[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07640139":3,"trial-entities:NCT07640139":134,"trial-summary:NCT07640139":140},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":43,"secondary_outcomes":54,"sex":109,"minimum_age":110,"maximum_age":111,"healthy_volunteers":14,"eligibility_criteria":112,"std_ages":116,"locations":118,"central_contacts":127,"overall_officials":128,"references":132,"see_also_links":133},"NCT07640139","00855196","Estimating the Impact of Obesity Medications on Clinical and Economic Outcomes","ENROLLING_BY_INVITATION","2029-12-31","2026-06","2026-06-10","2026-01-01","Indiana University","OTHER",false,"The goal of this observational study is to identify the impact of incretin-based obesity medications (e.g., GLP-1 and GLP-1\u002FGIP) on health and economic outcomes among adults who get their health insurance through their employers. The main questions it aims to answer are:\n\n1. Is obesity medication usage is associated with reduced body mass index (BMI) and weight?\n2. Is obesity medication usage is associated with reduced utilization of emergency department and inpatient care or obesity-related conditions over time?\n3. Is obesity medication usage is associated with increased utilization of outpatient care over time?\n4. Is obesity medication usage is associated with slower growth in direct medical costs over time?\n5. Is obesity medication usage is associated with improvements in health measures?\n6. Is obesity medication usage associated with reduced workplace costs?\n\nResearchers will compare individuals who have prescriptions for obesity medications to those without to see if differences in health and costs of care exist.\n\nThe study uses existing medical and pharmacy claims data.","Incretin-based therapies that work by mimicking the action of the natural hormone GLP-1 and GLP-1\u002FGIP have garnered the most excitement and demonstrated promising results in the management of obesity. This project seeks to estimate the impact of incretin-based obesity medications on clinical and economic outcomes in real-world settings. It proposes to fill gaps in the current literature by focusing on patients from self-insured organizations, measuring direct and indirect costs, establishing a long-term cohort, and by merging claims with electronic health record (EHR) data for more comprehensive measures.\n\nThe impact of incretin-based obesity medications on clinical and economic outcomes will be assessed in a dynamic cohort design. The cohort will be drawn from the employees and their working age dependents of large, self-insured (or \"self-funded\") organizations in the state of Indiana (i.e., \"employers\"). Employer organizations agreeing to participate will provide medical and pharmacy claims as well as data on workplace performance (if available) from 2018-2029. The primary exposure of interest is documented receipt of any GLP-1 obesity medication (regardless of manufacturer or brand name). A series of fixed-effects regression models will estimate the association between exposure to incretin-based obesity medications and clinical, utilization, and cost outcomes. This dynamic cohort approach, 1) individuals and participating employer organizations may enter and exit the cohort over time and 2) individuals may switch between on or off exposure over time.",[18],"Obesity",[20,21,22],"GLP-1","Obesity medications","Incretin-based","OBSERVATIONAL",null,[],{"count":27,"type":28},125000,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":36},"DRUG","Incretin-based therapies (GLP-1 and GLP-1\u002FGIP)","Documented receipt of any GLP-1 and GLP-1\u002FGIP obesity medication during an observation period.",[35],"Persistent use of incretin-based obesity medication",[37,38,39,40,41,42],"Zepbound","Tirzepatide","Wegovy","Semaglutide","Saxenda","Liraglutide",[44,48,51],{"measure":45,"description":46,"timeFrame":47},"Change in subject body weight.","Measured in pounds.","6 months periods from 2018 to 2029",{"measure":49,"description":50,"timeFrame":47},"Change in subject body mass index (BMI).","Defined as Weight (kg) \u002F height (m)2.",{"measure":52,"description":53,"timeFrame":47},"Change in obesity and overweight classification.","Body mass index categorized according to Centers for Disease Control \\& Prevention groupings (i.e., normal, overweight, class 1 obesity, class 2 obesity, class 3 obesity)",[55,58,61,64,67,70,73,76,79,82,85,88,91,94,97,100,103,106],{"measure":56,"description":57,"timeFrame":47},"Change in emergency department visits.","Total visits",{"measure":59,"description":60,"timeFrame":47},"Change in obesity-related emergency department visits.","Visit with obesity-related diagnosis code (E66.1-E66.3, Z68.30-768.45), metabolic syndrome, type 2 diabetes, chronic kidney disease, cardiovascular disease, osteoarthritis of the knee, depression, anxiety, metabolic dysfunction-associated steatohepatitis, nonalcoholic fatty liver disease \\& steatohepatitis, obstructive sleep apnea, hyperlipidemia, hypertension, cerebrovascular disease, asthma, gastroesophageal reflux disease (GERD), or chronic obstructive pulmonary disease (COPD).",{"measure":62,"description":63,"timeFrame":47},"Change in non-obesity related emergency department visits.","Visit without any of the following: obesity-related diagnosis code (E66.1-E66.3, Z68.30-768.45), metabolic syndrome, type 2 diabetes, chronic kidney disease, cardiovascular disease, osteoarthritis of the knee, depression, anxiety, metabolic dysfunction-associated steatohepatitis, nonalcoholic fatty liver disease \\& steatohepatitis, obstructive sleep apnea, hyperlipidemia, hypertension, cerebrovascular disease, asthma, gastroesophageal reflux disease (GERD), or chronic obstructive pulmonary disease (COPD).",{"measure":65,"description":66,"timeFrame":47},"Change in preventable emergency department visits.","Preventable visits include those that are:\n\n1. non-emergent (the patient's initial complaint, presenting symptoms, vital signs, medical history, and age indicated that immediate medical care was not required within 12 hours), or\n2. emergent\u002Fprimary care treatable (based on information in the record, treatment was required within 12 hours, but care could have been provided effectively and safely in a primary care setting. The complaint did not require continuous observation, and no procedures were performed or resources used that are not available in a primary care setting), or\n3. preventable\u002Favoidable (Emergency department care was required based on the complaint or procedures performed\u002Fresources used, but the emergent nature of the condition was potentially preventable\u002Favoidable if timely and effective ambulatory care had been received during the episode of illness).",{"measure":68,"description":69,"timeFrame":47},"Change in non-preventable emergency department visits.","Non-preventable visits are defined as emergency department care was required and ambulatory care treatment could not have prevented the condition.",{"measure":71,"description":72,"timeFrame":47},"Change in inpatient admissions.","Total number of distinct hospitalizations (i.e. admissions).",{"measure":74,"description":75,"timeFrame":47},"Change in obesity-related inpatient admissions.","Total hospitalizations with obesity-related diagnosis code (E66.1-E66.3, Z68.30-768.45), metabolic syndrome, type 2 diabetes, chronic kidney disease, cardiovascular disease, osteoarthritis of the knee, depression, anxiety, metabolic dysfunction-associated steatohepatitis, nonalcoholic fatty liver disease \\& steatohepatitis, obstructive sleep apnea, hyperlipidemia, hypertension, cerebrovascular disease, asthma, gastroesophageal reflux disease (GERD), or chronic obstructive pulmonary disease (COPD).",{"measure":77,"description":78,"timeFrame":47},"Change in non-obesity-related inpatient admissions.","Total hospitalizations without obesity-related diagnosis code (E66.1-E66.3, Z68.30-768.45), metabolic syndrome, type 2 diabetes, chronic kidney disease, cardiovascular disease, osteoarthritis of the knee, depression, anxiety, metabolic dysfunction-associated steatohepatitis, nonalcoholic fatty liver disease \\& steatohepatitis, obstructive sleep apnea, hyperlipidemia, hypertension, cerebrovascular disease, asthma, gastroesophageal reflux disease (GERD), or chronic obstructive pulmonary disease (COPD).",{"measure":80,"description":81,"timeFrame":47},"Change in inpatient admissions that began in the emergency department.","Total hospitalizations where the subject was admitted from the emergency department.",{"measure":83,"description":84,"timeFrame":47},"Change in direct admit inpatient admissions","Total hospitalizations that were admitted directly from the community, i.e. not transferred from the emergency department.",{"measure":86,"description":87,"timeFrame":47},"Change in 30 day inpatient readmissions.","Count of hospital admissions (to any facility) occurring within 30 days of a hospital stay.",{"measure":89,"description":90,"timeFrame":47},"Change in outpatient visits.","Any in-person office visits with primary care, family medicine, internal medicine, or any specialty (including behavioral health); excludes phone visits. Total visits, as well as separated by obesity-related vs non-obesity related.",{"measure":92,"description":93,"timeFrame":47},"Change in obesity-related outpatient visits.","Total in-person office visits with primary care, family medicine, internal medicine, or any specialty (including behavioral health) with any of the following: obesity-related diagnosis code (E66.1-E66.3, Z68.30-768.45), metabolic syndrome, type 2 diabetes, chronic kidney disease, cardiovascular disease, osteoarthritis of the knee, depression, anxiety, metabolic dysfunction-associated steatohepatitis, nonalcoholic fatty liver disease \\& steatohepatitis, obstructive sleep apnea, hyperlipidemia, hypertension, cerebrovascular disease, asthma, gastroesophageal reflux disease (GERD), or chronic obstructive pulmonary disease (COPD).\n\nExcludes: phone visits.",{"measure":95,"description":96,"timeFrame":47},"Change in non-obesity-related outpatient visits","Total in-person office visits with primary care, family medicine, internal medicine, or any specialty (including behavioral health) without any of the following: obesity-related diagnosis code (E66.1-E66.3, Z68.30-768.45), metabolic syndrome, type 2 diabetes, chronic kidney disease, cardiovascular disease, osteoarthritis of the knee, depression, anxiety, metabolic dysfunction-associated steatohepatitis, nonalcoholic fatty liver disease \\& steatohepatitis, obstructive sleep apnea, hyperlipidemia, hypertension, cerebrovascular disease, asthma, gastroesophageal reflux disease (GERD), or chronic obstructive pulmonary disease (COPD).\n\nExcludes: phone visits.",{"measure":98,"description":99,"timeFrame":47},"Change in total medical spending.","All medical costs paid (inpatient, outpatient, emergency department, and rehabilitation costs).",{"measure":101,"description":102,"timeFrame":47},"Change in total pharmacy spending.","All pharmacy costs paid.",{"measure":104,"description":105,"timeFrame":47},"Change in total pharmacy spending excluding incretin-based medications.","All pharmacy costs excluding the cost of incretin obesity medications",{"measure":107,"description":108,"timeFrame":47},"Change in total spending on obesity-related complications","All medical costs paid where the claim is associated with any of the following: obesity-related diagnosis code (E66.1-E66.3, Z68.30-768.45), metabolic syndrome, type 2 diabetes, chronic kidney disease, cardiovascular disease, osteoarthritis of the knee, depression, anxiety, metabolic dysfunction-associated steatohepatitis, nonalcoholic fatty liver disease \\& steatohepatitis, obstructive sleep apnea, hyperlipidemia, hypertension, cerebrovascular disease, asthma, gastroesophageal reflux disease (GERD), or chronic obstructive pulmonary disease (COPD).\n\nExcludes: telehealth \u002F phone visits.","ALL","18 Years","64 Years",{"inclusion":113,"exclusion":114,"raw_text":115},[],[],"The study cohort is limited to employees and adult dependents aged 18-64 who receive their health insurance coverage from self-insured Indiana employers that agree to participate in the study.\n\nTo be included in the study, the individuals must:\n\n1. Be an Indiana resident;\n2. Have health insurance benefits provided by participating employers (includes employees and dependents);\n3. Be between the ages of 18 and 64;\n4. Meet the eligibility criteria for an obesity medication prescription:\n\n   1. BMI of ≥ 30 (obesity) or\n   2. BMI of ≥ 25 (overweight) and at least one body weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea, or cardiovascular disease). If the prescribing eligibility criteria are updated in the future, we will update accordingly.\n5. Individuals must have at least 6 months of enrollment prior to study inclusion (i.e., prior to the index date), though we may use additional pre-treatment data if available.\n\nAn individual who meets any of the following criteria will be excluded from participation in the cohort:\n\n1. Has a condition associated with weight loss: a diagnosis of cancer (except for non-melanoma skin cancer), pancreatitis, eating disorders (e.g., anorexia nervosa and avoidant restrictive food intake disorder), HIV, unintentional weight loss, or cirrhosis at baseline;\n2. Has a condition for which obesity medications are contraindicated (for example, medullary thyroid carcinoma, multiple endocrine neoplasia, etc.).\n3. Receipt of diabetes-indicated incretin-based medications. If an individual has a claim for a related incretin-based therapy diabetes medication (e.g., Mounjaro, Ozempic, Rybelsus, Victoza) without an obesity-medication claim during the study period, the individual will be excluded from analysis.\n4. Prior bariatric surgery.\n5. Evidence of prior use of incretin-based obesity medications for weight loss.",[117],"ADULT",[119],{"facility":12,"city":120,"state":121,"zip":122,"country":123,"geoPoint":124},"Indianapolis","Indiana","46203","United States",{"lat":125,"lon":126},39.76838,-86.15804,[],[129],{"name":130,"affiliation":12,"role":131},"Joshua R Vest, PhD, MPH","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":135,"biomarkers":137},[18,136],"Overweight",[138,139],"GCG wt Allele","GIP Gene",{"nct_id":4,"found":14,"summary":24,"prompt_version":24}]