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Estimating the Impact of Obesity Medications on Clinical and Economic Outcomes

8 giugno 2026 aggiornato da: Joshua R. Vest, PhD, Indiana University

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.

Panoramica dello studio

Stato

Iscrizione su invito

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

125000

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Indiana
      • Indianapolis, Indiana, Stati Uniti, 46203
        • Indiana University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Persistent use of incretin-based obesity medication
Persistent 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.
Droga: 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.
Altri nomi:
  • Liraglutide
  • Saxenda
  • Wegovy
  • Semaglutide
  • Diretto in Zep
  • Tirzepatide
No documented receipt of incretin-based obesity medication during observation period
Working-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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in subject body weight.
Lasso di tempo: 6 months periods from 2018 to 2029
Measured in pounds.
6 months periods from 2018 to 2029
Change in subject body mass index (BMI).
Lasso di tempo: 6 months periods from 2018 to 2029
Defined as Weight (kg) / height (m)2.
6 months periods from 2018 to 2029
Change in obesity and overweight classification.
Lasso di tempo: 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)
6 months periods from 2018 to 2029

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in emergency department visits.
Lasso di tempo: 6 months periods from 2018 to 2029
Total visits
6 months periods from 2018 to 2029
Change in obesity-related emergency department visits.
Lasso di tempo: 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).
6 months periods from 2018 to 2029
Change in non-obesity related emergency department visits.
Lasso di tempo: 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).
6 months periods from 2018 to 2029
Change in preventable emergency department visits.
Lasso di tempo: 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).
6 months periods from 2018 to 2029
Change in non-preventable emergency department visits.
Lasso di tempo: 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.
6 months periods from 2018 to 2029
Change in inpatient admissions.
Lasso di tempo: 6 months periods from 2018 to 2029
Total number of distinct hospitalizations (i.e. admissions).
6 months periods from 2018 to 2029
Change in obesity-related inpatient admissions.
Lasso di tempo: 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).
6 months periods from 2018 to 2029
Change in non-obesity-related inpatient admissions.
Lasso di tempo: 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).
6 months periods from 2018 to 2029
Change in inpatient admissions that began in the emergency department.
Lasso di tempo: 6 months periods from 2018 to 2029
Total hospitalizations where the subject was admitted from the emergency department.
6 months periods from 2018 to 2029
Change in direct admit inpatient admissions
Lasso di tempo: 6 months periods from 2018 to 2029
Total hospitalizations that were admitted directly from the community, i.e. not transferred from the emergency department.
6 months periods from 2018 to 2029
Change in 30 day inpatient readmissions.
Lasso di tempo: 6 months periods from 2018 to 2029
Count of hospital admissions (to any facility) occurring within 30 days of a hospital stay.
6 months periods from 2018 to 2029
Change in outpatient visits.
Lasso di tempo: 6 months periods from 2018 to 2029
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.
6 months periods from 2018 to 2029
Change in obesity-related outpatient visits.
Lasso di tempo: 6 months periods from 2018 to 2029

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.
6 months periods from 2018 to 2029
Change in non-obesity-related outpatient visits
Lasso di tempo: 6 months periods from 2018 to 2029

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.
6 months periods from 2018 to 2029
Change in total medical spending.
Lasso di tempo: 6 months periods from 2018 to 2029
All medical costs paid (inpatient, outpatient, emergency department, and rehabilitation costs).
6 months periods from 2018 to 2029
Change in total pharmacy spending.
Lasso di tempo: 6 months periods from 2018 to 2029
All pharmacy costs paid.
6 months periods from 2018 to 2029
Change in total pharmacy spending excluding incretin-based medications.
Lasso di tempo: 6 months periods from 2018 to 2029
All pharmacy costs excluding the cost of incretin obesity medications
6 months periods from 2018 to 2029
Change in total spending on obesity-related complications
Lasso di tempo: 6 months periods from 2018 to 2029

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.
6 months periods from 2018 to 2029

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in absenteeism.
Lasso di tempo: 6 months periods from 2018 to 2029
Total number of sick leave days (costs estimated from published estimates or salary information if available).
6 months periods from 2018 to 2029
Change in retention / turnover.
Lasso di tempo: 6 months periods from 2018 to 2029
Percent of employees that end employment for any reason.
6 months periods from 2018 to 2029
Change in disability claims.
Lasso di tempo: 6 months periods from 2018 to 2029
Total worker's compensation claims regardless of disability period.
6 months periods from 2018 to 2029
Change in clinical A1C laboratory values.
Lasso di tempo: 6 months periods from 2018 to 2029
hemoglobin A1C or HbA1c values
6 months periods from 2018 to 2029
Change in blood pressure laboratory values.
Lasso di tempo: 6 months periods from 2018 to 2029
Systolic and diastolic
6 months periods from 2018 to 2029
Change in cholesterol laboratory values.
Lasso di tempo: 6 months periods from 2018 to 2029
cholesterol blood test (a lipid panel or lipid profile
6 months periods from 2018 to 2029

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Indiana University

Collaboratori

Eli Lilly and Company

Investigatori

  • Investigatore principale: Joshua R Vest, PhD, MPH, Indiana University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2026

Completamento primario (Stimato)

31 dicembre 2029

Completamento dello studio (Stimato)

31 dicembre 2029

Date di iscrizione allo studio

Primo inviato

3 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 giugno 2026

Primo Inserito (Effettivo)

10 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 00855196
  • 26469 (Altro identificatore: Indiana University)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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