ONLI}¡E}IOTARY.l\¡ET
`
`*
`
`File name: 769757Affidavit.Pdf
`Document lD: 1 B5AC360-A2B 4-11ED-838C-3358F1 53F3D7
`Status: Gompleted
`
`Docume nt Historv
`
`2023-02-01
`23:43:47 EST
`2023-02-01
`23:53:57 EST
`2023-02-02
`00:12:52 EST
`2023-02-02
`00:12:52 EST
`2023-02-02
`00:12:52 EST
`
`Document uploaded by Nathaniel Frank-White (ridge@archive.org)
`lP: 2001 :569:5827:d200:9878:9d9b:5b1 5:65b1
`Document signed by Nathaniel Frank-White (ridge@archive.org)
`lP: 2001 :569:5827;d200:9878:9d9b:5b1 5:65b1
`Document signed by Nidhi Patel
`lPi 107.23.206.220
`eNotary signed by Nidhi Patel
`lPi 107.23.206.220
`Document delivered to Nathaniel Frank-White(ridge@archive.org) via email.
`lP: 107 .23.206.220
`
`t,,iri
`
`rl,
`
`T
`
`Documsnt ld: 1 B5AC360-4284¡ 1ED-838C-3358F1 53F3D7
`Onì¡neNotary.net
`
`I rilt]ililililllllllillllllllllllllllïlllI
`
`Page 114
`
`MPI EXHIBIT 1013 PAGE 1
`
`MPI EXHIBIT 1013 PAGE 1
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1013, p. 1 of 41
`
`

`

`ARCHIVE
`
`archive.org
`
`AF'F'IDAVIT OF NATHANIEL E FRANK.WHITE
`
`1. I am a Records Request Processor at the Internet Archive. I make this declaration
`of my own personal knowledge.
`2. The Internet Archive is a website that provides access to a digital library of Internet
`sites and other cultural artifacts in digital form. Like a paper library, we provide
`free access to researchers, historians, scholars, and the general public. The Internet
`Archive has partnered with and receives support from various institutions,
`including the Library of Congress.
`
`3. The Internet Archive has created a service known as the Wayback Machine. The
`Wayback Machine makes it possible to browse more than 450 billion pages stored
`in the Internet Archive's web archive. Visitors to the Wayback Machine can search
`archives by URL (i.e., a website address). If archived records for a URL are
`available, the visitor will be presented with a display of available dates. The visitor
`may select one of those dates, and begin browsing an archived version of the Web.
`Links on archived files in the Wayback Machine point to other archived files
`(whether HTML pages of other file types), if any are found for the URL indicated
`by a given link. For instance, the Wayback Machine is designed such that when a
`visitor clicks on a hyperlink on an archived page that points to another URL, the
`visitor will be served the archived file found for the hlperlink's URL with the
`closest available date to the initial file containing the hyperlink.
`
`4. The archived data made viewable and browsable by the Wayback Machine is
`obtained by use of web archiving software that automatically stores copies of files
`available via the Internet, each file preserved as it existed at a particular point in
`time.
`
`5. The Internet Archive assigns a URL on its site to the archived files in the format
`in yyyy][Month in mm][Day in dd][Time code in
`http://web.archive.org/web/lYear
`hh:mm:ss]/[Archived URL] aka an "extended URL''. Thus, the extended URL
`http://web.archive.org/web 119970126045828/http://www.archive.org/ would be the
`URL for the record of the Internet Archive home page HTML file
`(http://www.archive.org/) archived on January 26,1997 at 4:58 a.m' and 28
`seconds (1997101126 at 04:58:28). The date indicated by an extended URL applies
`to a preserved instance of a file for a given URL, but not necessarily to any other
`files linked therein. Thus, in the case of a page constituted by a primary HTML file
`and other separate files (e.g., files with images, audio, multimedia, design
`elements, or other embedded content) linked within that primary HTML file, the
`primary HTML file and the other files will each have their own respective extended
`URLs and may not have been archived on the same dates'
`
`6. Attåched hereto as Exhibit A are true and accurate copies of screenshots of the
`Internet Archive's records of the archived files for the URLs and the dates specified
`in the attached coversheet of each printout.
`
`þ¡
`
`Ðz
`
`Ét
`
`¡¡
`z
`
`Document ld: 1 B5AC360-A2B¡|-1
`Onl¡nêNotary.net
`
`'l ED-838C-3358F1 53F3D7
`
`1ilililililil il ililil|111111il ilÍilillllllllll ll llllllllll lll lll
`
`Pagè214
`
`MPI EXHIBIT 1013 PAGE 2
`
`MPI EXHIBIT 1013 PAGE 2
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1013, p. 2 of 41
`
`

`

`ARCHIVE
`
`F-
`f¡J
`
`7É f
`
`JJ
`
`F-z
`
`arch¡ve,org
`
`7 . I declare under penalty of perjury that the foregoing is true and correct.
`
`DATE:
`
`02/02/2c.23
`
`fkfl*^ ;"I T'*^,J.-W lr;t*
`Nathaniel E Frank-White
`
`All Puryoss
`Jurat form
`for add¡tlonal
`Notary Events
`
`Doqmeñt ld: I B5AC360-4284-l
`OnlinENotary,net
`
`lED-838C-3358F153F3D7
`
`] ilil]ililililtIillillillllilllllillllll
`
`Pagê 3/4
`
`MPI EXHIBIT 1013 PAGE 3
`
`MPI EXHIBIT 1013 PAGE 3
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1013, p. 3 of 41
`
`

`

`IURAT ATTACHMENT
`
`notary public or other officer completing this certificate verifies only the identity of the individual who signed
`document to which this certificate is attached, and not the truthfulness, accuracy, or validity of that
`document.
`
`STATE OF
`
`Texas
`
`)
`
`OF
`
`Harris
`
`The foregoing instrument was subscribed and swom before me this date of
`02/o2/2O23 by
`Frank-White
`
`This notarial act was an online notarization.
`
`*
`
`ot
`
`NIDHIPATEL
`ELECTRONIC NOTARY PUBLIC
`STATE OFTEXAS
`NOTARY lO:13157981ô
`COMISSION EXP: M^Y 2s,2026
`
`(Notary Seal)
`
`Notary's
`
`Registration No.
`
`13$79816
`
`Commission Expiration Date: Mav 23, zoz6
`
`-l
`
`ld: I BsAC360-4284-'l 1 EO-838C-3358F1 53F3D7
`DocumÊnt
`Onlin€Notary-ñêt
`
`ï tililil1ililil]1il1ilil[]tililililililr
`
`Page414
`
`MPI EXHIBIT 1013 PAGE 4
`
`MPI EXHIBIT 1013 PAGE 4
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1013, p. 4 of 41
`
`

`

`EXHIBIT A
`EXHIBIT A
`
`MPI EXHIBIT 1013 PAGE 5
`
`MPI EXHIBIT 1013 PAGE 5
`
`MPI EXHIBIT 1013 PAGE 5
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1013, p. 5 of 41
`
`

`

`http://web.archive.orglwebl20111020123620lhttps:llclinicaltrials.gov/ct2lshow/NCT00696657
`
`MPI EXHIBIT 1013 PAGE 6
`
`MPI EXHIBIT 1013 PAGE 6
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1013, p. 6 of 41
`
`

`

`rllu[[cltilmll¡ru 26 caplgleg
`2ao.12a08. r5^pr2021
`
`ClínícølTríals.gov
`
`A!.d¡.!dth! U-S. H¡on¡l hdM.¡d H.¡lth
`
`fõõl AUG
`
`(Ð@a
`Etr
`2009
`Search Study_Iepig9 Glossary
`8.rtch
`
`Full T.xt v¡.w
`
`Tabular View
`
`No study-EsslttEeglcd
`
`Related Slud¡es
`
`A Randomised Controlled Clinical Trial ln Type 2 Dlabetes Comparing Semaglut¡de to Placebo and Liraglutide
`This study has been comPleted.
`
`First Recêiv€d on June 1 1, 2008. Last Updated on Seplember 22,2011 H¡story-g[..]0¡ê¡ges
`
`Sponsor: Novo Nordisk
`
`lntormatlon provldèd by (Responslblê Partyl: Novo Nordisk
`
`Clln¡ølTr¡als.gov ldenlil¡et: NCT00696657
`
`Þ Purpose
`
`ãnd the tr€âlment duration was '12 week6.
`
`Cond¡tion
`
`Dlabêtes Mell¡tus, Type 2
`
`StudyType: lnterventlonal
`Study Des¡gn: Allocation: Randomized
`Endpoint Classil¡cation ; Safety/Efñcâcy Study
`lnterventlon Model: Pârallel Asslgnmènt
`l\4asking; Double Bl¡nd (Subject, lnvestigâtor)
`Primary PurPose: Trealment
`
`Group, Dose Finding Trial
`
`Resource l¡nks prov¡ded by NLM:
`
`lntervention
`
`Drug: semaglutlde
`Drug: plâcebo
`Drug: llraglutide
`
`Phase
`
`Phase ll
`
`Genet¡cs Home Reference related topics: 0!¡24{elated fansient neonatal diabetes mellìtus
`
`llCdIlCPlgS related topics: Djgþgtes
`oru9 lnformation av8¡lable for: Liraglutide
`
`U.S. FDA Resources
`
`Furthèr study details as provided by Novo Nord¡sk:
`
`Primary Outcome Measures:
`. HbA l c I Tlme Frame: aftèr 1 2 weeks of lreatment ] [ Designated as safety ¡ssue: No ]
`
`Secondary Outcome Measures;
`. Percentage of subiecls w¡th sn adv€r6e êvent6 [ Tme Frame; afteI 12 weeks of treatment ] [ Des¡gnated aE sãtety ¡6sue: No ]
`. Percentagê of subjects with hypoglycâem¡c episode [
`'tlme Frame: after 1 2 weeks of treatment ] [ Dss¡gnated as safety issue: No ]
`. Change from Þaseline in ÊCG Ilime Frame; week 0, week 12 ] [ Designatsd as safely issue; No I
`. Change from basel¡ne ¡n vital signs (Pulse) [ T¡me Framer week 0, week I 2 I I Designated as safety issuê: No ]
`. Change lrom basel¡ne in v¡tal signs (blood pressure) [T¡me Frame: w€ek 0, week 12 ] { Designated as safety issuer No I
`. Change from baseline ¡n standard safety laboralory parameters (haematology) [ T¡me Frame: week 0, week 1 2 I I Des¡gnated as 6alety ¡ssue: No ]
`. Change from basêl¡ne in standard safety laboratory parameters ( b¡ochem¡stry) [ Tlme Frame] week 0, weêk 12 I I Des¡gnated as sâfèty issue: No ]
`. Change lrom baseline in standard safely laboratory parameters (urinalysis) [ Time Frame: week 0, week 12 ] [ Designated âs safely issue: No ]
`. Change lrom baseline ¡n calcitonin I
`.].jme
`Frame: week 0, week 12 I I Des¡gnated as saf€ty issue: No ]
`. Percentageofsubjectsdevelopìnganti- emâglulideantibodieslT]meFrame:afler12weeksoftreatmenllIDesignatedassãfetyissue:No]
`
`Enrollmentr
`415
`Study Start Date:
`June 2008
`Study Completion Date: February 2009
`Primary Completion Date: February 2009 (Final data colleclion date for pr¡mary outcome measure)
`
`Arms
`
`A: Experimental
`lnteryent¡on: Drug: semaglut¡de
`
`B: Exper¡mental
`lnteruention: Drug: semaglutide
`
`C: Expsrimental
`lnterventionr Drug: semaglut¡de
`
`D: Exper¡mental
`lnteruention: Drug: semaglutide
`
`Ass¡gIcd-blClYe¡!þIs
`
`Drug: semaglutide
`0.1 mg, once weekly, s.c. ini€ction
`
`Drug: semaglulide
`0.2 mg, once weekly, s.c. ¡njection
`
`Drug: semaglutide
`0.4 mg, once weekly, s.c. ¡njection
`
`Drug: semaglutide
`0.8 mg, once weekly, s.c. iniect¡on
`
`MPI EXHIBIT 1013 PAGE 7
`
`MPI EXHIBIT 1013 PAGE 7
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1013, p. 7 of 41
`
`

`

`E; Experimental
`lnteruentlon: Drug: somaglutide
`
`F: Experimental
`lntervent¡on: Drug: semaglut¡de
`
`G1: Plsæbo Comparator
`lnterusntion; Drug: placebo
`
`G2: Placebo CompaÞtor
`lnt€ruenlion: Drug; placebo
`
`G3; Placebo comparator
`lntery€ntion: Drug: placebo
`
`G4: Placebo Comparatot
`lntervent¡on: Drug: plâcebo
`
`G5: Plâæbo Comparator
`lnterusnt¡on: Drug: placebo
`
`G6; Plaæbo comparator
`lnteruentlon: Drug: placebo
`
`H: Experlmental
`lnlêrventlon; Drug: llrâglutide
`
`l: Experlmentâl
`lnteruention: Drug: liraglut¡de
`
`Drug; semåglutide
`0.8 mg wllh tltration, onc6 weekly, s.c. injectlon
`
`Drug: semaglutlde
`1.6 mg w¡th titratlon, onæ we€kly, s.c. ¡njectlon
`
`Drug: placobo
`0.1 mg, onc€ weekly, s.c. injecl¡on
`
`Drug: placebo
`0.2 m9, onc€ wâskly, s.c.
`
`lnJectlon
`
`Drug: plâc€bo
`0.4 mg, once weekly, s.c. injectlon
`
`Drug; placebo
`0.8 mg w¡th t¡trátion, onæ wê€kly, s.c. injecllon
`
`Ðrug: plåc€bo
`0.8 mg with tltratlon, once weekly, s.c. injection
`
`Drug; placebo
`1.6 mg, once weekly, s.c. injection
`
`Drug: llraglutide
`1.2 mg wlth tltralion, once da¡ly, s.c. iniectlon
`
`Druo; llraglutide
`1.8 mg wlth tltratlon, once daily, s.c. ¡njectlon
`
`Þ eligiuirity
`Ages Ellg¡ble for Study:
`18 Yeare and older
`Genders Eligible for Study: Both
`Accepts Heâlthy Voluntêers; No
`
`Crll€r¡a
`lnclusion Cr¡ter¡a:
`. Men and women-not-of-chlldbearlng potèntlal dlagnosed with type 2 dlabstss for at leåst threè mônths
`. Ståble û€atmênt regim€n
`(at lèast 1 500 mg) or dlet and exerclss alone for at lsast thr€e months
`w¡th e¡th€r metformln
`. HbAlc:7.0-'10.0 % (both inclusive)
`. Body we¡ght between 60 kg and 110 kg
`Excluslon Crlteriâ:
`
`within the last three months
`. lmpålrèd llvèr or kldney functlon
`. Prol¡feraùve rêtinopathy or maculopâlhy requlrlng acute treâtment
`. Cllnlcally signlliænt actlve ærdiovascular disease and uncontrolled treatêd/untreated hyperlension
`. Rêcurrênt major hypoglyca€mia or hypoglyca€mic
`unawareness
`. Prssenlorplann€dusêofanydrugwh¡chcould¡nt€rferewiththeglucosslev8l$(ê,g.systsmlccorticosteroid6)
`
`Þ Contacts and Locations
`
`Pl€ase
`
`refer to this study by lts CllnlcâlTrlâls.gov ldentfl¡er: NCT00696657
`
`Locations
`
`Austrlâ
`
`W¡en, Austria, 10'10
`
`Bûlgarla
`
`F¡nland
`
`Russe, Bulgarlã,7000
`
`Turku, Finland,20520
`
`Formêr Serbla and Montenêgro
`Belgrâde, Former Serbia and Montenegro, '11000
`
`France
`
`MONTPELLIER cedex 5, France,34295
`
`Germany
`Pohlheim, Germany,35415
`
`Hungary
`
`lndla
`
`Italy
`
`Budapest, Hungary, H-1045
`
`Chennåi, lndia, 600086
`
`Ch¡ell Sælo, ltaly, 66013
`
`South Atrica
`Durban, KwaZulu-Natal, South Africa, 4091
`
`Spain
`
`Almerla, Spaln,04001
`
`Sw¡E€rland
`Genève'14, Switzer¡and,'12'l'l
`
`Turkèy
`
`lstânbul, Turkey, 34390
`
`MPI EXHIBIT 1013 PAGE 8
`
`MPI EXHIBIT 1013 PAGE 8
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1013, p. 8 of 41
`
`

`

`Unltcd Klngdon
`Bexhlll-on-Sêa, United Kingdom, TN39 4SP
`
`Sponsor3 ând Coll¡boratora
`Novo Nordlsk
`
`lnvæt¡g.torr
`Study Dkector: Chrlstins B, Jensn, MD, PhD Novo Nordl6k
`Þ More lnform¡tion
`
`Addlllonal lnformallon:
`
`Clinical Trials at Novo Nordlsk !!!J
`
`No publlcâllon6 provlded
`
`Responslbls Party:
`Cllnlcalïrlals.gov ldentlf er:
`Other Study lD Numbsrs:
`Study First Recèlved:
`Lasl Updated:
`Hèalth Aulhoíty:
`
`Novo Nordisk
`NcT00696657 Hiôtorv of changes
`NN9s35-r821, 2007-003956-'r2
`June l1, 2008
`Ssptember 22, 201'l
`Austrla: Federal Mlnistry lor Health and Womeni Bulgåria: Bulgarlan Drug Ag€nÖy; Flnland: Flnnlsh Medlclnes Agêncy; Francê: AfssapÊ - French Hêålth Productô
`SafetyAgêncy: Germany: Fsderal lnstltute for Drugs ånd Medical Devlcosi Hungery; Nalionâl lnstituts of Phsrmacy; lndia: Minislry of Hsalth; ltâly; Nationål
`for Clinical Trials - Mlnl8try of H€allhi Serbfa: Medlclne6 and Mêdlcâl DsvlcBs Agency of Serbla; Soúth Afrl€: Mediclnes Control Council;
`Mon¡toring C€ntre
`Spain: Spanish Agency of Msd¡cines: Swltzerland: LawE ând standards; Turkey; Mlnlstry of Health; United Kingdom: Msdlclnês and Hsal$car€ Products
`Rêgulatory Agency
`
`Addltlonãl râlêvânt MoSH tErms:
`Dlab6tes Mellltus
`Diabètês Mellitus, Typê 2
`Glucos Metåbol¡sm Dlsorders
`Mstabolic Olssas€s
`Endocrlns System 0i6eaæs
`I
`Glucagon-Llks P€ptide
`
`Clln¡cslTrlals.gov proc€ssed
`
`thls reærd on October 18, 2011
`
`lncrêtlns
`Homones
`Hormones, Hormon€ Substltut€6, and Hormone Antagonists
`Physlologlcål Effects of Drugs
`Ph6rmåcologlc Actions
`
`conbcl HâlLD$h
`I isl€r H¡ll Nãtiomt cqntar for 8ìom€d¡el CommuniÉlion6, U.S. Nâlional L¡brâru of Madicine.
`[J s Nâüonâl lnsìitútes ô{ H6llh, U.S tuÉdmnloltþallhj&-Hl$¡!.1@¡€¡,
`USASQ, Copy¡Shl. edEçy. Àc$sibilily, Fdom or lnfomålion Acl
`
`#m#
`
`MPI EXHIBIT 1013 PAGE 9
`
`MPI EXHIBIT 1013 PAGE 9
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1013, p. 9 of 41
`
`

`

`http://web.archive.orglwebl20l10804021928lhttps:llclinicaltrials.govlct2lshow/NCT00696657
`
`MPI EXHIBIT 1013 PAGE 10
`
`MPI EXHIBIT 1013 PAGE 10
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1013, p. 10 of 41
`
`

`

`lllru[[[lltllmllÌru 26 caplgIeg
`28 ocr 2!08 - 1i
`
`2q21
`
`ClínicalTriøls,gov
`
`¡r.ruicr orthr U.S. Nilon¡l hllM.3 ot Hdlth
`
`l-õãl JUN
`
`ocr
`
`(Doa
`EE¡
`
`2009
`2012
`Home Search Study-IgÊigs Glossary
`Scrrch
`
`Full Text Vl¡w
`
`Tåbular V¡ew
`
`No Study_BesrdlrEs$gd
`
`Related studies
`
`A Randomised Controlled Clinical Trial in Type 2 Diabetes Gomparlng Semaglutide to Placebo and Liraglutide
`
`Th¡s study has been completed.
`
`First Rece¡ved on June 1'1,2008. Last Updaled on March 16,201'1 H¡storv ofChanges
`
`Sponsor: Novo Nordisk
`
`lnlormallon prov¡ded by: Novo Nordisk
`
`Cl¡n¡callllals.gov ldentiflèr: NCTo0696657
`
`Þ Purpose
`
`and the treatment duratlon was 12 week6.
`
`Cond¡tion
`
`Diâbetes Mellltus, Type 2
`
`StudyType: lnleruentlonal
`StudyDesign: Alloætlon:Randomiz€d
`Endpoint Classification: Safety/Effi cacy Study
`lnleryentlon Môdel: ParsllelAsslgnment
`Masking: Double Bl¡nd (Subject, lnvestigator)
`Prim6¡y Purposer Treåtment
`
`lnteruent¡on
`
`Drug: semâglutlde
`Drug: placebo
`Drug: liraglutide
`
`Phase
`
`Phase ll
`
`Ofncial ïúle:
`
`lnvestigation of Safety and Efi¡cäcy of Fiv€ Doses of Semaglutide Versus Placebo and Openlâbel Liraglutide, as Add on Therâpy, in Subjects D¡agnosed With
`Currently Treated With Metform¡n or Controlled With Diel and Exercise A 12 Week Mulli-centre, Multi National, Double-blind, Placebo-controlled, Randomis€d.
`Group, Dose Finding Trial
`
`Type
`Nlne
`
`2 Diabêtes
`Armed Parallel
`
`Rêsource l¡nks provided by NLM:
`
`Genet¡cs Hom€ Reference related
`
`top¡cst qq24-related transient neonatal diabet€s mellitus
`
`MedlinePlusrelâtedtopi6: Diâbetes
`
`Drug lnformation availåble for: Liraglutide
`
`U.S. FDA Resources
`
`Further study details âs provided by Novo Nord¡sk;
`
`Primary Outcome Measures:
`. HbAl c I Time Frame: alter '1 2 wseks of treatment I I Designated as sâfety issue; No ]
`
`Secondary Outcome Measures:
`. Percentage of subjects w¡th an adveÍse event6 [ Time Fßme: aftet '12 weeks ol trealment ] I Designated as salêty issuei No l
`. Percenlage of subjects w¡th hypoglycaemic episode I T¡me Frame: after 12 weeks of treatment ] I Designated 8s safêty ¡ssuè: No I
`. Chânge from basel¡ne in EcG I l¡me Frâme: week 0, week 1 2 ] [ Designated as safety issue; No ]
`. Change from baseline in vital signs (Pulse) [ Time Frame: we€k 0, week 12 I I Des¡gnated as safety issue: No ]
`. Change from baseline in vital signs (blood pressure) [ Time Frame: week 0, week 12 ] [ Des¡gnated as safety ¡ssue: No ]
`. Change from baseline ¡n standard safety taboralory parameters (haematology) I Tme Frame: week 0, week 1 2 I I D€signated as safety lssu€: No ]
`. Chânge from basel¡ne in standard safety lâboratory parameters ( biochem¡stry) [ Time Frame: week 0, week 12 ] [ Designated as safety issuê: No ]
`. Change from basel¡ne in standard safety lâboratory parameters (urinalysis) [ Time Frame: week 0, week 1 2 ] [ Designated as safety issue: No ]
`.Iime
`. Change from baseline ¡n calciton¡n I
`Framê: w€ek 0, week 1 2 ] [ Designated as safety issue: No ]
`. Percentage of subjects developing ant¡-semaglut¡de antibodies I Time Frame: ãtler 1 2 weeks of treatment ] [ Designated as safety ¡ssue: No I
`
`Enrollment:
`415
`Study Start Datê:
`June 2008
`Study Complet¡on Dater February 2009
`Primary Complet¡on Date: February 2009 (Final data collection dale for primary outcome measure)
`
`Arms
`
`A: Exper¡mental
`lnteruent¡on: Drug: semaglutide
`
`B: Exper¡mental
`lnteryent¡on; Drug: sêmaglutide
`
`C: Experimenlal
`lnteruent¡onr Drugr semaglut¡de
`
`D; Experimental
`lnteruent¡on: Drug: semaglutide
`
`Ass¡gned lnlêfventions
`
`Drug; semaglutide
`0.1 mg, once weekly, s.c. injection
`
`Drug: sêmaglut¡de
`0.2 mg, once weekly, s.c. ¡nject¡on
`
`Drug: semaglutide
`0.4 mg, once weekly, s.c. ¡njection
`
`Drug: sêmaglutide
`0.8 mg, once weekly, s.c. inject¡on
`
`MPI EXHIBIT 1013 PAGE 11
`
`MPI EXHIBIT 1013 PAGE 11
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1013, p. 11 of 41
`
`

`

`E: Experimental
`lnteruentlon: Drug: semaglutlde
`
`F: Experimental
`lnteruentlon: Drug: semaglutidè
`
`G1: Plâæbo Comparator
`lntsruenlion; Drug: placebo
`
`G2: Placebo Comparator
`placebo
`lnl€rv€ntlon: Drug:
`
`G3: Plac€bo Comparator
`lnteruêntion; Drug: placebo
`
`G4: Placebo Comparator
`lntervent¡on: Drug: placebo
`
`G5r Placebo Comparator
`lnteruention: Drug: placebo
`
`G6: Plâæbo Comparator
`lntervention: Drug: placebo
`
`H: Expsrimental
`Interuentlon: Drug: l¡raglulide
`
`l: Experimental
`lntervêntion: Drug: lkaglulidê
`
`Drug: semaglutide
`0.8 mg with titration, once wèêkly, s.c. lnjectlon
`
`Drug: semaglutide
`1.6 mg w¡th t¡tration, onæ weekly, s.c. injection
`
`Drug: placebo
`
`Drug: placebo
`0.2 mg, once we€kly, s.c. injsction
`
`Drug: plaæbo
`0.4 mg, once weekly, s.c. iniect¡on
`
`Drug: placêbo
`0.9 mg w¡th t¡trat¡on, once weekly, s.c. inj€ction
`
`Drug: placêbo
`0,8 mg wilh tltration, once weekly, s.c. inj€ction
`
`Drug: placebo
`1,6 mg, once weeklf s.c. injeclion
`
`Drug: liraglutide
`'1.2 mg with titratlon, once daily, s.c. lnjecllon
`
`Drug; llraglullde
`'1.8 mg with titratlon, once daily, s.c. ¡njection
`
`Þ erisioiriry
`
`Ages Eligible fôr Study:
`Genders Eliglble tor Study:
`Accepts Healthy Voluntêèr6:
`
`18 Yeârs ånd older
`Bolh
`No
`
`Crltêrla
`lnclusion Crlteria:
`. Mên and women-not-of-chlldb€aring
`thrêe months
`potenllal dlagnosed wlth type 2 d¡abetes for at l€a6t
`. Stable trsatment reglmsn with qlther mstformln (at least 1500 mg) or di€t and exorc¡s€
`alon€ for at lsast three months
`. HbA'lc: 7.0-10.0 o/o (both incluslve)
`. Body weight between 60 kg ând 1 10 kg
`Excluslon Crlteriâ:
`
`withln the last thres months
`. lmpalrêd llver or kidney functlon
`. Prollferâtlve retlnopalhy or mâculopalhy requ¡rlng acute tt6atment
`. Clinically signllìcant active ærdlovâsculâr disease and uncontrolled lreated/untrealed hypertension
`. R€currênt major hypoglycåemiå or hypoglycaemic unawarenoss
`. Pr€sent or planned use of any drug whlch could intsrferê with the glucose l€vsls
`
`(€.9. syst€mic cortiæsteroids)
`
`Þ Gontacts and Locations
`Pl€ase refer to this study by lts CllnlcalTrials.gov ldentlfler: NCT00696657
`
`Locatlont
`
`Austrla
`
`Wlen, Austria, 1010
`
`Bulgaria
`.
`F¡nland
`
`Russe, Bulgarlå,7000
`
`Oulu, Flnland,90029
`
`Formêr Serb¡a and Montenêgro
`Belgrade, Former Serbìa and Montenegro, 11000
`
`France
`
`MONTPELLIER cedex 5, France,34295
`
`Gêmany
`Pohlheim, Germany, 35415
`
`Hungary
`
`lndia
`
`Italy
`
`Budapest, Hungary H-1045
`
`Chennai, lnd¡4,600020
`
`ch¡êtl Sælo, ltaly, 66013
`
`South Aft¡ca
`Cape Town, Western Cape, Soulh Afr¡ca, 7925
`
`Spain
`
`Almería, spain, M001
`
`Sw¡Þerland
`Küsnacht, Switzerland, 8700
`
`Turkey
`
`lstânbul, Turkey, 34390
`
`MPI EXHIBIT 1013 PAGE 12
`
`MPI EXHIBIT 1013 PAGE 12
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1013, p. 12 of 41
`
`

`

`Unlû.d Klngdom
`Bexhlll-on-Seå, United Kingdom, TN39 4SP
`
`Epon¡oE and Collåbotitora
`Novo Nordisk
`
`lnvù3t¡g.lora
`Study Director: Christ¡ne B, Jen6en, MD, PhD Novo Nordisk
`Þ ilore lnformation
`
`Addttlonal lnformatlon:
`
`Cl¡nical Trials st Novo Nordlsk !å[]
`
`No publlcatlons provlded
`
`R€sponslble Party:
`Cllnlcalïrlals.gov ldentifier:
`Oth€r Study lD Numbers:
`Study First Recêlvêd:
`Last Updated:
`Health Authority:
`
`Novo Nordisk A,/S ( Publ¡c Acce6s to Clinlcal Trlals )
`NCT00696657 l-liclaty-afehÊlges
`NN953S. r821, 2007-003956-'l2
`June l1, 2008
`Mârch 16,2011
`Auetria: Fsderal Mlnlstry lor Hóglth and Womsni Bulgarla: Bulgarlan Orug Agency; Flnland: Flnnish Medlclnes Agency; Fràn@; Afssâp6 - Frsnch Hêâlth Products
`Safety Agêncy; Germany: Federal lnstilute for Drugs and Msdlcal Dsvices; Hungary: National lnstltute of Pharmscy; lndla: Minlstry ot Hsalth; ltaly: Nationâl
`for ClinielTrlâlÊ - Ministry of Heallhi Serbia: Mêdlcin€s and Medlæl Devlæs Agsncy of Serbiåi South Afrlæ: Mâdlclnes Control Councll;
`Monftôrlng C€ntre
`Spaln: Spsnish Agoncy of Medlcinss: Swltzsfland: Laws and standardsi Turkey: Ministry ot Health; Unlt€d Klngdom: Mediclnss and H€altlìcare Products
`Regulatory Agency
`
`Additional relavant MèSH lgrms;
`Diabetes Mellltus
`Diabetes Mell¡tus, Type 2
`Glucoæ Metabolism Dlsords16
`Melabolic Dissases
`Endocrlns Syôtem D¡ssases
`Glucâgon-Llke Peptldê l
`
`ClinicalTrlâls.gov processed thls rêcord on August 01, 20'11
`
`lncrêtlns
`Hormones
`Hormon€s, Hormone Subslitutes, and HomonsAntagonlsls
`Physiologicål Effscls of Drugs
`Pharmacologlc Actlons
`
`Cgalact-HelB.!€k
`U S. Nal¡onãl L¡brary of M€dic¡ne.
`L¡sl6r HìÌl Nel¡onâl &nter lor Âiom€di€ì Commúni.ål¡ons,
`U.s. Natioml lnsl¡uês or Hælth, U s Dopad$slofllgall[ÅlfunÊnsgfl¡$,
`!SA,wy, Capy¡sbt edwy. Àccessibility. fHlaüjtloþualian-Acl
`
`#m#
`
`MPI EXHIBIT 1013 PAGE 13
`
`MPI EXHIBIT 1013 PAGE 13
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1013, p. 13 of 41
`
`

`

`http://web.archive.orglwebl20I10625004803/https://clinicaltrials.gov/ct2lshow/NCT00696657
`
`MPI EXHIBIT 1013 PAGE 14
`
`MPI EXHIBIT 1013 PAGE 14
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1013, p. 14 of 41
`
`

`

`lllU[[[lllllmÍlifl0 26 capluCg
`28ocl?108,15Âp¡2021
`
`ClínícalTríals,gov
`
`A ¡.nlô. 6l thr U.8. Nilon¡l hdlM.r of HaJlh
`
`fõõl sEP
`
`AUG
`
`(Ð@a
`ntr
`
`2009
`2012
`Home Search Study-þplgs Glossary
`8a¡Ìch
`
`Full Toxt Vlcw
`
`Tabular View
`
`No Study-Res]llliesgled
`
`Relatêd Sludies
`
`A Randomised Gontrolled Clinical Tr¡al ¡n Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide
`
`This study has been completed.
`
`FirstReceívedonJune11,2008. LastUpdatsdonlVarchl6,20ll Historvofchanges
`
`Spon30r: Novo Nordisk
`
`lntormatlon provlded by: Novo Nordisk
`
`cl¡nicalliia¡s,gov ldsntlf ien NCT00696657
`
`Þ Purpose
`
`and the treâlment durât¡on wa6 12 we€ks.
`
`Cond¡t¡on
`
`O¡abetes Mellilus, Type 2
`
`Study
`Study
`
`lype:
`Deslgn:
`
`lntêrventlonal
`Allocatlonr Rândomized
`Endpoint Classificationì Sâfety/Ef¡cacy Study
`lnleryentlon Model: Parallel Asslgnment
`l\4askìng; Double Blind (Subject, lnvestigator)
`Prlmsry Purpose: Treâtment
`
`lnleruent¡on
`
`Drug: semaglutldè
`Drug: placebo
`Drug: llrãglutlde
`
`Phase
`
`Phase ll
`
`Off¡cialtitle;
`
`lnvestlgation of Safety and Efi¡cacy of F¡ve Doses of Semaglutide Versus Plácebo and Open-lab€l Liraglutlde, as Add on Thêrapy, in Subjects D¡agnosed With Type
`Cunently Treated With Meform¡n or Controlled With Diet and Exerc¡6e A 12 Weèk Mult¡-centre, Multl National, Double-bllnd. Plac€bo-controlled, Random¡sed, N¡ne
`Group, Dose Findlng Trial
`
`2 Diabetes
`Armed Parallel
`
`Rêsource links prov¡ded by NLM:
`
`Genetìcs Home Reference related topics: û124-related transient neonatal diab€tes mellitus
`
`MedlinêPlus relâtêd topics: Diabetes
`
`Drug lnformat¡on âva¡lable for; Liraglut¡de
`
`U.S. FDA Resources
`
`Further study dèta¡ls as providod by Novo Nordisk:
`
`Primâry Oulcome Mèasuresì
`. HbAlcfTlmeFramerafterl2weeksoftreatmentlIDesignatedassafelyissuê:No]
`
`Seændary Outcome Meâsures:
`. PercenlageofsubjectswithanadverseeventsITmeFrame:afterl2weeksoftreatment][Des¡gnatedassafetyissue:No]
`. Percentage of subjecls with hypoglycaemic episode I Time Frame: aftsr 1 2 wêeks of trsatment ] [ Dêsignated 8s saf€ty i6suê: No
`. change from basel¡ne in EcG I llme Fr€me: week 0, week l2 ] [ Designâted as safety issue: No ]
`. Change from bâsêline in vital signs (Pulse) [ Time Frame: week 0, weêk 12 ] [ Designated as safety lssue: No I
`. Change from baseline in vital signs (blood pressure) [
`'lime Frame: week 0. week 1 2 ] [ Designated as safety issuer No I
`. Chang€
`[ Tme Framêr w€ek 0, week 1 2 ] [ Designated as saiety issue: No ]
`lrom baseline in 6tandard safety laboratory param€ters (haematology)
`. Chånge from basel¡ne in standard safely laboratory parameters ( b¡ochem¡stry) [ Time Frame: wêek 0, week 1 2 ] [ Designat€d as safety ¡ssuê: No ]
`. Change from baset¡ne in standard safety laboratory parameters (urinålys¡s) [ Time Frame: week 0, week 1 2 ] [ Designated as safety issuer No ]
`. Change from basel¡ne in calcitonin I Time Frâme: week 0, week '1 2 ] [ Deslgnated as safety issue: No ]
`. Percenlage of subjects developing anli-semaglut¡de antibodies I Tjme Frame: afier 1 2 weeks ot treatment ] [ Designaled as safely lssue: No ]
`
`]
`
`Enrollment:
`415
`Study Stârt Date:
`June 2008
`Study Complet¡on Date: February 2009
`Pr¡mary Complotion Date: Februãry 2009 (F¡nal data colleclion date for pr¡mary outcome measure)
`
`Arms
`
`A: Experimental
`lnteruention: Drug: sêmaglutide
`
`B: Exp€r¡mental
`lnteruention: Drug: s€maglutide
`
`C: Experimental
`lnteruention: Drug: semaglutide
`
`Dr Exp€r¡mental
`lntervention: Drugì semaglulide
`
`Asslgned lnleruentlons
`
`Drug: semaglutide
`0.1 mg, once weekly, s.c. injection
`
`Drug: semaglut¡de
`0.2 mg, onc€ weekly, s.c.
`
`inject¡on
`
`Drug: semaglulide
`0.4 mg, once weekly, s.c. injection
`
`Drugi semaglut¡de
`0.8 mg, once weekly, s.c. injection
`
`MPI EXHIBIT 1013 PAGE 15
`
`MPI EXHIBIT 1013 PAGE 15
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1013, p. 15 of 41
`
`

`

`E: Experimental
`lntèrventlon: Drug; s€maglullde
`
`F: Experim€ntal
`lnteruentlon: Drug: semaglutide
`
`G1: Plâcebo Comparator
`lntsrusntion; Drug: placsbo
`
`G2: Plac€bo Comparalor
`Intsrvêntion: Drug: placsbo
`
`G3: Placebo Comparâtor
`lnteruentlon: Drug: placebo
`
`G4: Placebo Compârator
`lntèrventlon: Drug: placabo
`
`G5: Placèbo Compâralor
`lnteruention: Drug; placebo
`
`G6; Placebo Comparâtor
`lnterventlon: Drug: plâcebo
`
`H: Exper¡mentâl
`lnterv6ntlon: Drugr llraglutide
`
`l: Expèrlmental
`lnteruêntion: Drug: lkaglutide
`
`Orug: semsglutid€
`0.8 mg with titrâtlon, once weekly, s.c. ¡njectlon
`
`Drug: semaglutide
`1.6 mg w¡th tltrÊtion, once ws€kly, s.c. lnjection
`
`Drug: placebo
`0.1 mg, oncs wsekly, s.c. lnjectlon
`
`Drug: placebo
`0.2 mg, onc€ we€kly,
`
`s.c. inisction
`
`Drug: placabo
`0.4 mg, once weekly, s.o. ini€ctlon
`
`Drug; placebo
`0.8 rig with titration, once weekly, s,c. ¡njêction
`
`Drug: placebo
`0.8 mg w¡th titratlon, once w€€kly, s.c. injectlon
`
`Drug: placebo
`'L6 mg, once w6ekly, s.c. lnjectlon
`
`Drug: lkaglutide
`1.2 mg with tilrêtion, oncê dally, s.c. ¡njectlon
`
`Drug: llraglulide
`1.8 mg w¡th titrâtlon, once dally, s.c. inject¡on
`
`Þ etigioitiry
`Ages Eliglble for Sludy:
`18 Yeãrs ånd older
`Genders Eliglblê for Study: Both
`Accepts Healthy Voluntèèrs¡ No
`
`Crlterla
`lncluslon Crlterla:
`. l\4en and women-not-of-chlldbêaring potentlaf dlagnosed wlth type 2 dlabet€s for at
`leâst three month6
`. Stablê trsatm€nt regimen w¡th qlthsr metlorm¡n (at l€a6t 1500 m9) or di€t and exerclss alons for at lsast thrse months
`. HbAlc:7.0-10.0 0/o (both incluslve)
`. Body weight betlveen 60 kg ånd 1 l 0 kg
`Excluslon Crlterlâ:
`
`wlthln ths last thrês months
`. lmpâlred llvèr or kldney functlon
`. Prolllerâllve retlnopathy or maculopathy rcquldng âcul€ treatment
`. Clinically signllìcânt active cardlovâscular d¡sease and uncontrolled treated/untreâted hypertension
`. Racurrènt major hypoglyca6miâ or hypoglycaômic unåwar€n€ss
`. Present or planned use of any drug whlch could int€rfers with the glueose lsv€ls
`
`(e.9. syst€mic cortiæsterolds)
`
`Þ Gontacts and Locations
`Plêâse refêr lo lhis study by lts Clln¡câlIrlals.gov
`
`ldentitier: NCT00696657
`
`Locallons
`
`Austrla
`
`Wlèn, Austria, 1010
`
`Bulgar¡a
`
`F¡nland
`
`Ruòse, Bulgar¡å,7000
`
`Oulu, Flnland, 90029
`
`Form€r Sarbia and Montenegro
`Belgrade, Formêr Serbia and l\4ontenêgro, 11000
`
`France
`
`MONTPELLIER cedex 5, France, 34295
`
`Gêmany
`Pohlheim, Germany, 35415
`
`llungary
`
`lnd¡a
`
`Itaty
`
`Budapest, Hungary, H-1045
`
`Chennai, lndiâ,600020
`
`Chietl Sælo, ltaly, 66013
`
`Soüth Africâ
`Cape Town, W6stern Cape, South Afr¡ca, 7925
`
`Spa¡n
`
`Almeria, Spain,04001
`
`SwiÞerland
`Kûsnacht, SwlÞerland, 8700
`
`Turkey
`
`lstanbul, Turkey, M390
`
`MPI EXHIBIT 1013 PAGE 16
`
`MPI EXHIBIT 1013 PAGE 16
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1013, p. 16 of 41
`
`

`

`Unlt d Klngdom
`Bsxhlll-on-Sea, United Klngdom, TN39 4SP
`
`Sponsors and Collaboratori
`Novo Nordlsk
`
`lnvê3tloaûoE
`Study Dlroctor: Chri6llne B. Jenson, MD, PhD Novo Nord¡6k
`Þ More lnformåt¡on
`
`Addltional lnformatlon:
`Clinlcal Trlals at Novo Nordlsk gE
`
`No publlætlons provldèd
`
`Responsible Party:
`CllnlcalTrlal6.gov ldenlllier:
`Other Study lD Numbers:
`Study Flrst Receivsd:
`Last Updated:
`Heallh Authority:
`
`Novo Nordlsk A,/S ( Public Aces6s to clinical Trlale )
`NCT00696657 Hlstorv of Changes
`NN9535-1821, 2007-003956-1 2
`Jun€ 11,2008
`March 16,201f
`Austrla: Fedsral Mlnlstry for Hsalth and Women; Bulgârla: Bulgarian Orug Agêncyi Flnland: Flnnish Medlclnes Agôncy; France: Afssaps - French Hêâlth Products
`for Drugs ånd Medical Dovicss: Hungary: Nât¡onal lnstituts of Phsrmacyi lndla: Ministry of Heâlth; ltaly; Nâtional
`Saf€ty Ag€ncyi Germany: Fed€ral lnstllute
`Monliorlñg Cántre for Cllnical Trials - Mlnlstry of Health; Serbia: Medlc¡nê6 and Mediæl Dsvlcês Agency of Serbia; South Afrlæ: Medlcines Control Council:
`Spaln: Spanlsh Agancy of Msd¡cin€si Swltzêrland: Laws and standards; Turk€y: Ministry of Heallh; Unlt€d Klngdom: Medlcinss and H€althcar€ Products
`Rsgulstory Agency
`
`Addltlonål rêlevant MgSH torms:
`Olabetes Mellitus
`Diâbetês Mellitus, Typ€ 2
`Glucose MetabollÊm Disordsrs
`Mstabolic Dlseases
`Endocrine System Diseases
`I
`Gluægon-Llke P6plld€
`
`CllnlcålTrlals.gov procesÊed lhls record on June 24,2011
`
`lncretlns
`Hormones
`Homonês, Hormone Substltut€s, and Hormone Anlagon¡sts
`Phys¡ologlcal Efecls of Drugs
`Pharmaæloglc Actlong
`
`Contåct H6lÈ[¡9Sl
`Listsr H¡ll National &nler fo. BiomediÉl Commun¡ølions, Ú S. Nâl¡onal LibBry of M€dìc¡ne.
`tl s Nâlional ln6ììlutes ôl Hællh, U.S. D€p¡dmlllt-Hsallb.ll¡ma¡]$flis,
`lsÀsq. Capy¡Sbt. PdWy. Acæssibility, Fßdom ol lnfornralion Ad
`
`#m',k
`
`MPI EXHIBIT 1013 PAGE 17
`
`MPI EXHIBIT 1013 PAGE 17
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1013, p. 17 of 41
`
`

`

`http://web.archive.orglweb1200909012123O3/https://clinicaltrials.gov/ct2lshow/NCT00696657
`
`MPI EXHIBIT 1013 PAGE 18
`
`MPI EXHIBIT 1013 PAGE 18
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1013, p. 18 of 41
`
`

`

`Tõ;-l MAY
`
`JUN
`
`(Doa
`Etr
`,'alrìíl
`2011
`Sêârch Study_trgpEs Glossary
`Sarrch
`
`lllrüll[llfllilllil0 26 caplllgg
`26 &l 2408. 15^pr 2021
`
`ClínícølTriøls,gov
`
`ollha U.S. Nllonal hrl¡ll¡.¡ ol fiollh
`
`^r.ruiaa
`
`Fu¡l T.xt V¡cw
`
`Tâbular Viêw
`
`No study-BssslgPegled
`
`Related Slud¡es
`
`A Trlal ¡n Type 2 D¡abetes Comparing NN9535 to Placebo and L¡raglutide
`
`Th¡s study has been completed.
`
`Flrst Rêcelved: June'11, 2008 Last Updated: Fsbruary 6, 2009 Historv of Changes
`
`SponEofed by: Novo Nordisk
`
`lntormatlon providêd by: Novo Nordisk
`
`Clin¡callilals.gov ldentif ier: NCTo0696657
`
`Þ Purpose
`
`trêatm€nt duration
`
`is 12 weaks.
`
`CÕnd¡t¡on
`
`Dlabetes Mellltus, Type 2
`
`lnteruent¡on
`
`Drug: NN9535
`Drug: plaæbo
`Drug: Ilraglutide
`
`Phase
`
`Phase ll
`
`StudyType: lnteruentional
`Study Design: Treatment, Random¡zed, Double Bl¡nd (Subject, lnvestigator), Placebo Control, Parâllel Ass¡gnment, Safety/Efficacy Study
`Officiat Titler A Dose Finding Tr¡al Establlshing Efficacy and Safety of NN9535 ln Comparison With Placebo and Lirâglutide ¡n Type 2 D¡abetes
`
`R€source links provided by NLM:
`
`MedlinePlus related topicsr Qþþqlcs
`Þrug lnformat¡o