此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Estimating the Impact of Obesity Medications on Clinical and Economic Outcomes

2026年6月8日 更新者：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.

研究概览

地位

邀请报名

条件

干预/治疗

详细说明

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.

研究类型

观察性的

注册 (估计的)

125000

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Indiana
      • Indianapolis、Indiana、美国、46203
        • Indiana University

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

取样方法

非概率样本

研究人群

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

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
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.
药品：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.
其他名称：
  • 利拉鲁肽
  • 萨克森达
  • 维高威
  • 索马鲁肽
  • 泽普邦德
  • 替泽帕肽
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).

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in subject body weight.
大体时间：6 months periods from 2018 to 2029
Measured in pounds.
6 months periods from 2018 to 2029
Change in subject body mass index (BMI).
大体时间：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.
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Change in emergency department visits.
大体时间：6 months periods from 2018 to 2029
Total visits
6 months periods from 2018 to 2029
Change in obesity-related emergency department visits.
大体时间：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.
大体时间：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.
大体时间：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.
大体时间：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.
大体时间：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.
大体时间：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.
大体时间：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.
大体时间：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
大体时间：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.
大体时间：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.
大体时间：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.
大体时间：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
大体时间：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.
大体时间：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.
大体时间：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.
大体时间：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
大体时间：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

其他结果措施

结果测量
措施说明
大体时间
Change in absenteeism.
大体时间：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.
大体时间：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.
大体时间：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.
大体时间：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.
大体时间：6 months periods from 2018 to 2029
Systolic and diastolic
6 months periods from 2018 to 2029
Change in cholesterol laboratory values.
大体时间：6 months periods from 2018 to 2029
cholesterol blood test (a lipid panel or lipid profile
6 months periods from 2018 to 2029

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Indiana University

合作者

Eli Lilly and Company

调查人员

  • 首席研究员：Joshua R Vest, PhD, MPH、Indiana University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年1月1日

初级完成 (估计的)

2029年12月31日

研究完成 (估计的)

2029年12月31日

研究注册日期

首次提交

2026年6月3日

首先提交符合 QC 标准的

2026年6月8日

首次发布 (实际的)

2026年6月10日

研究记录更新

最后更新发布 (实际的)

2026年6月10日

上次提交的符合 QC 标准的更新

2026年6月8日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 00855196
  • 26469 (其他标识符：Indiana University)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅