Genetic, Microbiological and Behavioral Factors in Obesity

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07650149

Acronym

OPTIMIZE-GEN

Enrollment

200

Registered

2026-06-16

Start date

2026-05-23

Completion date

2028-05-01

Last updated

2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genetics, Obesity, Obesity & Overweight

Keywords

tirzepatide, obesity, genetics, microbiom, adherence, compliance, gene

Brief 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.

Interventions

DIAGNOSTIC_TESTgenetic polymorphism

GLP1 RA and GIP R polymorphisms will be assesed from venous blood samples

DIAGNOSTIC_TESTgut microbiome

stool samples and oral cavity swabs for gut microbiome will be collected to assess V3 and V4 of gene 16s rRNA

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
weight change	1 and 6 months	weight change measured in kg and as BMI

Secondary

Measure	Time frame	Description
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

Countries

Poland

Contacts

CONTACTZbigniew Siudak PI, MD, PhD

zbigniew.siudak@ujk.edu.pl+48 41 349 6972

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026