[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587125":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":51,"centralContacts":55,"locations":60,"responsibleParty":74,"collaborators":42,"id":76,"slug":42,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":42,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":42,"studyType":89,"phases":90,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":63,"whyStopped":42,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Pfizer","INDUSTRY",[8,15,19,23,27,31],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A Cohort","EXPERIMENTAL","Cohort participants will receive single co-administered ascending dose (SAD) of subcutaneous (SC) MET233 and SC MET097 or matched SC placebo.",[13,14],"Drug: MET233 and MET097","Other: Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"Part B Cohort","Cohort Participants will receive multiple ascending dose (MAD) of co-administered SC MET233 with SC MET097 or matched SC placebo.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Part C Cohort","Cohort Participants will receive multiple doses of SC MET233 co-administered with SC MET097 or matched SC placebo in participants with T2DM.",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"Part D Cohort","Cohort Participants will receive multiple doses of weekly and monthly (ie, every 4 weeks \\[QM\\]) co-administered SC MET233 with SC MET097, or matched SC placebo in participants with obesity.",[13,14],{"label":28,"type":10,"description":29,"interventionNames":30},"Part E Cohort","Cohort Participants will receive multiple dose QW-to-QM of SC MET233 co-administered with SC MET097 or matched SC placebo in participants with obesity.",[13,14],{"label":32,"type":10,"description":33,"interventionNames":34},"Part G Cohort","Cohort Participants will receive multiple dose cohort of QW and QM SC MET097 monotherapy or matched SC placebo in participants with obesity or overweight.",[14,35],"Drug: MET097",[37,43,48],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"DRUG","MET233 and MET097","For subcutaneous administration",[9,16,20,24,28],null,{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":42},"OTHER","Placebo","Sterile 0.9% (w\u002Fv) saline for subcutaneous administration.",[9,16,20,24,28,32],{"type":38,"name":49,"description":40,"armGroupLabels":50,"otherNames":42},"MET097",[32],[52],{"name":53,"affiliation":5,"role":54},"Pfizer CT.gov Call Center","STUDY_DIRECTOR",[56],{"name":53,"role":57,"phone":58,"phoneExt":42,"email":59},"CONTACT","1-800-718-1021","ClinicalTrials.gov_Inquiries@pfizer.com",[61],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":42},"Altasciences Clinical Los Angeles, Inc.","RECRUITING","Cypress","California","90630","United States",{"type":69,"coordinates":70},"Point",[71,72],-118.03729,33.81696,{"lat":72,"lon":71},{"type":75,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100587125",false,"NCT06924320","A Study of MET233 in Combination With MET097 in Individuals With Obesity or Overweight With or Without Diabetes","A PHASE 1\u002F2A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, SINGLE AND MULTIPLE ASCENDING DOSE STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MET233 CO-ADMINISTERED WITH MET097 IN ADULT PARTICIPANTS WITH OBESITY OR OVERWEIGHT INCLUDING PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS","Inclusion Criteria:\n\n* Adult males or females aged 18 to 75 years (inclusive) at the time of screening.\n* BMI ≥27.0 kg\u002Fm2 and ≤38.0 kg\u002Fm2 (inclusive) at Screening for Parts A, B, and C, and ≥30.0 kg\u002Fm2 and ≤45.0 kg\u002Fm2 (inclusive) at Screening for Parts D and E. Have a BMI ≥27.0 kg\u002Fm2 and ≤45.0 kg\u002Fm2 (inclusive) at Screening for Parts G.\n* Participants must be in generally stable health, as determined by the investigator based on medical history, physical examination (including vital signs), laboratory evaluations, and electrocardiogram (ECG).\n\n  * Participants must have no clinically significant diseases or clinically significant findings on the physical examination (including vital signs), laboratory evaluations, and electrocardiogram (ECG).\n  * Participants in Parts C must not have clinically significant diseases except type 2 diabetes mellitus (T2DM), sleep apnea, well-controlled hypertension, and\u002For dyslipidemia.\n  * Participants in Parts E and G must not have any clinically significant diseases except hypertension, dyslipidemia, and\u002For a clinical diagnosis of sleep apnea.\n* Willing and able to comply with all scheduled study visits, procedures, and required assessments.\n* Women of childbearing potential must be willing to comply with protocol-specified contraceptive requirements and must not plan to become pregnant during the study.\n\nExclusion Criteria:\n\n* Female who is lactating or who is pregnant according to the pregnancy test at Screening or on Day 1. Unwillingness or inability to comply with protocol-specified contraceptive requirements.\n* Clinically significant abnormalities in laboratory results in the opinion of the investigator, increase risk or interfere with study participation.\n* Seated blood pressure higher than 160\u002F100 mmHg at the Screening visit or prior to the first study drug administration.\n* Elevated resting pulse greater than 100 beats per minute at Screening visit or prior to the first study drug administration.\n* Estimated glomerular filtration rate (eGFR) \\\u003C80 mL\u002Fmin at the Screening visit.\n* Diagnosis of Type 1 diabetes.\n* For Part A, Part B, Part D, Part E and Part G: Diagnosis of T2DM or glycated hemoglobin (HbA1c) \\> 6.4% or fasting plasma glucose \\>126 mg\u002FdL at the Screening visit or history of taking any medications to lower glucose.\n* For Part A, Part B and Part D: Participant reported weight-related comorbidity, including sleep apnea and cardiovascular disease.\n* Use of prohibited prescription or non-prescription medications, supplements, or investigational products within protocol-defined washout periods.\n* History or presence of clinically significant gastrointestinal, endocrine, respiratory, renal, hepatic, hematologic, neurologic, cardiovascular, psychiatric, immunologic, or other systemic diseases, except where explicitly permitted by the protocol.\n* Personal or family history of medullary thyroid carcinoma, multiple endocrine neoplasia syndrome, pancreatitis, or pancreatic cancer.\n* History of acute or chronic pancreatitis or pancreatic cancer.\n* Participation in a weight loss program with or without pharmacotherapy during the 3 months prior to study administration or plans to do so.\n* History of bariatric or weight-loss surgery.\n* Clinically significant psychiatric illness that may interfere with study participation or safety.\n* Screening assessments indicative of moderate to severe depression.\n* History of drug or alcohol abuse or dependence within the past 2 years.",true,"ALL","18 Years","75 Years",{"count":87,"type":88},381,"ESTIMATED","INTERVENTIONAL",[91,92],"PHASE1","PHASE2","This study is designed to test how well the combination of MET233 with MET097 works to treat individuals with obesity or overweight with or without diabetes.",[95],"Obesity and Obesity-related Medical Conditions",[97,98],"GLP-1","Metsera","2026-05-28",{"date":101,"type":102},"2026-06-01","ACTUAL",{"date":104,"type":102},"2025-03-06",{"date":106,"type":88},"2026-09-15",{"name":5,"class":6},1]