Genetic, Microbiological and Behavioral Factors in Obesity

ClinicalTrials.gov ID

NCT07650149

Lead Sponsor

Jan Kochanowski UniversityOTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

200Estimated

Last Update Posted

Jun 16, 2026Actual

Start Date

May 23, 2026Actual

Primary Completion Date

May 2027Estimated

Completion Date

May 2028Estimated

Official Title

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

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.

• Obesity & Overweight
• Obesity
• Genetics

• genetic polymorphism
• gut microbiome

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Jan Kochanowski UniversityOTHER

Collaborators

LUX MED GroupOTHER

Justyna.Domienik-Karlowicz@luxmed.pl+48 22 450 45 00

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