Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Estimating the Impact of Obesity Medications on Clinical and Economic Outcomes

8. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Anmeldung auf Einladung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

125000

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Indiana
      • Indianapolis, Indiana, Vereinigte Staaten, 46203
        • Indiana University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Arzneimittel: 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.
Andere Namen:
  • Liraglutid
  • Saxenda
  • Wegovy
  • Semaglutid
  • Zepbound
  • Tirzepatid
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).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in subject body weight.
Zeitfenster: 6 months periods from 2018 to 2029
Measured in pounds.
6 months periods from 2018 to 2029
Change in subject body mass index (BMI).
Zeitfenster: 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.
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in emergency department visits.
Zeitfenster: 6 months periods from 2018 to 2029
Total visits
6 months periods from 2018 to 2029
Change in obesity-related emergency department visits.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in absenteeism.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 6 months periods from 2018 to 2029
Systolic and diastolic
6 months periods from 2018 to 2029
Change in cholesterol laboratory values.
Zeitfenster: 6 months periods from 2018 to 2029
cholesterol blood test (a lipid panel or lipid profile
6 months periods from 2018 to 2029

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Indiana University

Mitarbeiter

Eli Lilly and Company

Ermittler

  • Hauptermittler: Joshua R Vest, PhD, MPH, Indiana University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Januar 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2029

Studienabschluss (Geschätzt)

31. Dezember 2029

Studienanmeldedaten

Zuerst eingereicht

3. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Juni 2026

Zuerst gepostet (Tatsächlich)

10. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 00855196
  • 26469 (Andere Kennung: Indiana University)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Ja

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Incretin-based therapies (GLP-1 and GLP-1/GIP)

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Egypt

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

Abonnieren