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ObesityNCT07640139

Estimating the Impact of Obesity Medications on Clinical and Economic Outcomes

An observational study of Obesity, run by Indiana University at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Obesity
What is being tested?
Incretin-based therapies (GLP-1 and GLP-1/GIP)
How many people
125,000 participants
Where
1 siteUnited States
Study dates
1 Jan 2026to 31 Dec 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: Working-age adults and their adult dependents who receive their health insurance coverage from participating, self-insured Indiana employers.

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:
  5. BMI of ≥ 30 (obesity) or
  6. 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.
  7. 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • Indiana University

    Indianapolis, Indiana, 46203

Other trials in United States

About this study

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?
Read more

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.

Read the 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.

Conditions
Obesity
Being tested
Incretin-based therapies (GLP-1 and GLP-1/GIP)
Keywords
GLP-1, Obesity medications, Incretin-based
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Incretin-based therapies (GLP-1 and GLP-1/GIP)Drug

    Also called Zepbound, Tirzepatide, Wegovy, Semaglutide

    Documented receipt of any GLP-1 and GLP-1/GIP obesity medication during an observation period.

Study groups in NCT07640139
Study groupRoleWhat they receive
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.
Receives: Drug: Incretin-based therapies (GLP-1 and GLP-1/GIP)
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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in subject body weight.

    Measured in pounds.

    Measured: 6 months periods from 2018 to 2029

  2. Change in subject body mass index (BMI).

    Defined as Weight (kg) / height (m)2.

    Measured: 6 months periods from 2018 to 2029

  3. 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)

    Measured: 6 months periods from 2018 to 2029

Secondary outcomes (18)
  1. Change in emergency department visits.

    Total visits

    Measured: 6 months periods from 2018 to 2029

  2. 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).

    Measured: 6 months periods from 2018 to 2029

  3. 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).

    Measured: 6 months periods from 2018 to 2029

  4. Change in preventable emergency department visits.

    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).

    Measured: 6 months periods from 2018 to 2029

  5. 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.

    Measured: 6 months periods from 2018 to 2029

  6. Change in inpatient admissions.

    Total number of distinct hospitalizations (i.e. admissions).

    Measured: 6 months periods from 2018 to 2029

  7. 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).

    Measured: 6 months periods from 2018 to 2029

  8. 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).

    Measured: 6 months periods from 2018 to 2029

  9. Change in inpatient admissions that began in the emergency department.

    Total hospitalizations where the subject was admitted from the emergency department.

    Measured: 6 months periods from 2018 to 2029

  10. Change in direct admit inpatient admissions

    Total hospitalizations that were admitted directly from the community, i.e. not transferred from the emergency department.

    Measured: 6 months periods from 2018 to 2029

  11. Change in 30 day inpatient readmissions.

    Count of hospital admissions (to any facility) occurring within 30 days of a hospital stay.

    Measured: 6 months periods from 2018 to 2029

  12. 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.

    Measured: 6 months periods from 2018 to 2029

  13. 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).

    Excludes: phone visits.

    Measured: 6 months periods from 2018 to 2029

  14. 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).

    Excludes: phone visits.

    Measured: 6 months periods from 2018 to 2029

  15. Change in total medical spending.

    All medical costs paid (inpatient, outpatient, emergency department, and rehabilitation costs).

    Measured: 6 months periods from 2018 to 2029

  16. Change in total pharmacy spending.

    All pharmacy costs paid.

    Measured: 6 months periods from 2018 to 2029

  17. Change in total pharmacy spending excluding incretin-based medications.

    All pharmacy costs excluding the cost of incretin obesity medications

    Measured: 6 months periods from 2018 to 2029

  18. 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).

    Excludes: telehealth / phone visits.

    Measured: 6 months periods from 2018 to 2029

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2026
  2. Study start1 Jan 2026
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
125,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07640139
Sponsor's protocol ID
00855196
Other IDs
26469
Status last verified
Jun 2026
First submitted
3 Jun 2026
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Raw and derived data at the patient level will not be publicly posted due to our use of secondary data from privately held claims, electronic health records, and health information exchange systems. Because of data use restrictions among the participating employer organizations contributing claims to the analysis and because of the data use restrictions established by consortium agreements among the health system partners contributing EHR data to the project, patient-level data cannot be shared or disseminated beyond this project. Nevertheless, de-identified derived health information exchange data (only) at the patient-level used in this study may be shared with investigators whose formal requests are approved by the data owners. Requests can be sent to askRDS@regenstrief.org. Access to this data requires investigator support and a signed data access agreement between the Regenstrief Institute and the investigator's institution.

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in subject body weight. (time frame: 6 months periods from 2018 to 2029). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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