US2011034373A1PendingUtilityA1

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

Assignee: LILLY CO ELIPriority: Aug 3, 2007Filed: Jul 30, 2008Published: Feb 10, 2011
Est. expiryAug 3, 2027(~1 yrs left)· nominal 20-yr term from priority
A61P 3/10A61P 3/04A61P 43/00A61K 38/26A61K 38/1825
61
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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 obesity comprising administering an FGF-21 compound in combination with a GLP-1 compound, wherein the FGF-21 compound is an FGF-21 analog selected from the group consisting of Cys 118 -Cys 134 -FGF-21 (SEQ ID NO: 9), Cys 118 -Cys 134 -Ala 167 -FGF-21 (SEQ ID NO: 10), Cys 21 -Cys 33 -Ala 167 -FGF-21 (SEQ ID NO: 11), Cys 26 -Cys 122 -Ala 167 -FGF-21 (SEQ ID NO: 12), and Cys 118 -Cys 134 -Ala 121 -Ala 167 -FGF-21 (SEQ ID NO: 13). 
     
     
         17 . The method according to  claim 16 , wherein the FGF-21 analog is Cys 118 -Cys 134 -Ala 167 -FGF-21 (SEQ ID NO: 10). 
     
     
         18 . The method according to  claim 16 , wherein the FGF-21 analog is Cys 118 -Cys 134 -Ala 121 -Ala 167 -FGF-21 (SEQ ID NO: 13). 
     
     
         19 . The method according to  claim 16 , wherein the GLP-1 compound is a GLP-1 analog which comprises an amino acid sequence of SEQ ID NO: 14: 
       
         
           
                 
                 
               
                     
                   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 Xaa Gly Xaa Xaa Xaa Xaa Xaa Xaa Xaa 
                 
                     
                                   35                  40 
                 
                     
                     
                 
                     
                   Xaa Xaa Xaa 
                 
                     
                           45 
                 
             
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
         wherein 
         Xaa at position 8 is Gly, Ala, or Val, 
         Xaa at position 22 is Gly, Glu, Asp, or Lys, 
         Xaa at position 33 is Val or Ile, 
         Xaa at position 34 is Lys or Arg, 
         Xaa at position 36 is Arg or Gly, 
         Xaa at position 37 is selected from the group consisting of NH 2 , Gly and Pro, 
         Xaa at position 38 is Ser or absent, 
         Xaa at position 39 is Ser or absent, 
         Xaa at position 40 is Gly or absent, 
         Xaa at position 41 is Ala or absent, 
         Xaa at position 42 is Pro or absent, 
         Xaa at position 43 is Pro or absent, 
         Xaa at position 44 is Pro or absent, and 
         Xaa at position 45 is Ser or absent. 
       
     
     
         20 . The method according to  claim 19 , wherein the GLP-1 analog comprises the amino acid sequence of Val 8 -Glu 22 -GLP-1 (SEQ ID NO: 17). 
     
     
         21 . The method according to  claim 19 , wherein the GLP-1 analog comprises the amino acid sequence of Val 8 -Glu 22 -Ile 33 -Lys 34 -Gly 36 -Pro 37 -Ser 38 -Ser 39 -Gly 40 -Ala 41 -Pro 42 -Pro 43 -Pro 44 -Ser 45 -GLP-1 (SEQ ID NO: 19). 
     
     
         22 . The method according to  claim 16 , wherein the GLP-1 compound is a GLP-derivative. 
     
     
         23 . The method according to  claim 22 , wherein the GLP-1 derivative 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 . 
       
     
     
         24 . The method according to  claim 16 , wherein the GLP-1 compound is a GLP-1 fusion protein. 
     
     
         25 . The method according to  claim 24 , wherein the GLP-1 fusion protein comprises a GLP-1 peptide and an Fc portion of an immunoglobulin, wherein the GLP-1 peptide 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; 
         and wherein the GLP-1 peptide is fused to the Fc portion of an immunoglobulin comprising the 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. 
       
     
     
         26 . The method according to  claim 25 , wherein the GLP-1 fusion protein further comprises a linker, wherein the linker comprises an amino acid sequence selected from the group consisting of SEQ ID NO:6, SEQ ID NO;7, and SEQ ID NO:8. 
     
     
         27 . A method of lowering body weight comprising administering an FGF-21 compound in combination with a GLP-1 compound, wherein the FGF-21 compound is an FGF-21 analog selected from the group consisting of Cys 118 -Cys 134 -FGF-21 (SEQ ID NO: 9), Cys 118 -Cys 134 -Ala 167 -FGF-21 (SEQ ID NO: 10), Cys 21 -Cys 33 -Ala 167 -FGF-21 (SEQ ID NO: 11), Cys 26 -Cys 122 -Ala 167 -FGF-21 (SEQ ID NO: 12), and Cys 118 -Cys 134 -Ala 121 -Ala 167 -FGF-21 (SEQ ID NO: 13). 
     
     
         28 . The method according to  claim 27 , wherein the FGF-21 analog is Cys 118 -Cys 134 -Ala 167 -FGF-21 (SEQ ID NO: 10). 
     
     
         29 . The method according to  claim 27 , wherein the FGF-21 analog is Cys 118 -Cys 134 -Ala 121 -Ala 167 -FGF-21 (SEQ ID NO: 13). 
     
     
         30 . The method according to  claim 27 , wherein the GLP-1 compound is a GLP-1 analog which comprises an amino acid sequence of SEQ ID NO: 14: 
       
         
           
                 
                 
               
                     
                   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 Xaa Gly Xaa Xaa Xaa Xaa Xaa Xaa Xaa 
                 
                     
                                   35                  40 
                 
                     
                     
                 
                     
                   Xaa Xaa Xaa 
                 
                     
                           45 
                 
             
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
         wherein 
         Xaa at position 8 is Gly, Ala, or Val, 
         Xaa at position 22 is Gly, Glu, Asp, or Lys, 
         Xaa at position 33 is Val or Ile, 
         Xaa at position 34 is Lys or Arg, 
         Xaa at position 36 is Arg or Gly, 
         Xaa at position 37 is selected from the group consisting of NH 2 , Gly and Pro, 
         Xaa at position 38 is Ser or absent, 
         Xaa at position 39 is Ser or absent, 
         Xaa at position 40 is Gly or absent, 
         Xaa at position 41 is Ala or absent, 
         Xaa at position 42 is Pro or absent, 
         Xaa at position 43 is Pro or absent, 
         Xaa at position 44 is Pro or absent, and 
         Xaa at position 45 is Ser or absent. 
       
     
     
         31 . The method according to  claim 30 , wherein the GLP-1 analog comprises the amino acid sequence of Val 8 -Glu 22 -GLP-1 (SEQ ID NO: 17). 
     
     
         32 . The method according to  claim 30 , wherein the GLP-1 analog comprises the amino acid sequence of Val 8 -Glu 22 -Ile 33 -Lys 34 -Gly 36 -Pro 37 -Ser 38 -Ser 39 -Gly 40 -Ala 41 -Pro 42 -Pro 43 -Pro 44 -Ser 45 -GLP-1 (SEQ ID NO: 19). 
     
     
         33 . The method according to  claim 27 , wherein the GLP-1 compound is a GLP-1 derivative. 
     
     
         34 . The method according to  claim 33 , wherein the GLP-1 derivative 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 . 
       
     
     
         35 . The method according to  claim 27 , wherein the GLP-1 compound is a GLP-1 fusion protein. 
     
     
         36 . The method according to  claim 35 , wherein the GLP-1 fusion protein comprises a GLP-1 peptide and an Fc portion of an immunoglobulin wherein the GLP-1 peptide 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; 
         and wherein the GLP-1 peptide is fused to the Fc portion of an immunoglobulin comprising the 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. 
       
     
     
         37 . The method according to  claim 36 , wherein the GLP-1 fusion protein further comprises a linker, wherein the linker comprises an amino acid sequence selected from the group consisting of SEQ ID NO:6, SEQ ID NO:7, and SEQ ID NO:8.

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