{"id":"https://openalex.org/W4281665347","doi":"https://doi.org/10.2337/db22-392-p","title":"392-P: Phase 1, Randomized, Controlled Trial of GFB-024, a Once-Monthly CB1 Inverse Agonist, in Healthy Overweight and Obese Participants and in Participants with Type 2 Diabetes Mellitus","display_name":"392-P: Phase 1, Randomized, Controlled Trial of GFB-024, a Once-Monthly CB1 Inverse Agonist, in Healthy Overweight and Obese Participants and in Participants with Type 2 Diabetes Mellitus","publication_year":2022,"publication_date":"2022-05-31","ids":{"openalex":"https://openalex.org/W4281665347","doi":"https://doi.org/10.2337/db22-392-p"},"language":"en","primary_location":{"id":"doi:10.2337/db22-392-p","doi":"https://doi.org/10.2337/db22-392-p","is_oa":false,"landing_page_url":"https://doi.org/10.2337/db22-392-p","pdf_url":null,"source":{"id":"https://openalex.org/S129060628","display_name":"Diabetes","issn_l":"0012-1797","issn":["0012-1797","1939-327X"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-3","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320274","host_organization_name":"American Diabetes Association","host_organization_lineage":["https://openalex.org/P4310320274"],"host_organization_lineage_names":["American Diabetes Association"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Diabetes","raw_type":"journal-article"},"volume":null,"type":"article","indexed_in":["crossref"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5111818132","display_name":"Gregory A. Gaich","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"GREGORY GAICH","raw_affiliation_strings":["West Des Moines, IA, Cambridge, MA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"West Des Moines, IA, Cambridge, MA","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5087903486","display_name":"Sanela Bilic","orcid":"https://orcid.org/0009-0007-0181-7134","observed_orcids":["https://orcid.org/0009-0007-0181-7134"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"SANELA BILIC","raw_affiliation_strings":["West Des Moines, IA, Cambridge, MA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"West Des Moines, IA, Cambridge, MA","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5005918045","display_name":"Yossi Dagon","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"YOSSI DAGON","raw_affiliation_strings":["West Des Moines, IA, Cambridge, MA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"West Des Moines, IA, Cambridge, MA","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5026851541","display_name":"Thomas A. Gustafson","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"THOMAS GUSTAFSON","raw_affiliation_strings":["West Des Moines, IA, Cambridge, MA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"West Des Moines, IA, Cambridge, MA","institution_ids":[]}]},{"author_position":"middle","author":{"id":null,"display_name":"JOHN LAWLER","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"JOHN LAWLER","raw_affiliation_strings":["West Des Moines, IA, Cambridge, MA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"West Des Moines, IA, Cambridge, MA","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5016971508","display_name":"LESLIE JOHNSON","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"LESLIE JOHNSON","raw_affiliation_strings":["West Des Moines, IA, Cambridge, MA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"West Des Moines, IA, Cambridge, MA","institution_ids":[]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5079490856","display_name":"Lori Rudolph-Owen","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"LORI RUDOLPH-OWEN","raw_affiliation_strings":["West Des Moines, IA, Cambridge, MA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"West Des Moines, IA, Cambridge, MA","institution_ids":[]}]}],"institutions":[],"countries_distinct_count":0,"institutions_distinct_count":0,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":0.289,"has_fulltext":false,"cited_by_count":2,"citation_normalized_percentile":{"value":0.47490662,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":88,"max":94},"biblio":{"volume":"71","issue":"Supplement_1","first_page":null,"last_page":null},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10414","display_name":"Cannabis and Cannabinoid Research","score":0.8115000128746033,"subfield":{"id":"https://openalex.org/subfields/2736","display_name":"Pharmacology (medical)"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T10414","display_name":"Cannabis and Cannabinoid Research","score":0.8115000128746033,"subfield":{"id":"https://openalex.org/subfields/2736","display_name":"Pharmacology (medical)"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10408","display_name":"Chronic Kidney Disease and Diabetes","score":0.11079999804496765,"subfield":{"id":"https://openalex.org/subfields/2727","display_name":"Nephrology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T11029","display_name":"Renal Diseases and Glomerulopathies","score":0.010400000028312206,"subfield":{"id":"https://openalex.org/subfields/2727","display_name":"Nephrology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/cannabinoid-1-receptor","display_name":"cannabinoid 1 receptor","score":0.949999988079071},{"id":"https://openalex.org/keywords/diabetic-nephropathy","display_name":"diabetic nephropathy","score":0.890999972820282},{"id":"https://openalex.org/keywords/podocytes","display_name":"podocytes","score":0.8050000071525574},{"id":"https://openalex.org/keywords/type-2-diabetes","display_name":"type 2 diabetes","score":0.8889999985694885},{"id":"https://openalex.org/keywords/obesity","display_name":"obesity","score":0.9509999752044678},{"id":"https://openalex.org/keywords/pharmacokinetics","display_name":"pharmacokinetics","score":0.7139999866485596},{"id":"https://openalex.org/keywords/safety-and-tolerability","display_name":"safety and tolerability","score":0.8830000162124634},{"id":"https://openalex.org/keywords/immunogenicity","display_name":"immunogenicity","score":0.7099999785423279},{"id":"https://openalex.org/keywords/humanized-antibody","display_name":"humanized monoclonal antibody","score":0.8379999995231628},{"id":"https://openalex.org/keywords/albuminuria","display_name":"albuminuria","score":0.7720000147819519},{"id":"https://openalex.org/keywords/renal-fibrosis","display_name":"renal fibrosis","score":0.75},{"id":"https://openalex.org/keywords/single-ascending-dose","display_name":"single ascending dose","score":0.7200000286102295},{"id":"https://openalex.org/keywords/once-monthly-dosing","display_name":"once-monthly dosing","score":0.9419999718666077},{"id":"https://openalex.org/keywords/podocyte-injury","display_name":"podocyte injury","score":0.42899999022483826}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.7985476851463318},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.5989909172058105},{"id":"https://openalex.org/C134018914","wikidata":"https://www.wikidata.org/wiki/Q162606","display_name":"Endocrinology","level":1,"score":0.5604340434074402},{"id":"https://openalex.org/C555293320","wikidata":"https://www.wikidata.org/wiki/Q12206","display_name":"Diabetes mellitus","level":2,"score":0.5528547167778015},{"id":"https://openalex.org/C148001335","wikidata":"https://www.wikidata.org/wiki/Q421237","display_name":"Cannabinoid receptor","level":4,"score":0.5484883189201355},{"id":"https://openalex.org/C2776174234","wikidata":"https://www.wikidata.org/wiki/Q974792","display_name":"Albuminuria","level":3,"score":0.43801647424697876},{"id":"https://openalex.org/C2778938600","wikidata":"https://www.wikidata.org/wiki/Q389934","display_name":"Agonist","level":3,"score":0.3762676417827606},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.35406285524368286},{"id":"https://openalex.org/C170493617","wikidata":"https://www.wikidata.org/wiki/Q208467","display_name":"Receptor","level":2,"score":0.21455013751983643}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.2337/db22-392-p","doi":"https://doi.org/10.2337/db22-392-p","is_oa":false,"landing_page_url":"https://doi.org/10.2337/db22-392-p","pdf_url":null,"source":{"id":"https://openalex.org/S129060628","display_name":"Diabetes","issn_l":"0012-1797","issn":["0012-1797","1939-327X"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-3","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320274","host_organization_name":"American Diabetes Association","host_organization_lineage":["https://openalex.org/P4310320274"],"host_organization_lineage_names":["American Diabetes Association"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Diabetes","raw_type":"journal-article"}],"best_oa_location":null,"sustainable_development_goals":[{"display_name":"Good health and well-being","score":1.0,"id":"https://metadata.un.org/sdg/3"}],"study_designs":[{"display_name":"Clinical Trial","id":"https://openalex.org/study-designs/clinical-trial"}],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W4308134815","https://openalex.org/W4360962054","https://openalex.org/W1971955583","https://openalex.org/W2768055940","https://openalex.org/W2096748864","https://openalex.org/W4229041238","https://openalex.org/W2028879462","https://openalex.org/W2143613076","https://openalex.org/W2133646146","https://openalex.org/W2605268812"],"abstract_inverted_index":{"Evidence":[0],"from":[1,116,213],"nonclinical":[2],"studies":[3],"suggests":[4],"a":[5,85,92,109,124,210,263],"role":[6],"of":[7,14,32,62,69,145,162,252],"cannabinoid-1":[8],"receptor":[9],"(CB1)":[10],"in":[11,24,29,71,100,118,147,184,194,226],"the":[12,103,137,185,188,205,227,237],"development":[13],"diabetic":[15],"nephropathy":[16],"(DN)":[17],".":[18,38],"Kidney":[19],"CB1":[20,41,70,104],"expression":[21],"is":[22,84,108],"upregulated":[23],"podocytes":[25,72,99,115],"and":[26,34,54,56,80,143,151,174,246,267],"tubular":[27,75,81],"cells":[28,76],"murine":[30],"models":[31,61],"obesity":[33],"diabetes":[35],"mellitus":[36],"(DM)":[37],"Inhibition":[39],"by":[40],"inverse":[42,94],"agonists":[43],"has":[44],"been":[45],"shown":[46,65],"to":[47,113,165,254],"ameliorate":[48],"diabetes-induced":[49],"albuminuria,":[50],"inhibit":[51],"kidney":[52],"fibrosis":[53],"inflammation,":[55],"prevent":[57],"podocyte":[58],"dysfunction.":[59,82],"Mouse":[60],"DM":[63],"have":[64],"that":[66,96],"genetic":[67],"deletion":[68],"or":[73],"proximal":[74],"protects":[77,97],"against":[78],"glomerular":[79],"GFB-024":[83,107,146,170,243],"recombinant":[86],"humanized":[87],"monoclonal":[88],"antibody":[89],"functioning":[90],"as":[91],"CB1-specific":[93],"agonist":[95],"human":[98],"vitro.":[101],"Targeting":[102],"pathway":[105],"with":[106,120,201,209,223,271],"potentially":[110,260],"novel":[111],"approach":[112],"protecting":[114],"injury":[117],"patients":[119],"CB1-associated":[121],"DN.":[122],"In":[123,241],"phase":[125],"1,":[126],"randomized,":[127],"double-blind,":[128],"placebo-controlled":[129],"single":[130,160,250],"ascending":[131],"dose":[132,239],"(SAD)":[133],"trial,":[134],"we":[135],"evaluated":[136],"safety,":[138],"tolerability,":[139],"pharmacokinetics":[140],"(PK)":[141],",":[142],"immunogenicity":[144],"38":[148],"healthy":[149],"overweight":[150],"obese":[152],"(BMI":[153],"25":[154],"-":[155],"40":[156],"kg/m2)":[157],"participants,":[158],"receiving":[159],"doses":[161,251],"5":[163],"mg":[164,167],"300":[166,255],"administered":[168],"subcutaneously.":[169],"was":[171,199,219,244],"well":[172,247],"tolerated,":[173],"there":[175],"were":[176],"no":[177],"dose-limiting":[178],"adverse":[179],"effects.":[180],"PK":[181,257],"exposures":[182,224],"achieved":[183],"trial":[186],"exceeded":[187],"estimated":[189,228],"efficacious":[190,229,261],"exposure,":[191,262],"based":[192],"on":[193],"vitro":[195],"activity":[196],"assays.":[197],"Absorption":[198],"prolonged":[200,264],"flat":[202],"exposure":[203],"over":[204],"first":[206],"7":[207],"days,":[208,222],"Tmax":[211],"ranging":[212],"approximately":[214,220],"4-7":[215],"days.":[216],"Elimination":[217],"half-life":[218,269],"12-13":[221],"remaining":[225],"range":[230],"at":[231],"28":[232],"days":[233],"for":[234],"all":[235],"but":[236],"lowest":[238],"tested.":[240],"summary,":[242],"safe":[245],"tolerated":[248],"following":[249],"up":[253],"mg.":[256],"analysis":[258],"demonstrated":[259],"absorption":[265],"phase,":[266],"elimination":[268],"compatible":[270],"once-monthly":[272],"dosing.":[273],"Disclosure":[274],"G.Gaich:":[275],"Consultant;":[276,285],"89":[277],"bio,":[278],"Inc.,":[279,298],"Employee;":[280,290,295,303,308,313],"Goldfinch":[281,286,291,296,304,309,314],"Bio,":[282,287,292,297,305,310,315],"Inc.":[283,288,293,301,306,311,316],"S.Bilic:":[284],"Y.Dagon:":[289],"T.Gustafson:":[294],"Janssen":[299],"Pharmaceuticals,":[300],"J.Lawler:":[302],"L.Johnson:":[307],"L.Rudolph-owen:":[312]},"counts_by_year":[{"year":2025,"cited_by_count":1},{"year":2023,"cited_by_count":1}],"updated_date":"2026-11-04T10:54:05.112534","created_date":"2022-06-13T00:00:00"}