Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07650149

Genetic, Microbiological and Behavioral Factors in Obesity

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Obesity & Overweight Behavior Body Weight Genetics Health Behavior Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Signs and Symptoms Treatment Adherence and Compliance

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Waga Zmiany, Krakow, Poland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. weight change

    Time frame: 1 and 6 months

    weight change measured in kg and as BMI

Secondary outcomes

  1. treatment discontinuation

    Time frame: up to 6 months

    number of patients who discontinue treatment prematurely

  2. adverse reactions

    Time frame: up to 6 months

    any adverse gastrointestinal events and complications associated with tirzepatide treatment - frequency and intensity

Study contacts

Contact information is provided by the study sponsor or research team.

Zbigniew Siudak PI, MD, PhD

CONTACT

[email protected]

+48 41 349 6972

Sponsors and collaborators

Lead sponsor

Jan Kochanowski University

Other

Collaborators

  • LUX MED Group

Registry information

Official study title

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

Acronym: OPTIMIZE-GEN

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 16, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.