Estimating the Impact of Obesity Medications on Clinical and Economic Outcomes
Part of paid clinical trials in Indianapolis, Indiana.
- Sponsor
- Indiana University
- Study ID
- NCT07640139
- Status
- Enrolling By Invitation
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 64 Years
- Healthy Volunteers
- Not accepted
Interventions
- Incretin-based therapies (GLP-1 and GLP-1/GIP) — DRUGDocumented receipt of any GLP-1 and GLP-1/GIP obesity medication during an observation period.
Study Details
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.
Key Dates
- Start date
- Jan 1, 2026
- Status verified
- Jun 2026
- Primary completion
- Dec 31, 2029
- Completion
- Dec 31, 2029
Study Design
- Enrollment
- 125,000 participants (estimated)
Arms
- Arm: Persistent use of incretin-based obesity medicationPersistent use is defined as continuous treatment with no gaps greater than 60 days between prescription fills. Discontinuation is defined as a gap exceeding 60 days following the expected end date of a prescription fill (based on days' supply). Exposure will be measured longitudinally from the index date until discontinuation or censoring. Days of supply will be calculated from pharmacy claims, and we will account for stockpiling by allowing early refills to extend coverage forward in time. If days' supply is missing, it will be imputed using prescribing guidelines or external data sources.
- Arm: No documented receipt of incretin-based obesity medication during observation periodWorking-age adults (age 18 to 64) insured by participating Indiana-based employers that do not use any incretin-based obesity medication for weight loss. Identified by no claim for obesity medications (accounting for days supply and available refills).
Primary Outcome Measure
Change in subject body weight. [ Time Frame: 6 months periods from 2018 to 2029 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 46203 | - |
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