DRUG
Incretin-based therapies (GLP-1 and GLP-1/GIP)
Documented receipt of any GLP-1 and GLP-1/GIP obesity medication during an observation period.
Estimating the Impact of Obesity Medications on Clinical and Economic Outcomes
Status
Enrolling by invitation
Phase
Not applicable
Enrollment
125,000
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
The goal of this observational study is to identify the impact of incretin-based obesity medications (e.g., GLP-1 and GLP-1/GIP) on health and economic outcomes among adults who get their health insurance through their employers. The main questions it aims to answer are: 1. Is obesity medication usage is associated with reduced body mass index (BMI) and weight? 2. Is obesity medication usage is associated with reduced utilization of emergency department and inpatient care or obesity-related conditions over time? 3. Is obesity medication usage is associated with increased utilization of outpatient care over time? 4. Is obesity medication usage is associated with slower growth in direct medical costs over time? 5. Is obesity medication usage is associated with improvements in health measures? 6. Is obesity medication usage associated with reduced workplace costs? Researchers will compare individuals who have prescriptions for obesity medications to those without to see if differences in health and costs of care exist. The study uses existing medical and pharmacy claims data.
Full detailed description
Incretin-based therapies that work by mimicking the action of the natural hormone GLP-1 and GLP-1/GIP 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. The 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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Jun 10, 2026
Study start
Jan 1, 2026
Primary completion
Dec 31, 2029
Study completion
Dec 31, 2029
Results posted
Not reported
Registry updated
Jun 10, 2026
Outcomes
What the study measures.
Primary outcomes
Change in subject body weight.
Time frame · 6 months periods from 2018 to 2029
Measured in pounds.
Change in subject body mass index (BMI).
Time frame · 6 months periods from 2018 to 2029
Defined as Weight (kg) / height (m)2.
Change in obesity and overweight classification.
Time frame · 6 months periods from 2018 to 2029
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)
Secondary outcomes
Change in emergency department visits.
Time frame · 6 months periods from 2018 to 2029
Total visits
Change in obesity-related emergency department visits.
Time frame · 6 months periods from 2018 to 2029
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).
Change in non-obesity related emergency department visits.
Time frame · 6 months periods from 2018 to 2029
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).
Change in preventable emergency department visits.
Time frame · 6 months periods from 2018 to 2029
Preventable visits include those that are: 1. 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 2. emergent/primary 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 3. preventable/avoidable (Emergency department care was required based on the complaint or procedures performed/resources used, but the emergent nature of the condition was potentially preventable/avoidable if timely and effective ambulatory care had been received during the episode of illness).
Change in non-preventable emergency department visits.
Time frame · 6 months periods from 2018 to 2029
Non-preventable visits are defined as emergency department care was required and ambulatory care treatment could not have prevented the condition.
Change in inpatient admissions.
Time frame · 6 months periods from 2018 to 2029
Total number of distinct hospitalizations (i.e. admissions).
Change in obesity-related inpatient admissions.
Time frame · 6 months periods from 2018 to 2029
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).
Change in non-obesity-related inpatient admissions.
Time frame · 6 months periods from 2018 to 2029
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).
Change in inpatient admissions that began in the emergency department.
Time frame · 6 months periods from 2018 to 2029
Total hospitalizations where the subject was admitted from the emergency department.
Change in direct admit inpatient admissions
Time frame · 6 months periods from 2018 to 2029
Total hospitalizations that were admitted directly from the community, i.e. not transferred from the emergency department.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 64 Years
- Sex
- ALL
- Healthy volunteers
- No
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. To be included in the study, the individuals must: 1. Be an Indiana resident; 2. Have health insurance benefits provided by participating employers (includes employees and dependents); 3. Be between the ages of 18 and 64; 4. Meet the eligibility criteria for an obesity medication prescription: 1. BMI of ≥ 30 (obesity) or 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. 5. 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. An individual who meets any of the following criteria will be excluded from participation in the cohort: 1. 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; 2. Has a condition for which obesity medications are contraindicated (for example, medullary thyroid carcinoma, multiple endocrine neoplasia, etc.). 3. 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. 4. Prior bariatric surgery. 5. Evidence of prior use of incretin-based obesity medications for weight loss.
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Indiana University
Indianapolis, Indiana, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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