                     
                 
                   Tyr Leu Glu Glu Gln Ala Ala Lys Glu Phe Ile Ala 
                 
                       20                  25                  30 
                 
                     
                 
                   Trp Leu Xaa Xaa Gly Gly Xaa 
                 
                                   35 
                 
             
                
                
                
                
                
                
                
                
               
            
           
         
         wherein 
         Xaa at position 8 is Gly or Val; 
         Xaa at position 33 is Val or Lys; 
         Xaa at position 34 is Lys or Asn; 
         Xaa at position 37 is Gly, Pro or is absent; 
         the linker comprises an amino acid sequence of SEQ ID NO:6: Gly-Gly-Gly-Gly-Ser-Gly-Gly-Gly-Gly-Ser-Gly-Gly-Gly-Gly-Ser, 
         and the Fc portion comprises an amino acid sequence of SEQ ID NO:23: 
       
       
         
           
                 
               
                   Ala Glu Ser Lys Tyr Gly Pro Pro Cys Pro Pro Cys 
                 
                                   5                   10 
                 
                     
                 
                   Pro Ala Pro Xaa Xaa Xaa Gly Gly Pro Ser Val Phe 
                 
                           15                  20 
                 
                     
                 
                   Leu Phe Pro Pro Lys Pro Lys Asp Thr Leu Met Ile 
                 
                   25                  30                  35 
                 
                     
                 
                   Ser Arg Thr Pro Glu Val Thr Cys Val Val Val Asp 
                 
                               40                  45  
                 
                     
                 
                   Val Ser Gln Glu Asp Pro Glu Val Gln Phe Asn Trp 
                 
                       50                  55                  60 
                 
                     
                 
                   Tyr Val Asp Gly Val Glu Val His Asn Ala Lys Thr 
                 
                                   65                  70 
                 
                     
                 
                   Lys Pro Arg Glu Glu Gln Phe Xaa Ser Thr Tyr Arg 
                 
                           75                  80 
                 
                     
                 
                   Val Val Ser Val Leu Thr Val Leu His Gln Asp Trp 
                 
                   85                  90                  95 
                 
                     
                 
                   Leu Asn Gly Lys Glu Tyr Lys Cys Lys Val Ser Asn 
                 
                               100                 105  
                 
                     
                 
                   Lys Gly Leu Pro Ser Ser Ile Glu Lys Thr Ile Ser 
                 
                       110                 115                 120 
                 
                     
                 
                   Lys Ala Lys Gly Gln Pro Arg Glu Pro Gln Val Tyr 
                 
                                  125                  130 
                 
                     
                 
                   Thr Leu Pro Pro Ser Gln Glu Glu Met Thr Lys Asn 
                 
                           135                 140 
                 
                     
                 
                   Gln Val Ser Leu Thr Cys Leu Val Lys Gly Phe Tyr 
                 
                   145                 150                 155 
                 
                     
                 
                   Pro Ser Asp Ile Ala Val Glu Trp Glu Ser Asn Gly 
                 
                               160                 165 
                 
                     
                 
                   Gln Pro Glu Asn Asn Tyr Lys Thr Thr Pro Pro Val 
                 
                       170                 175                 180 
                 
                     
                 
                   Leu Asp Ser Asp Gly Ser Phe Phe Leu Tyr Ser Arg 
                 
                                   185                 190 
                 
                     
                 
                   Leu Thr Val Asp Lys Ser Arg Trp Gln Glu Gly Asn 
                 
                           195                 200 
                 
                     
                 
                   Val Phe Ser Cys Ser Val Met His Glu Ala Leu His 
                 
                   205                 210                 215 
                 
                     
                 
                   Asn His Tyr Thr Gln Lys Ser Leu Ser Leu Ser Leu 
                 
                               220                 225 
                 
                     
                 
                   Gly Xaa 
                 
                       230 
                 
             
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
         wherein: 
         Xaa at position 16 is Pro or Glu; 
         Xaa at position 17 is Phe, Val, or Ala; 
         Xaa at position 18 is Leu, Glu, or Ala; 
         Xaa at position 80 is Asn or Ala; and 
         Xaa at position 230 is Lys or is absent. 
       
     
     
         20 . The method according to  claim 16 , wherein the FGF21 compound comprises an amino acid sequence comprising a cysteine substitution at positions 21, 26, 33, 118, 119, 121, 122, or 134 of FGF-21 (SEQ ID NO: 2). 
     
     
         21 . The method according to  claim 17 , wherein the FGF21 compound comprises an amino acid sequence comprising a cysteine substitution at positions 21, 26, 33, 118, 119, 121, 122, or 134 of FGF-21 (SEQ ID NO: 2). 
     
     
         22 . The method according to  claim 18 , wherein the FGF21 compound comprises an amino acid sequence comprising a cysteine substitution at positions 21, 26, 33, 118, 119, 121, 122, or 134 of FGF-21 (SEQ ID NO: 2). 
     
     
         23 . The method according to  claim 19 , wherein the FGF21 compound comprises an amino acid sequence comprising a cysteine substitution at positions 21, 26, 33, 118, 119, 121, 122, or 134 of FGF-21 (SEQ ID NO: 2).

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