OPTIMIZE-GEN

Recruiting

Genetic, Microbiological and Behavioral Factors in Obesity

OPTIMIZE GEN - Outcomes of Persistence and Treatment With tIrzepatide deterMined by Genetic, mIcrobiological & bEhavioral Factors in obEsity

Lead sponsor

Jan Kochanowski University

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Enrollment

200

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥27

Primary endpoint

•Weight change

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 IDNCT07650149

Org study ID1/2026 of 6.05.2026

Timeline

Milestones

Study start2026-05-23actual

Study first posted2026-06-16actual

Last update posted2026-06-16actual

Primary completion2027-05estimated (month precision)

Study completion2028-05estimated (month precision)

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age60 Years

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

Patients who are overweight or obese and were prescribed tirzepatide for their treatment

Inclusion criteria

•Age 18-60 years

•Consent to participate in the study and providing informed written consent

•Overweight or obese with a BMI >27

Exclusion criteria

•Contraindications to tirzepatide use:

•Type 1 or type 2 diabetes

•Pregnancy or breastfeeding

•Cancer

•Heart failure

•Expected lack of patient compliance

•Taking immunosuppressive medications, steroids, NSAIDs, antibiotics (within 2 weeks prior to sample collection),

•Autoimmune and inflammatory diseases, acute infectious diseases, AIDS, tuberculosis

•Mental illness

•Alcohol dependence syndrome

•Liver cirrhosis

•Post-myocardial infarction or stroke

Endpoints (3)

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

1 endpoint

Primary/protocol endpoint

weight change

Time frame:1 and 6 months

descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

treatment discontinuation

Time frame:up to 6 months

descriptive

Secondary/protocol endpoint/low confidence

adverse reactions

Time frame:up to 6 months

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.