[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07310901":3,"trial-entities:NCT07310901":233,"trial-summary:NCT07310901":236},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":50,"secondary_outcomes":68,"sex":78,"minimum_age":79,"maximum_age":80,"healthy_volunteers":15,"eligibility_criteria":81,"std_ages":107,"locations":110,"central_contacts":226,"overall_officials":227,"references":231,"see_also_links":232},"NCT07310901","CRB-913-02","A 2-part, Phase 1b Clinical Study Designed to Evaluate the Safety, PK, and Efficacy of CRB-913 in Participants With Obesity","A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Dose-Range Finding Study of the Efficacy, Safety, and Pharmacokinetics of CRB-913 in Participants With Obesity With a Single Cohort Open-label Exploratory Pharmacokinetic Lead-In","ACTIVE_NOT_RECRUITING","2026-07-31","2026-05","2026-05-29","2025-12-04","Corbus Pharmaceuticals Inc.","INDUSTRY",false,"This study will assess the safety of the investigational drug CRB-913 and how it is processed in the body.\n\nThe study has two parts: Part 1 will measure drug levels in healthy adults after taking CRB-913 tablets, and Part 2 will compare three doses of CRB-913 with placebo to evaluate safety, effects on body weight, and drug levels in the blood.\n\nPart 2 is blinded, meaning participants, study doctors, and the sponsor will not know which treatment is given.\n\nParticipants in Part 2 will take study treatment for 12 weeks and will be followed for 28 days after treatment ends.","CRB-913 is a novel cannabinoid receptor type 1 (CB1) inverse agonist (CB1-IA) that is being developed for once-daily treatment of obesity.\n\nThis study will look at how the investigational drug CRB-913 behaves in the body and how it affects body weight.\n\nThe study has two parts:\n\nPart 1 will include healthy adult participants. They will receive CRB-913 in tablet form. Researchers will measure how much of the drug enters the bloodstream and how long it stays there.\n\nPart 2 will include participants who will receive one of three different doses of CRB-913 or a placebo (a tablet with no active drug). This part of the study will look at the safety of CRB-913 and its effects on body weight. Researchers will also measure the amount of CRB-913 in the blood.\n\nPart 2 is blinded, which means that participants, study doctors, and the study sponsor will not know who is receiving CRB-913 or placebo.\n\nAll participants in Part 2 will take their assigned study tablets for 12 weeks, followed by a 28-day follow-up period after treatment ends.\n\nThe information collected in this study will help determine whether CRB-913 is safe, how the body processes it, and whether it may help with weight-related outcomes.",[19],"Obese But Otherwise Healthy Participants",[21,22,23,24,25,26,27,28],"Obesity","Body Weight","Nutritional and Metabolic Diseases","Metabolic Diseases","Endocrine System Diseases","Overweight","Nutrition Disorders","Cannabinoid-1 receptor inverse agonist","INTERVENTIONAL","TREATMENT",[32],"PHASE1",{"count":34,"type":35},252,"ESTIMATED",[37,46],{"type":38,"name":39,"description":40,"armGroupLabels":41},"DRUG","CRB-913","Administered QD",[42,43,44,45],"Part 1: PK Lead-in","Part 2: CRB-913 High Dose","Part 2: CRB-913 Medium Dose","Part 2: CRB-913 low dose",{"type":38,"name":47,"description":40,"armGroupLabels":48},"Placebo",[49],"Part 2: Placebo",[51,55,58,61,65],{"measure":52,"description":53,"timeFrame":54},"Part 1: To evaluate the PK of a single dose of CRB-913 - Cmax","Maximum plasma concentration (Cmax)","0 to 48 hours",{"measure":56,"description":57,"timeFrame":54},"Part 1: To evaluate the PK of a single dose of CRB-913 - Tmax","Time to maximum plasma concentration (Tmax)",{"measure":59,"description":60,"timeFrame":54},"Part 1: To evaluate the PK of a single dose of CRB-913 - T1\u002F2","Terminal elimination half-life (T1\u002F2)",{"measure":62,"description":63,"timeFrame":64},"Part 2: To evaluate the safety of CRB-913 - TEAE","Incidence and severity of treatment emergent adverse events","Day 1 to 28 days post final dose",{"measure":66,"description":67,"timeFrame":64},"Part 2: To evaluate the safety of CRB-913 - AESI","Incidence of adverse events of special interest",[69,71,74,76],{"measure":70,"description":63,"timeFrame":64},"Part 1: To evaluate the safety of a single dose of CRB-913 - TEAE",{"measure":72,"description":73,"timeFrame":64},"Part 2: To evaluate the effect of CRB-913 on weight","Mean change in absolute body weight from baseline to End of Treatment (EOT) compared to placebo",{"measure":75,"description":53,"timeFrame":64},"Part 2: To evaluate the PK of CRB-913 - Cmax",{"measure":77,"description":57,"timeFrame":64},"Part 2: To evaluate the PK of CRB-913 - Tmax","ALL","18 Years","75 Years",{"inclusion":82,"exclusion":85,"raw_text":106},[83,84],"Part 1: Participants with BMI 18.0-25.0 kg\u002Fm²","Part 2: Obese participants with BMI ≥30 kg\u002Fm²",[86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105],"Significant liver disease or moderate-severe hepatic impairment","History of seizures, epilepsy, or intracranial surgery","Diabetes mellitus (Type 1 or Type 2), except gestational","Bariatric surgery or \\>5 kg weight change in past 3 months","Recent use (within 3 months) of GLP-1 agonists or other weight-loss medications","Major depression within 2 years.","Any history of suicidal ideation\u002Fattempt","Severe psychiatric disorders (e.g., schizophrenia, bipolar disorder)","Elevated screening scores: PHQ-9 \\>4, GAD-7 \\>4, or positive C-SSRS Items 1-2","Active or recent (within 5 years) malignancy (exceptions: in situ and fully resected nonmelanoma skin cancer)","Abnormal thyroid function: TSH \\>6 mIU\u002FL unless stable on replacement therapy","QTc \\>470 msec (females) or \\>450 msec (males) or history of long QT syndrome","Use of systemic corticosteroids or unstable chronic medications affecting BP, lipids, or glucose","Use of CYP3A4 substrates or strong P-gp substrates\u002Finhibitors","Investigational drug use within 28 days","Prior exposure to CRB-913 or other CB1 inverse agonists\u002Fantagonists","Substance abuse history","Pregnancy, breastfeeding, or unwillingness to use highly effective contraception","Positive drug or alcohol screen","Any condition that, in the investigator's judgment, makes participation unsafe or non-feasible","Inclusion Criteria:\n\n* Part 1: Participants with BMI 18.0-25.0 kg\u002Fm²\n* Part 2: Obese participants with BMI ≥30 kg\u002Fm²\n\nExclusion Criteria:\n\n* Significant liver disease or moderate-severe hepatic impairment\n* History of seizures, epilepsy, or intracranial surgery\n* Diabetes mellitus (Type 1 or Type 2), except gestational\n* Bariatric surgery or \\>5 kg weight change in past 3 months\n* Recent use (within 3 months) of GLP-1 agonists or other weight-loss medications\n* Major depression within 2 years.\n* Any history of suicidal ideation\u002Fattempt\n* Severe psychiatric disorders (e.g., schizophrenia, bipolar disorder)\n* Elevated screening scores: PHQ-9 \\>4, GAD-7 \\>4, or positive C-SSRS Items 1-2\n* Active or recent (within 5 years) malignancy (exceptions: in situ and fully resected nonmelanoma skin cancer)\n* Abnormal thyroid function: TSH \\>6 mIU\u002FL unless stable on replacement therapy\n* QTc \\>470 msec (females) or \\>450 msec (males) or history of long QT syndrome\n* Use of systemic corticosteroids or unstable chronic medications affecting BP, lipids, or glucose\n* Use of CYP3A4 substrates or strong P-gp substrates\u002Finhibitors\n* Investigational drug use within 28 days\n* Prior exposure to CRB-913 or other CB1 inverse agonists\u002Fantagonists\n* Substance abuse history\n* Pregnancy, breastfeeding, or unwillingness to use highly effective contraception\n* Positive drug or alcohol screen\n* Any condition that, in the investigator's judgment, makes participation unsafe or non-feasible",[108,109],"ADULT","OLDER_ADULT",[111,120,128,136,144,151,158,166,174,182,189,197,205,212,219],{"facility":112,"city":113,"state":114,"zip":115,"country":116,"geoPoint":117},"Central Alabama Research","Birmingham","Alabama","35209","United States",{"lat":118,"lon":119},33.52066,-86.80249,{"facility":121,"city":122,"state":123,"zip":124,"country":116,"geoPoint":125},"Arizona Clinical Trials","Chandler","Arizona","85225",{"lat":126,"lon":127},33.30616,-111.84125,{"facility":129,"city":130,"state":131,"zip":132,"country":116,"geoPoint":133},"Prospective Research Innovations","Rancho Cucamonga","California","91730",{"lat":134,"lon":135},34.1064,-117.59311,{"facility":137,"city":138,"state":139,"zip":140,"country":116,"geoPoint":141},"Accel Research Sites","DeLand","Florida","32720",{"lat":142,"lon":143},29.02832,-81.30312,{"facility":145,"city":146,"state":139,"zip":147,"country":116,"geoPoint":148},"Tampa Bay Medical Research","Largo","33761",{"lat":149,"lon":150},27.90979,-82.78842,{"facility":152,"city":153,"state":139,"zip":154,"country":116,"geoPoint":155},"Quotient Sciences","Miami","33126",{"lat":156,"lon":157},25.77427,-80.19366,{"facility":159,"city":160,"state":161,"zip":162,"country":116,"geoPoint":163},"Louisville Metabolic and Atherosclerosis Research Center","Louisville","Kentucky","40213",{"lat":164,"lon":165},38.25424,-85.75941,{"facility":167,"city":168,"state":169,"zip":170,"country":116,"geoPoint":171},"Alliance Clinical","Las Vegas","Nevada","89109",{"lat":172,"lon":173},36.17497,-115.13722,{"facility":175,"city":176,"state":177,"zip":178,"country":116,"geoPoint":179},"Neurobehavioral Research","Cedarhurst","New York","11516",{"lat":180,"lon":181},40.62288,-73.7243,{"facility":183,"city":184,"state":177,"zip":185,"country":116,"geoPoint":186},"Rochester Clinical Research","Rochester","14609",{"lat":187,"lon":188},43.15478,-77.61556,{"facility":190,"city":191,"state":192,"zip":193,"country":116,"geoPoint":194},"Lucas Research","Morehead City","North Carolina","28557",{"lat":195,"lon":196},34.72294,-76.72604,{"facility":198,"city":199,"state":200,"zip":201,"country":116,"geoPoint":202},"Medpace Clinical Pharmacology","Cincinnati","Ohio","45227",{"lat":203,"lon":204},39.12711,-84.51439,{"facility":206,"city":207,"state":200,"zip":208,"country":116,"geoPoint":209},"Velocity Clinical Research","Cleveland","44122",{"lat":210,"lon":211},41.4995,-81.69541,{"facility":206,"city":213,"state":214,"zip":215,"country":116,"geoPoint":216},"Dallas","Texas","75230",{"lat":217,"lon":218},32.78306,-96.80667,{"facility":220,"city":221,"state":214,"zip":222,"country":116,"geoPoint":223},"Flourish Research","San Antonio","78229",{"lat":224,"lon":225},29.42412,-98.49363,[],[228],{"name":229,"affiliation":198,"role":230},"Leela Vrishabhendra, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":234,"biomarkers":235},[21,26],[],{"nct_id":4,"found":15,"summary":237,"prompt_version":237},null]