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Estimating the Impact of Obesity Medications on Clinical and Economic Outcomes

8 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rejestracja na zaproszenie

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

125000

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Indiana
      • Indianapolis, Indiana, Stany Zjednoczone, 46203
        • Indiana University

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
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.
Lek: 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.
Inne nazwy:
  • Liraglutyd
  • Saxenda
  • Węgowy
  • Semaglutyd
  • Związany
  • Tyrzepatid
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).

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in subject body weight.
Ramy czasowe: 6 months periods from 2018 to 2029
Measured in pounds.
6 months periods from 2018 to 2029
Change in subject body mass index (BMI).
Ramy czasowe: 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.
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in emergency department visits.
Ramy czasowe: 6 months periods from 2018 to 2029
Total visits
6 months periods from 2018 to 2029
Change in obesity-related emergency department visits.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Change in absenteeism.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 6 months periods from 2018 to 2029
Systolic and diastolic
6 months periods from 2018 to 2029
Change in cholesterol laboratory values.
Ramy czasowe: 6 months periods from 2018 to 2029
cholesterol blood test (a lipid panel or lipid profile
6 months periods from 2018 to 2029

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Indiana University

Współpracownicy

Eli Lilly and Company

Śledczy

  • Główny śledczy: Joshua R Vest, PhD, MPH, Indiana University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 stycznia 2026

Zakończenie podstawowe (Szacowany)

31 grudnia 2029

Ukończenie studiów (Szacowany)

31 grudnia 2029

Daty rejestracji na studia

Pierwszy przesłany

3 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

8 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

10 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

10 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

8 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 00855196
  • 26469 (Inny identyfikator: Indiana University)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu 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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Tak

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Incretin-based therapies (GLP-1 and GLP-1/GIP)

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