Genetic, Microbiological and Behavioral Factors in Obesity (OPTIMIZE-GEN)

June 15, 2026 updated by: Zbigniew Siudak, Jan Kochanowski University

OPTIMIZE GEN - Outcomes of Persistence and Treatment With tIrzepatide deterMined by Genetic, mIcrobiological & 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who are overweight or obese and were prescribed tirzepatide for their treatment

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with BMI>27
tirzepatide treatment
Diagnostic test: genetic polymorphism
GLP1 RA and GIP R polymorphisms will be assesed from venous blood samples
Diagnostic test: gut microbiome
stool samples and oral cavity swabs for gut microbiome will be collected to assess V3 and V4 of gene 16s rRNA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight change
Time Frame: 1 and 6 months
weight change measured in kg and as BMI
1 and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
treatment discontinuation
Time Frame: up to 6 months
number of patients who discontinue treatment prematurely
up to 6 months
adverse reactions
Time Frame: up to 6 months
any adverse gastrointestinal events and complications associated with tirzepatide treatment - frequency and intensity
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jan Kochanowski University

Collaborators

LUX MED Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

June 10, 2026

First Submitted That Met QC Criteria

June 15, 2026

First Posted (Actual)

June 16, 2026

Study Record Updates

Last Update Posted (Actual)

June 16, 2026

Last Update Submitted That Met QC Criteria

June 15, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1/2026 of 6.05.2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We are willing to share data, however, due to the fact that data will come from different clinics and legal entities the form of IPD is to be established.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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