Genetic, Microbiome, and Behavioral Factors in Obesity
Official title: OPTIMIZE GEN - Outcomes of Persistence and Treatment With tIrzepatide deterMined by Genetic, mIcrobiological & bEhavioral Factors in obEsity
Run by Jan Kochanowski University · NCT07650149 · Data updated 2026-11-12
This study will test whether genetic, gut microbiome, and behavioral factors affect how people tolerate, adhere to, and respond to a dual GLP-1/GIP medicine for obesity.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Jan Kochanowski University Academic / other |
| Locations | 2 sites (Krakow and 1 other locations) |
| Status | Recruiting |
| Started | May 23, 2026 |
| Main results expected | May 2027 |
| Study ends | May 2028 |
| Registry record updated | September 23, 2026 |
| Trial ID | NCT07650149 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–65 who are overweight or obese (BMI >27) and able to provide informed consent.
✕Probably not a fit
Individuals with contraindications to tirzepatide or certain medical conditions may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will enroll 200 adults aged 18–65 with overweight or obesity to examine how genetic polymorphisms, gut microbiome composition, and behavioral patterns relate to treatment tolerance, adherence, and effectiveness of a dual GLP-1/GIP receptor agonist. Data on genetics, microbiome and behaviors will be collected and analyzed alongside treatment outcomes. The study aims to identify markers that might predict who benefits most from this therapy. No intervention beyond standard care with the dual agonist is described in detail, and the primary focus is on associations rather than randomization or efficacy comparison. Lead sites are in Krakow and Warsaw, with collaboration from a private medical group.
Why it matters
Potential benefit: If successful, findings could help tailor obesity treatment to individuals based on their genetics, microbiome, and behaviors.
How similar studies have gone: Previous research has begun to explore how genetics and the microbiome relate to obesity therapies, but this specific design is exploratory and not yet proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria * Age 18-65 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
Where it's running
-
Waga Zmiany
Krakow, Poland Recruiting -
Luxmed sp zoo
Warsaw, Poland Recruiting
Study contacts
- Study coordinator: Zbigniew Siudak PI, MD, PhD
- Email: zbigniew.siudak@ujk.edu.pl
- Phone: +48 41 349 6972
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.