Obesity & OverweightOPTIMIZE-GENNCT07650149
Genetic, Microbiological and Behavioral Factors in Obesity
An observational study of Obesity & Overweight and Obesity, run by Jan Kochanowski University at 2 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity & Overweight, Obesity, Genetics
- What is being tested?
- genetic polymorphism and gut microbiome
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 2 sitesPoland
- Study dates
- 23 May 2026to May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are overweight or obese and were prescribed tirzepatide for their treatment
Who may be able to join
- Age 18-65 years
- Consent to participate in the study and providing informed written consent
- Overweight or obese with a BMI >27
Who cannot join
- Contraindications to tirzepatide use:
- Type 1 or type 2 diabetes
- Pregnancy or breastfeeding
- Cancer
- Heart failure
- Expected lack of patient compliance
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland2 sites, 2 recruiting
- Recruiting
Waga Zmiany
Krakow
Tomasz Witaszek PI, MD, +48883992287, kontakt@wagazmiany.pl
- Recruiting
Luxmed sp zoo
Warsaw
Justyna Domienik-Karlowicz PI, MD, PhD, +48 22 450 45 00, Justyna.Domienik-Karlowicz@luxmed.pl
About this study
Official title: 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.
- Conditions
- Obesity & Overweight, Obesity, Genetics
- Being tested
- genetic polymorphism, gut microbiome
- Keywords
- tirzepatide, obesity, genetics, microbiom, adherence, compliance, gene
- Medical subject headings
- Obesity, Overweight, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genetic polymorphismDiagnostic test
GLP1 RA and GIP R polymorphisms will be assesed from venous blood samples
gut microbiomeDiagnostic test
stool samples and oral cavity swabs for gut microbiome will be collected to assess V3 and V4 of gene 16s rRNA
| Study group | Role | What they receive |
|---|---|---|
| patients with BMI>27 | tirzepatide treatment Receives: Diagnostic Test: genetic polymorphism; Diagnostic Test: gut microbiome |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight change
weight change measured in kg and as BMI
Measured: 1 and 6 months
Secondary outcomes (2)
treatment discontinuation
number of patients who discontinue treatment prematurely
Measured: up to 6 months
adverse reactions
any adverse gastrointestinal events and complications associated with tirzepatide treatment - frequency and intensity
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start23 May 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jan Kochanowski University
- Sponsor type
- University, hospital or other
- Collaborators
- LUX MED Group
- Responsible party
- Principal investigator, Zbigniew Siudak, Jan Kochanowski University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07650149
- Sponsor's protocol ID
- 1/2026 of 6.05.2026
- Acronym
- OPTIMIZE-GEN
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTIMIZE GEN - Outcomes of Persistence and Treatment With tIrzepatide deterMined by Genetic, mIcrobiological & bEhavioral Factors in obEsity
- ClinicalTrials.gov ID
- NCT07650149
- Acronym / sponsor ID
- OPTIMIZE-GEN / 1/2026 of 6.05.2026
- Conditions
- Obesity & Overweight, Obesity, Genetics
- Keywords
- tirzepatide, obesity, genetics, microbiom, adherence, compliance, gene
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jan Kochanowski UniversityUniversity, hospital or other
- Collaborators
- LUX MED Group
- Study start
- 23 May 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with BMI>27 | – | Diagnostic Test: genetic polymorphism, Diagnostic Test: gut microbiometirzepatide treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are overweight or obese and were prescribed tirzepatide for their treatment
Key inclusion criteria (3 listed)
- Age 18-65 years
- Consent to participate in the study and providing informed written consent
- Overweight or obese with a BMI >27
Key exclusion criteria (12 listed)
- Contraindications to tirzepatide use:
- Type 1 or type 2 diabetes
- Pregnancy or breastfeeding
- Cancer
- Heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| genetic polymorphismGLP1 RA and GIP R polymorphisms will be assesed from venous blood samples | Diagnostic test | patients with BMI>27 |
| gut microbiomestool samples and oral cavity swabs for gut microbiome will be collected to assess V3 and V4 of gene 16s rRNA | Diagnostic test | patients with BMI>27 |
Primary outcome
weight change
Time frame: 1 and 6 months
weight change measured in kg and as BMI
2 secondary outcomes
treatment discontinuation
Time frame: up to 6 months
adverse reactions
Time frame: up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity & Overweight and Obesity, run by Jan Kochanowski University at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zbigniew Siudak PI, MD, PhD (+48 41 349 6972, zbigniew.siudak@ujk.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight change (time frame: 1 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.