[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07595549":3,"trial-entities:NCT07595549":424,"trial-summary:NCT07595549":428},{"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":22,"study_type":35,"primary_purpose":36,"phases":37,"enrollment_info":39,"interventions":42,"primary_outcomes":56,"secondary_outcomes":60,"sex":134,"minimum_age":135,"maximum_age":17,"healthy_volunteers":136,"eligibility_criteria":137,"std_ages":147,"locations":150,"central_contacts":410,"overall_officials":416,"references":419,"see_also_links":420},"NCT07595549","C6491013","A Study to Learn About the Study Medicine Called Berobenatide (PF-08653944) in People With Overweight or Obesity","A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-MONTHLY PF-08653944 IN ADULTS WITH OVERWEIGHT OR OBESITY (VESPER-6)","RECRUITING","2028-06-21","2026-08","2026-08-17","2026-06-10","Pfizer","INDUSTRY",true,"The purpose of this clinical study is to learn about the effects and safety of berobenatide (PF-08653944). This may help people with overweight or obesity lose weight. People in this study may also have type 2 diabetes.\n\nAbout 950 adults will be in this study. Berobenatide will be compared to a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. Berobenatide or placebo is given by a shot under the skin in the belly area. The objective of the study is to compare the experiences of people receiving berobenatide to those of the people who do not to assess if the study medicine is effective and safe.\n\nPeople will take part in this study for about 20 months. During this time, they will have about 15 study visits at the site. They will also have 2 study visits over the phone.",null,[19,20,21],"Obesity","Overweight and\u002For Obesity","Overweight",[23,24,25,26,27,28,29,30,21,19,31,32,33,34],"Overnutrition","Nutrition Disorders","Diabetes Mellitus, Type 2","Type 2 Diabetes","Body Weight","Diabetes Mellitus","Glucose Metabolism Disorders","Endocrine System Diseases","Nutritional and Metabolic Diseases","Signs and Symptoms","Pathological Conditions, Signs and Symptoms","Metabolic Diseases","INTERVENTIONAL","TREATMENT",[38],"PHASE3",{"count":40,"type":41},954,"ESTIMATED",[43,52],{"type":44,"name":45,"description":46,"armGroupLabels":47},"DRUG","PF-08653944","By Subcutaneous Injection",[48,49,50,51],"Treatment Arm 1","Treatment Arm 2","Treatment Arm 3","Treatment Arm 4",{"type":53,"name":54,"description":46,"armGroupLabels":55},"OTHER","Placebo",[54],[57],{"measure":58,"timeFrame":59},"Percent change from baseline in body weight","Baseline, Week 72",[61,63,65,67,69,71,73,75,77,79,81,83,85,88,90,92,94,96,98,100,102,104,106,108,110,112,114,116,118,120,122,124,126,128,130,132],{"measure":62,"timeFrame":59},"Change from baseline in body weight",{"measure":64,"timeFrame":59},"Change from baseline in waist circumference",{"measure":66,"timeFrame":59},"Percentage of Participants achieving ≥5% of body weight reduction from baseline",{"measure":68,"timeFrame":59},"Percentage of Participants achieving ≥10% of body weight reduction from baseline",{"measure":70,"timeFrame":59},"Percentage of Participants achieving ≥15% of body weight reduction from baseline",{"measure":72,"timeFrame":59},"Percentage of Participants achieving ≥20% of body weight reduction from baseline",{"measure":74,"timeFrame":59},"Percentage of Participants with a waist-to-height ratio of \u003C0.53",{"measure":76,"timeFrame":59},"Percent change from baseline in body weight in participants with type 2 diabetes",{"measure":78,"timeFrame":59},"Change from baseline in Systolic Blood Pressure (SBP)",{"measure":80,"timeFrame":59},"Change from baseline in Impact of Weight on Quality of Life-Lite-Clinical Trial (IWQoL-Lite-CT) Physical Function composite score",{"measure":82,"timeFrame":59},"Percentage of Participants achieving ≥25% of body weight reduction from baseline",{"measure":84,"timeFrame":59},"Change from baseline in Diastolic Blood Pressure (DBP)",{"measure":86,"timeFrame":87},"Change from Baseline in Fasting Glucose","Basline, Week 72",{"measure":89,"timeFrame":59},"Change from Baseline in Fasting insulin",{"measure":91,"timeFrame":59},"Change from Baseline in revised Homeostatic Model Assessment insulin sensitivity as a percentage of normal (HOMA2-%S)",{"measure":93,"timeFrame":59},"Change from Baseline in revised Homeostatic Model Assessment beta-cell function as a percentage of a normal reference population (HOMA2-%B)",{"measure":95,"timeFrame":59},"Change from Baseline in HbA1c",{"measure":97,"timeFrame":59},"Change from baseline in Fasting Total Cholesterol",{"measure":99,"timeFrame":59},"Change from baseline in Fasting Low-density lipoprotein cholesterol",{"measure":101,"timeFrame":59},"Change from baseline in Fasting Very low-density lipoprotein cholesterol",{"measure":103,"timeFrame":59},"Change from baseline in Fasting Non-High-density lipoprotein cholesterol",{"measure":105,"timeFrame":59},"Change from baseline in Fasting High-density lipoprotein cholesterol",{"measure":107,"timeFrame":59},"Change from baseline in Fasting triglycerides",{"measure":109,"timeFrame":59},"Change from baseline in high-sensitivity C-reactive protein",{"measure":111,"timeFrame":59},"Change from baseline in interleukin-6",{"measure":113,"timeFrame":59},"Change from baseline in interleukin-1 beta",{"measure":115,"timeFrame":59},"Change from baseline in IWQoL-Lite-CT total score",{"measure":117,"timeFrame":59},"Change from baseline in IWQoL-Lite-CT Physical composite score",{"measure":119,"timeFrame":59},"Change from baseline in IWQoL-Lite-CT Psychosocial composite score",{"measure":121,"timeFrame":59},"Change from baseline in Short Form 36 health survey (SF-36) domain scales and component summary scales",{"measure":123,"timeFrame":59},"Change from Baseline in Control of Eating Questionnaire (CoEQ) subscales",{"measure":125,"timeFrame":59},"Change from Baseline in Food Noise Questionnaire (FNQ) total score",{"measure":127,"timeFrame":59},"Number of Participants With Treatment Emergent Adverse Events (TEAEs)",{"measure":129,"timeFrame":59},"Number of Participants with Serious adverse events (SAEs)",{"measure":131,"timeFrame":59},"Number of Participants with adverse avents leading to discontinuation",{"measure":133,"timeFrame":59},"Number of Participants with Adverse Events of Special Interest (AESIs)","ALL","18 Years",false,{"inclusion":138,"exclusion":141,"raw_text":146},[139,140],"Aged ≥18 years.","BMI of: ≥30 kg\u002Fm2 or ≥27.0 kg\u002Fm2 to \\\u003C30.0 kg\u002Fm2 and must have at least 1 of the following weight-related co-morbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2D.",[142,143,144,145],"Have a self-reported body weight change greater than 5% within 90 days prior to Screening.","Diagnosis of type 1 diabetes or any other form of diabetes other than T2D.","History of acute or chronic pancreatitis.","Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2).","Inclusion Criteria:\n\n* Aged ≥18 years.\n* BMI of: ≥30 kg\u002Fm2 or ≥27.0 kg\u002Fm2 to \\\u003C30.0 kg\u002Fm2 and must have at least 1 of the following weight-related co-morbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2D.\n\nExclusion Criteria:\n\n* Have a self-reported body weight change greater than 5% within 90 days prior to Screening.\n* Diagnosis of type 1 diabetes or any other form of diabetes other than T2D.\n* History of acute or chronic pancreatitis.\n* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2).",[148,149],"ADULT","OLDER_ADULT",[151,161,168,175,182,189,196,203,210,218,225,232,239,242,249,257,265,273,281,289,297,305,312,315,323,327,335,343,351,360,368,376,380,387,396,401,403,406],{"facility":152,"status":153,"city":154,"state":155,"zip":156,"country":157,"geoPoint":158},"San Fernando Valley Health Institute","NOT_YET_RECRUITING","Canoga Park","California","91304","United States",{"lat":159,"lon":160},34.20112,-118.59814,{"facility":162,"status":153,"city":163,"state":155,"zip":164,"country":157,"geoPoint":165},"Headlands Research California, LLC","Escondido","92025",{"lat":166,"lon":167},33.11921,-117.08642,{"facility":169,"status":8,"city":170,"state":155,"zip":171,"country":157,"geoPoint":172},"ImmuniMet, LLC","Modesto","95350",{"lat":173,"lon":174},37.6391,-120.99688,{"facility":176,"status":8,"city":177,"state":155,"zip":178,"country":157,"geoPoint":179},"ClearVue Eye Care","Roseville","95661",{"lat":180,"lon":181},38.75212,-121.28801,{"facility":183,"status":8,"city":184,"state":155,"zip":185,"country":157,"geoPoint":186},"Clinical Trials Research","Sacramento","95821",{"lat":187,"lon":188},38.58157,-121.4944,{"facility":190,"status":8,"city":191,"state":155,"zip":192,"country":157,"geoPoint":193},"University Clinical Investigators, Inc.","Tustin","92780",{"lat":194,"lon":195},33.74585,-117.82617,{"facility":197,"status":8,"city":198,"state":155,"zip":199,"country":157,"geoPoint":200},"Diablo Clinical Research, Inc.","Walnut Creek","94598",{"lat":201,"lon":202},37.90631,-122.06496,{"facility":204,"status":153,"city":205,"state":155,"zip":206,"country":157,"geoPoint":207},"Southern California Retina Specialists","West Hills","91307",{"lat":208,"lon":209},34.19731,-118.64398,{"facility":211,"status":8,"city":212,"state":213,"zip":214,"country":157,"geoPoint":215},"Nature Coast Clinical Research","Crystal River","Florida","34429",{"lat":216,"lon":217},28.90248,-82.5926,{"facility":219,"status":8,"city":220,"state":213,"zip":221,"country":157,"geoPoint":222},"West Coast Eye Institute","Lecanto","34461",{"lat":223,"lon":224},28.85165,-82.4876,{"facility":226,"status":8,"city":227,"state":213,"zip":228,"country":157,"geoPoint":229},"South Broward Research","Miramar","33027",{"lat":230,"lon":231},25.98731,-80.23227,{"facility":233,"status":8,"city":234,"state":213,"zip":235,"country":157,"geoPoint":236},"Suncoast Clinical Research, Inc.","New Port Richey","34652",{"lat":237,"lon":238},28.24418,-82.71927,{"facility":240,"status":8,"city":234,"state":213,"zip":235,"country":157,"geoPoint":241},"West Coast Medical Associates",{"lat":237,"lon":238},{"facility":243,"status":153,"city":244,"state":213,"zip":245,"country":157,"geoPoint":246},"Center for Diabetes, Obesity and Metabolism Inc","Pembroke Pines","33024",{"lat":247,"lon":248},26.00315,-80.22394,{"facility":250,"status":8,"city":251,"state":252,"zip":253,"country":157,"geoPoint":254},"Cedar Crosse Research Center","Chicago","Illinois","60607",{"lat":255,"lon":256},41.85003,-87.65005,{"facility":258,"status":8,"city":259,"state":260,"zip":261,"country":157,"geoPoint":262},"MediSphere Medical Research Center, LLC","Evansville","Indiana","47714",{"lat":263,"lon":264},37.97476,-87.55585,{"facility":266,"status":8,"city":267,"state":268,"zip":269,"country":157,"geoPoint":270},"Monroe Biomedical Research","Louisville","Kentucky","40213",{"lat":271,"lon":272},38.25424,-85.75941,{"facility":274,"status":8,"city":275,"state":276,"zip":277,"country":157,"geoPoint":278},"Aa Mrc Llc","Flint","Michigan","48504",{"lat":279,"lon":280},43.01253,-83.68746,{"facility":282,"status":8,"city":283,"state":284,"zip":285,"country":157,"geoPoint":286},"Albuquerque Clinical Trials, Inc.","Albuquerque","New Mexico","87102",{"lat":287,"lon":288},35.08449,-106.65114,{"facility":290,"status":8,"city":291,"state":292,"zip":293,"country":157,"geoPoint":294},"Rochester Clinical Research, LLC","Rochester","New York","14609",{"lat":295,"lon":296},43.15478,-77.61556,{"facility":298,"status":8,"city":299,"state":300,"zip":301,"country":157,"geoPoint":302},"Medication Management LLC","Greensboro","North Carolina","27405",{"lat":303,"lon":304},36.07264,-79.79198,{"facility":306,"status":8,"city":307,"state":300,"zip":308,"country":157,"geoPoint":309},"Accellacare - Wilmington","Wilmington","28401",{"lat":310,"lon":311},34.23556,-77.94604,{"facility":313,"status":8,"city":307,"state":300,"zip":308,"country":157,"geoPoint":314},"Jeffrey Coleman, OD",{"lat":310,"lon":311},{"facility":316,"status":8,"city":317,"state":318,"zip":319,"country":157,"geoPoint":320},"Midwest Eye 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Auburn","45219",{"lat":321,"lon":322},{"facility":328,"status":8,"city":329,"state":330,"zip":331,"country":157,"geoPoint":332},"VIP Trials","San Antonio","Texas","78230",{"lat":333,"lon":334},29.42412,-98.49363,{"facility":336,"status":8,"city":337,"state":338,"zip":339,"country":157,"geoPoint":340},"York Clinical Research, LLC","Norfolk","Virginia","23504",{"lat":341,"lon":342},36.84681,-76.28522,{"facility":344,"status":153,"city":345,"zip":346,"country":347,"geoPoint":348},"CEPIC - Centro Paulista de Investigação Clínica","São Paulo","04266-010","Brazil",{"lat":349,"lon":350},-23.5475,-46.63611,{"facility":352,"status":8,"city":353,"state":354,"zip":355,"country":356,"geoPoint":357},"Ocean West Research Clinic","Surrey","British Columbia","V3Z2N6","Canada",{"lat":358,"lon":359},49.10635,-122.82509,{"facility":361,"status":153,"city":362,"state":363,"zip":364,"country":356,"geoPoint":365},"GA Research Associates Ltd.","Moncton","New Brunswick","E1G 1A7",{"lat":366,"lon":367},46.09454,-64.7965,{"facility":369,"status":153,"city":370,"state":371,"zip":372,"country":356,"geoPoint":373},"Winterberry Research Inc.","Hamilton","Ontario","L8J 0B6",{"lat":374,"lon":375},43.25011,-79.84963,{"facility":377,"status":8,"city":370,"state":371,"zip":378,"country":356,"geoPoint":379},"The Wharton Medical Clinic Clinical Trials Inc","L8L 5G8",{"lat":374,"lon":375},{"facility":381,"status":153,"city":382,"state":371,"zip":383,"country":356,"geoPoint":384},"Canadian Phase Onward Inc.","Toronto","M3J 0K2",{"lat":385,"lon":386},43.70643,-79.39864,{"facility":388,"status":8,"city":389,"state":390,"zip":391,"country":392,"geoPoint":393},"Medical Corporation Heishinkai OCROM Clinic","Suita","Osaka","565-0853","Japan",{"lat":394,"lon":395},34.76143,135.51567,{"facility":397,"status":8,"city":398,"state":399,"zip":400,"country":392},"Tokyo Center Clinic","Chuo-ku","Tokyo","103-0027",{"facility":402,"status":8,"city":398,"state":399,"zip":400,"country":392},"Tokyo-Eki Center-Building Clinic",{"facility":404,"status":8,"city":398,"state":399,"zip":405,"country":392},"Fukuwa Clinic","104-0031",{"facility":407,"status":8,"city":408,"state":399,"zip":409,"country":392},"Medical Corporation Heishinkai ToCROM Clinic","Shinjuku-ku","160-0008",[411],{"name":412,"role":413,"phone":414,"email":415},"Pfizer CT.gov Call Center","CONTACT","1-800-718-1021","ClinicalTrials.gov_Inquiries@pfizer.com",[417],{"name":412,"affiliation":13,"role":418},"STUDY_DIRECTOR",[],[421],{"label":422,"url":423},"To obtain contact information for a study center near you, click here.","https:\u002F\u002Fpmiform.com\u002Fclinical-trial-info-request?StudyID=C6491013",{"nct_id":4,"conditions":425,"biomarkers":427},[19,21,426],"Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":15,"summary":429,"prompt_version":17},{"design":430,"status":431,"heading":432,"summary":433,"follow_up":434,"word_count":435,"commitments":436,"compensation":437,"drugs_mentioned":438},"This study compares berobenatide to a placebo, involving about 950 adult participants. It is an interventional study, meaning participants will receive a specific treatment.","completed","Berobenatide (PF-08653944) for Overweight or Obesity","This study is looking into a medicine called berobenatide (PF-08653944) to see if it can help people who are overweight or have obesity lose weight. Some participants may also have type 2 diabetes. About 950 adults will join this study. You would receive either berobenatide or a placebo (a shot with no medicine) given under the skin. The main goal is to see how much your body weight changes over 72 weeks (about 1.5 years). To join, you need to be at least 18 years old and have a certain Body Mass Index (BMI). If your BMI is between 27 and 30, you also need to have at least one weight-related health issue like high blood pressure or sleep apnea. The study is currently recruiting participants.","Your body weight will be measured at the beginning of the study and again at Week 72.",126,"You would participate in this study for about 20 months, with approximately 15 visits to the study site.","Not stated in the trial record.",[45,54]]