What this trial means for you
This study is by invitation only — it is not currently taking new participants, but its results may matter for treatments you're considering. It's studying Incretin-based therapies (GLP-1 and GLP-1/GIP) for obesity.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
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 sites by state
Indiana
- Indiana University — Indianapolis
View the official record on ClinicalTrials.gov →
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