[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654719":3},{"organization":4,"outcomesModule":7,"designInfo":69,"detailedDescription":11,"studyPopulation":11,"armGroups":81,"interventions":91,"overallOfficials":11,"centralContacts":101,"locations":107,"responsibleParty":124,"collaborators":11,"id":127,"slug":128,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":11,"eligibilityCriteria":133,"healthyVolunteers":134,"sex":135,"minAge":136,"maxAge":137,"enrollmentInfo":138,"targetDuration":11,"studyType":141,"phases":142,"briefSummary":144,"conditions":145,"keywords":149,"overallStatus":153,"whyStopped":11,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"fullName":5,"class":6},"Henan University of Science and Technology","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":32,"otherOutcomes":11},[9,13,15,17,19,21,24,26,28,30],{"measure":10,"description":11,"timeFrame":12},"Number of Participants With Adverse Events (Part A)",null,"Through study completion, an average of 29 days.",{"measure":14,"description":11,"timeFrame":12},"Number of Participants With Abnormal Physical Examination Findings (Part A)",{"measure":16,"description":11,"timeFrame":12},"Number of Participants With Clinically Significant Abnormal Vital Signs (Part A)",{"measure":18,"description":11,"timeFrame":12},"Number of Participants With Clinically Significant Abnormal Laboratory Tests (Part A)",{"measure":20,"description":11,"timeFrame":12},"Number of Participants With Clinically Significant Abnormal Twelve-Lead Electrocardiogram Readings (Part A)",{"measure":22,"description":11,"timeFrame":23},"Number of Participants With Adverse Events (Part B)","Through study completion, an average of 57 days.",{"measure":25,"description":11,"timeFrame":23},"Number of Participants With Abnormal Physical Examination Findings (Part B)",{"measure":27,"description":11,"timeFrame":23},"Number of Participants With Clinically Significant Abnormal Vital Signs (Part B)",{"measure":29,"description":11,"timeFrame":23},"Number of Participants With Clinically Significant Abnormal Laboratory Tests (Part B)",{"measure":31,"description":11,"timeFrame":23},"Number of Participants With Clinically Significant Abnormal Twelve-Lead Electrocardiogram Readings (Part B)",[33,35,37,39,41,43,45,47,49,51,53,55,57,59,61,63,65,67],{"measure":34,"description":11,"timeFrame":12},"Area under the blood concentration-time curve (AUC) (Part A)",{"measure":36,"description":11,"timeFrame":12},"Peak Plasma Concentration (Cmax) (Part A)",{"measure":38,"description":11,"timeFrame":12},"Time to Reach Peak Plasma Concentration (Tmax) (Part A)",{"measure":40,"description":11,"timeFrame":12},"Apparent Clearance (CL\u002FF) (Part A)",{"measure":42,"description":11,"timeFrame":12},"Apparent Volume of Distribution (Vz\u002FF) (Part A)",{"measure":44,"description":11,"timeFrame":12},"Terminal Half-Life (T1\u002F2) (Part A)",{"measure":46,"description":11,"timeFrame":23},"Area Under the Plasma Concentration-Time Curve (AUC) (Part B)",{"measure":48,"description":11,"timeFrame":23},"Peak Plasma Concentration (Cmax) (Part B)",{"measure":50,"description":11,"timeFrame":23},"Time to Reach Peak Plasma Concentration (Tmax) (Part B)",{"measure":52,"description":11,"timeFrame":23},"Apparent Clearance (CL\u002FF) (Part B)",{"measure":54,"description":11,"timeFrame":23},"Apparent Volume of Distribution (Vz\u002FF) (Part B)",{"measure":56,"description":11,"timeFrame":23},"Terminal Half-Life (T1\u002F2) (Part B)",{"measure":58,"description":11,"timeFrame":23},"Changes in body weight from baseline (Part B)",{"measure":60,"description":11,"timeFrame":23},"Percentage change in body weight from baseline (Part B)",{"measure":62,"description":11,"timeFrame":23},"Percentage change in waist circumference from baseline (Part B)",{"measure":64,"description":11,"timeFrame":23},"Percentage change in body mass index (BMI) from baseline (Part B)",{"measure":66,"description":11,"timeFrame":23},"Body Mass Index (BMI) change from baseline (Part B)",{"measure":68,"description":11,"timeFrame":23},"Changes in waist circumference from baseline (Part B)",{"allocation":70,"interventionModel":71,"interventionModelDescription":72,"primaryPurpose":73,"observationalModel":11,"timePerspective":11,"maskingInfo":74},"RANDOMIZED","SEQUENTIAL","Sequential group-assignment design, including single ascending dose (SAD) phase and multiple ascending dose (MAD) phase. Cohort A0 receives IBI3042 in a non-randomized manner. Participants in other cohorts are randomized to receive IBI3042 or matching placebo.","TREATMENT",{"masking":75,"maskingDescription":76,"whoMasked":77},"TRIPLE","Participants, care providers and outcome assessors are blinded to treatment assignment. Most investigators remain blinded. Selected unblinded investigators (dose-escalation committee members) have access to treatment allocation for safety evaluation and dose-escalation decision-making.",[78,79,80],"PARTICIPANT","CARE_PROVIDER","OUTCOMES_ASSESSOR",[82,87],{"label":83,"type":84,"description":11,"interventionNames":85},"IBI3042 treatment Group","EXPERIMENTAL",[86],"Drug: IBI3042",{"label":88,"type":84,"description":11,"interventionNames":89},"Placebo Control Group",[90],"Drug: Placebo",[92,97],{"type":93,"name":94,"description":95,"armGroupLabels":96,"otherNames":11},"DRUG","IBI3042","IBI3042 is an investigational oral drug administered as single or multiple doses according to the study protocol.",[83],{"type":93,"name":98,"description":99,"armGroupLabels":100,"otherNames":11},"Placebo","Matching oral placebo is administered as single or multiple doses according to the study protocol.",[88],[102],{"name":103,"role":104,"phone":105,"phoneExt":11,"email":106},"Hongwei Jiang","CONTACT","+86-0379-64830815","jianghw@haust.edu.cn",[108],{"facility":109,"status":11,"city":110,"state":111,"zip":11,"country":112,"countryCode":113,"cosmosGeoPoint":114,"geoPoint":119,"contacts":120},"The First Affiliated Hospital of Henan University of Science and Technology","Luoyang","Hennan","China","CN",{"type":115,"coordinates":116},"Point",[117,118],112.43684,34.67345,{"lat":118,"lon":117},[121],{"name":122,"role":104,"phone":105,"phoneExt":11,"email":123},"Caie Wang","245454618@qq.com",{"type":125,"investigatorFullName":103,"investigatorTitle":126,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Chief Physician","100654719","phase-1-an-exploratory-study-of-single-dose-and-multiple-doses-ibi3042-in-healthy-overweight-or-obese-participants-100654719",false,"NCT07802899","An Exploratory Study of Single-Dose and Multiple-Doses IBI3042 in Healthy, Overweight, or Obese Participants","An Exploratory Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Dose IBI3042 in Healthy or Overweight Participants and Multiple-Dose IBI3042 in Overweight or Obese Participants","Inclusion Criteria:\n\n* Aged 18 to 55 years, inclusive.\n* For Part A: BMI ≥20 and\\\u003C28 kg\u002Fm\\^2 and body weight ≥50 kg.\n* For Part B: BMI ≥24 and ≤40 kg\u002Fm\\^2, with stable body weight during the 3 months prior to screening.\n* Female participants of childbearing potential and male participants with female partners of childbearing potential must agree to use highly effective contraception during the study and for 90 days after the last dose.\n* Able and willing to comply with study procedures and voluntarily provide written informed consent.\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to any component of the study drug or to GLP-1 receptor agonists.\n* History of diabetes or abnormal glycemic parameters at screening.\n* Personal or family history of thyroid C-cell carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN 2A or 2B), or calcitonin ≥20 ng\u002FL at screening.\n* History of acute or chronic pancreatitis, or clinically significant pancreatic enzyme elevation at screening.\n* Use of medications that may significantly affect gastrointestinal motility, appetite, or drug absorption within 3 months prior to screening.\n* Clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic disease that may increase study-related risk or interfere with study assessments.\n* Clinically significant abnormalities in physical examination or laboratory tests at screening.\n* History of malignancy within 5 years, except for basal cell or squamous cell skin cancer.\n* Use of prescription or over-the-counter medications, dietary supplements, or herbal medicines within 2 weeks or 5 half-lives prior to screening, except as permitted by the protocol.\n* Participation in another drug or medical device clinical study within 3 months prior to screening or within 5 half-lives of the investigational drug, as applicable.\n* Any other condition that, in the investigator's opinion, makes the participant unsuitable for participation in the study.",true,"ALL","18 Years","55 Years",{"count":139,"type":140},94,"ESTIMATED","INTERVENTIONAL",[143],"PHASE1","The goal of this study is to learn about the safety and tolerability of IBI3042, an investigational oral drug that activates the glucagon-like peptide-1 (GLP-1) receptor. The study will also assess how IBI3042 moves through the body and explore its effects on body weight and related measures. Researchers will evaluate whether single and multiple oral doses of IBI3042 can be administered with acceptable safety and tolerability.\n\nThe study has two parts. In Part A, healthy or overweight participants will receive a single oral dose of IBI3042 or placebo. In Part B, overweight or obese participants will receive multiple oral doses of IBI3042 or placebo over 29 days. Participants will be assigned to different dose groups, and dose escalation will be guided by safety, tolerability, and available drug concentration data from earlier groups.\n\nParticipants will undergo safety assessments and blood sampling during the study. These assessments will include medical examinations, vital signs, laboratory tests, and electrocardiograms. In Part B, researchers will also assess changes in body weight, body mass index, waist circumference, and other metabolic measures.",[146,147,148],"Overweight","Obesity","Heathy Participants",[150,151,152,94],"Pharmacokinetics","Pharmacodynamics","Safety and Tolerability","NOT_YET_RECRUITING","2026-08-31",{"date":156,"type":157},"2026-09-03","ACTUAL",{"date":159,"type":140},"2026-09-02",{"date":161,"type":140},"2027-05-02",{"name":103,"class":6},1]