GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT07640139

Enrolling by invitation

Estimating the Impact of Obesity Medications on Clinical and Economic Outcomes

Lead sponsor

Indiana University

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

—

Enrollment

125,000

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoints

•Subject body weight•Subject body mass index (BMI)•Obesity and overweight classification

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07640139

Org study ID00855196

Secondary ID26469Indiana University

Timeline

Milestones

Study start2026-01-01actual

Study first posted2026-06-10actual

Last update posted2026-06-10actual

Primary completion2029-12-31estimated

Study completion2029-12-31estimated

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age64 Years

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

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

Eligibility criteria

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.

Endpoints (27)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Weight & body composition

Cardiometabolic biomarkers

Safety / tolerability / PK

Other clinical outcomes