ClinicalTrials.gg
RecruitingNCT07650149OPTIMIZE-GENUpdated Sep 23, 2026

Genetic, Microbiological and Behavioral Factors in Obesity

An observational study in Obesity & Overweight, Obesity and Genetics, sponsored by Jan Kochanowski University. Recruiting at 2 sites in Poland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Jan Kochanowski University · Observational

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity & Overweight
  • Obesity
  • Genetics

Keywords

  • tirzepatide
  • obesity
  • genetics
  • microbiom
  • adherence
  • compliance
  • gene
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 200 is above the median of 114 across 2,154 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Jan Kochanowski University is the lead sponsor of 6 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18-65 years
  • Consent to participate in the study and providing informed written consent
  • Overweight or obese with a >27

Exclusion criteria

Exclusion criteria

  • to tirzepatide use:
  • Type 1 or type 2 diabetes
  • Pregnancy or breastfeeding
  • Cancer
  • Heart failure
  • Expected lack of patient compliance
  • Taking medications, , NSAIDs, antibiotics (within 2 weeks prior to sample collection),
  • and inflammatory diseases, acute infectious diseases, AIDS, tuberculosis
  • Mental illness
  • Alcohol dependence syndrome
  • Liver cirrhosis
  • Post-myocardial infarction or stroke
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • patients with BMI>27

    tirzepatide treatment

    Diagnostic Test: genetic polymorphism · Diagnostic Test: gut microbiome

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

This study also gives Tirzepatide. No intervention listed here names it: that was found by reading the record.

06

What researchers measure

Primary outcomes

  1. weight change

    weight change measured in kg and as BMI

    Time frame: 1 and 6 months

Secondary outcomes

  1. treatment discontinuation

    number of patients who discontinue treatment prematurely

    Time frame: up to 6 months

  2. adverse reactions

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

    Time frame: up to 6 months

07

Study locations

2 of 2 sites recruiting
  • Waga Zmiany
    Krakow, Poland
    Recruiting
  • Luxmed sp zoo
    Warsaw, Poland
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2026 (actual). Primary completion is estimated for May 2027, 12 months after the start.

Of 791 non-industry observational studies under Obesity, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 106. This study's planned 12 months is below that.

Counting every sponsor, half of 836 studies reached it within 39 months; a quarter within 17 and three quarters within 96.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 10, 2026
First posted
Jun 16, 2026
StartActual
May 23, 2026
Primary completionEst.
May 2027
CompletionEst.
May 2028
Last update
Sep 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07650149
Lead sponsor
Jan Kochanowski University
Collaborators
LUX MED Group
Responsible party
Zbigniew Siudak (Principal Investigator, Jan Kochanowski University) — Principal investigator
First posted
Jun 16, 2026
Start date
May 23, 2026
Primary completion
May 2027 (estimated)
Completion
May 2028 (estimated)
Last update
Sep 23, 2026

Study contacts

Zbigniew Siudak PI, MD, PhD
Contact
zbigniew.siudak@ujk.edu.pl
+48 41 349 6972

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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