Estimating the Impact of Obesity Medications on Clinical and Economic Outcomes

NCT07640139 | Enrolling By Invitation FDA Drug

• 2 other identifiers: 0085519626469
• Study Type: observational
• Target: 125,000
• Locations: 1 country
• Sites: 1

Brief 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. 1.Is obesity medication usage is associated with reduced body mass index (BMI) and weight?
2. 2.Is obesity medication usage is associated with reduced utilization of emergency department and inpatient care or obesity-related conditions over time?
3. 3.Is obesity medication usage is associated with increased utilization of outpatient care over time?
4. 4.Is obesity medication usage is associated with slower growth in direct medical costs over time?
5. 5.Is obesity medication usage is associated with improvements in health measures?
6. 6.Is obesity medication usage associated with reduced workplace costs?

Conditions

Obesity

Keywords

GLP-1; Obesity medications; Incretin-based

Outcome Measures

Primary Outcomes (3)

• Change in subject body weight.

  Measured in pounds.

  6 months periods from 2018 to 2029

• Change in subject body mass index (BMI).

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

  6 months periods from 2018 to 2029

• 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)

  6 months periods from 2018 to 2029

Secondary Outcomes (18)

• Change in emergency department visits.

  6 months periods from 2018 to 2029

• Change in obesity-related emergency department visits.

  6 months periods from 2018 to 2029

• Change in non-obesity related emergency department visits.

  6 months periods from 2018 to 2029

• Change in preventable emergency department visits.

  6 months periods from 2018 to 2029

• Change in non-preventable emergency department visits.

  6 months periods from 2018 to 2029

Other Outcomes (6)

• Change in absenteeism.

  6 months periods from 2018 to 2029

• Change in retention / turnover.

  6 months periods from 2018 to 2029

• Change in disability claims.

  6 months periods from 2018 to 2029

Study Arms (2)

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.

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

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).

Interventions

Incretin-based therapies (GLP-1 and GLP-1/GIP) DRUG

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

Also known as: Zepbound, Tirzepatide, Wegovy, Semaglutide, Saxenda, Liraglutide

Persistent use of incretin-based obesity medication

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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: 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Indiana University: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46203, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Glucagon-Like Peptide 1; Tirzepatide; semaglutide; Liraglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• Joshua R Vest, PhD, MPH

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Associate Dean for Research

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 10, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)