Genetic, Microbiological and Behavioral Factors in Obesity

NCT07650149 — Recruiting, 200 participants, Jan Kochanowski University

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

Registry	NCT07650149, acronym OPTIMIZE-GEN
Status	Recruiting
Study type	Observational
Enrollment	200 (Estimated)
Sponsor	Jan Kochanowski University (Other); collaborators: LUX MED Group
Conditions	Obesity & Overweight, Obesity, Genetics
Interventions	genetic polymorphism, gut microbiome (Diagnostic test)
Dates	start 2026-05-23, primary completion 2027-05-01 (estimated), completion 2028-05-01 (estimated), first posted 2026-06-16, last updated 2026-09-23
Locations	2 sites in Poland

-Summary

This study will assess the impact of genetic markers, microbiological (microbiome) and behavioral factors on tolerance, adherence and effectiveness of dual GLP1/GIP RA in the treatment of obesity.

200 consecutive patients who meet all inclusion and none of the exclusion criteria will be enrolled.

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+Arms and interventions

Arm	Type	Interventions	Description
patients with BMI>27		Diagnostic Test: genetic polymorphism; Diagnostic Test: gut microbiome	tirzepatide treatment

genetic polymorphism (Diagnostic test): GLP1 RA and GIP R polymorphisms will be assesed from venous blood samples
gut microbiome (Diagnostic test): stool samples and oral cavity swabs for gut microbiome will be collected to assess V3 and V4 of gene 16s rRNA

+Outcome measures

Primary outcomes

weight change [1 and 6 months]: weight change measured in kg and as BMI

Secondary outcomes

treatment discontinuation [up to 6 months]: number of patients who discontinue treatment prematurely
adverse reactions [up to 6 months]: any adverse gastrointestinal events and complications associated with tirzepatide treatment - frequency and intensity

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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

+Locations (2)

Facility	City	Country	Status
Waga Zmiany	Krakow	Poland	Recruiting
Luxmed sp zoo	Warsaw	Poland	Recruiting