PreDiabetesGAROSNCT05340868
Genetics of the Acute Response to Oral Semaglutide
A study testing Semaglutide Pill in people with PreDiabetes and Prediabetic State, run by Medical University of Bialystok at 1 site in Poland.
Trial summary
The study aims to investigate the genetic basis of the response to short-term (3 months) orally administered semaglutide treatment, in terms of improving metabolic parameters, including the hormonal response to a standardized meal, and changes in body composition and liver steatosis. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes, Prediabetic State, Obesity
- What is being tested?
- Semaglutide Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2022to 31 Dec 2025
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent was given before any study-related action on the subject.
- Age: 18-65 years old
- Body mass index (BMI) >30 kg/m2 or >27 kg/m2 when accompanied by prediabetes, diagnosed according to the criteria of the American Diabetes Association
Who cannot join
- Patients diagnosed with a serious chronic disease, including:
- Ischemic heart disease
- Heart failure (NYHA class III-IV)
- Severe renal insufficiency (eGFR <30 ml/min)
- Severe liver diseases
- Inflammatory bowel disease
Show all 17Show fewer
- Diabetic gastroparesis
- Cancer - currently or in the last five years prior to screening
- Chronic obstructive pulmonary disease
- History of mental illness, major depression or other severe mental disorders
- Use of any medications with clinically-proven significant weight gain or loss effects
- History of undergoing bariatric surgery or other surgery involving the stomach that could affect the absorption of the study drug (according to the investigator's opinion)
- History of idiopathic acute pancreatitis
- A family or personal history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid cancer
- For women - pregnancy, breastfeeding or planning pregnancy.
- Women of childbearing age who are not using highly effective methods of contraception
- Known or suspected hypersensitivity to the test product
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Clinical Research Centre, Medical University of Bialystok
Bialystok, Podlaskie Voivodeship, 15-276
Lukasz Szczerbinski, MD, PhD, +48 85 831 81 50, lukasz.szczerbinski@umb.edu.pl
Adam Kretowski, MD, PhD
About this study
Official title: Genetics of the Acute Response to Oral Semaglutide (GAROS)
The study aims to investigate the genetic basis of the response to short-term (3 months) orally administered semaglutide treatment, in terms of improving metabolic parameters, including the hormonal response to a standardized meal, and changes in body composition and liver steatosis. In the study, parameters such as fasting and 2-hour glucose during OGTT, HbA1c, body fat mass, body weight, total cholesterol, HDL and LDL, triglycerides, HOMA-IR, Matsuda Index and liver steatosis will be assessed. All the patients will undergo genome-wide genotyping. Moreover, in a subset of participants, muscle and fat biopsies will be performed, before and after the treatment, and liver, muscle and pancreas fat content will be assessed using MRI.
Read the detailed description
Each subject will participate in the following visits:
Visit v1 (screening) - for each patient, fasting venous blood will be collected and an oral glucose tolerance test (OGTT) will be performed - with blood samples taken 30, 60, 90 and 120 minutes after drinking the glucose solution. Fasting blood samples will be used to measure basic metabolic parameters (including glucose, lipid profile, HbA1c, AST, ALT, GGTP, electrolytes, blood count, the presence of antibodies against beta-cell antigens, TSH), and from blood collected at each time point during the OGTT glucose and insulin concentrations will be measured. Each patient will also undergo a detailed body composition analysis using bioimpedance and DXA. In addition, during the visit, each participant will receive a continuous glucose monitoring system (CGM) and an accelerometer to measure physical activity for a period of 10-14 days.
Visit v2 (14-30 days after v1)- during the visit, each patient will undergo a mixed meal tolerance test (MMTT), with blood samples taken 5, 10, 15, 30, 60, 90, 120, 180 minutes after eating the meal, along with a non-invasive measurement of resting energy expenditure (RMR). After the end of the test, the patient will receive semaglutide in two marked doses: 3 mg and 7 mg, along with instructions on how to take them and a diary in which the drug intake and occurrence of side effects will be recorded.
Visit v3 - four weeks after starting the semaglutide treatment. During the visit, fasting venous blood will be collected to measure basic metabolic parameters. Each patient will undergo a detailed body composition analysis using bioimpedance and DXA. During the visit, patients will receive semaglutide in the dose of 14 mg, along with instructions on how to take them and a diary in which the drug intake and occurrence of side effects will be recorded.
Visit v4 - twelve weeks after starting semaglutide treatment. Similar to visit 1 (OGTT).
Visit v5 - twelve weeks after starting semaglutide treatment. Similar to visit 2 (MMTT).
Visit v6 (follow-up visit) - after twelve weeks of ending the semaglutide treatment. Similar to visit 1 (OGTT).
Additionally, a random 20% of the study group will participate in additional visits:
Visit A.1 (between visits v1 and v2), A.2 (+ 1-5 days from visit v5) and A.3 (+ 1-5 days from visit v6) - during the visit, biological material will be collected for each patient in the form of a biopsy of the vastus lateralis muscle and subcutaneous adipose tissue.
Visit B.1 (between visits v1 and v2), B.2 (+ 1-5 days from visit v5) and B.3 (+ 1-5 days from visit v6)- during the visit, patients will undergo an abdominal MRI scan to assess the steatosis of the liver, muscle and pancreas.
- Conditions
- PreDiabetes, Prediabetic State, Obesity
- Being tested
- Semaglutide Pill
- Keywords
- pharmacogenetics, semaglutide, prediabetes, obesity
- Medical subject headings
- Prediabetic State, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide PillDrug
Also called Rybelsus
Oral semaglutide treatment
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide (oral) | Experimental | In this study, each participant will receive a regimen of oral semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, for a duration of twelve weeks. The dosage will begin at 3 mg/day for weeks 1-2, gradually increasing to 7 mg/day for weeks 3-4, 14 mg/day for weeks 5-6, 28 mg/day for weeks 7-8, and finally, to 42 mg/day for the last four weeks (weeks 9-12). Receives: Drug: Semaglutide Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic measures - change in HbA1c (%)
Investigators will measure the change in HbA1c concentration between Visit 2, Visit 3 and Visit 4 as an index of Semaglutide response, and compare them by genotype at selected loci.
Measured: 1 and 3 months
Body composition - change in body weight (kg)
Investigators will measure the change in body weight measures between Visit 2, Visit 3 and Visit 4 as an index of Semaglutide response, and compare them by genotype at selected loci.
Measured: 1 and 3 months
Secondary outcomes (4)
Glycemic measures - change in 2-hour glucose (in mg/dl)
Investigators will measure the change in 2-hour glucose measures (OGTT) between Visit 2, Visit 3 and Visit 4 as an index of Semaglutide response, and compare them by genotype at selected loci.
Measured: 1 and 3 months
Glycemic measures - change in fasting glucose (in mg/dl)
Investigators will measure the change in fasting glucose measures between Visit 2, Visit 3 and Visit 4 as an index of Semaglutide response, and compare them by genotype at selected loci.
Measured: 1 and 3 months
Body composition - change in body fat content (kg)
Investigators will measure the change in body fat content between Visit 2, Visit 3 and Visit 4 as an index of Semaglutide response, and compare them by genotype at selected loci.
Measured: 1 and 3 months
Body composition - change in lean body mass content (kg)
Investigators will measure the change in lean body mass content between Visit 2, Visit 3 and Visit 4 as an index of Semaglutide response, and compare them by genotype at selected loci.
Measured: 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 Sep 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lukasz Szczerbinski, MD, PhD, Principal investigator, Clinical Research Centre, Medical University of Bialystok
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340868
- Sponsor's protocol ID
- APK.002.12.2022
- Acronym
- GAROS
- Status last verified
- Nov 2024
- First submitted
- 1 Apr 2022
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in pharmacogenomics. Data or samples shared will be coded, with no PHI included.
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetics of the Acute Response to Oral Semaglutide (GAROS)
- ClinicalTrials.gov ID
- NCT05340868
- Acronym / sponsor ID
- GAROS / APK.002.12.2022
- Conditions
- PreDiabetes, Prediabetic State, Obesity
- Keywords
- pharmacogenetics, semaglutide, prediabetes, obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Apr 2022 (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.
The study aims to investigate the genetic basis of the response to short-term (3 months) orally administered semaglutide treatment, in terms of improving metabolic parameters, including the hormonal response to a standardized meal, and changes in body composition and liver steatosis. In the study, parameters such as fasting and 2-hour glucose during OGTT, HbA1c, body fat mass, body weight, total cholesterol, HDL and LDL, triglycerides, HOMA-IR, Matsuda Index and liver steatosis will be assessed. All the patients will undergo genome-wide genotyping. Moreover, in a subset of participants, muscle and fat biopsies will be performed, before and after the treatment, and liver, muscle and pancreas fat content will be assessed using MRI.
Detailed description
Each subject will participate in the following visits:
Visit v1 (screening) - for each patient, fasting venous blood will be collected and an oral glucose tolerance test (OGTT) will be performed - with blood samples taken 30, 60, 90 and 120 minutes after drinking the glucose solution. Fasting blood samples will be used to measure basic metabolic parameters (including glucose, lipid profile, HbA1c, AST, ALT, GGTP, electrolytes, blood count, the presence of antibodies against beta-cell antigens, TSH), and from blood collected at each time point during the OGTT glucose and insulin concentrations will be measured. Each patient will also undergo a detailed body composition analysis using bioimpedance and DXA. In addition, during the visit, each participant will receive a continuous glucose monitoring system (CGM) and an accelerometer to measure physical activity for a period of 10-14 days.
Visit v2 (14-30 days after v1)- during the visit, each patient will undergo a mixed meal tolerance test (MMTT), with blood samples taken 5, 10, 15, 30, 60, 90, 120, 180 minutes after eating the meal, along with a non-invasive measurement of resting energy expenditure (RMR). After the end of the test, the patient will receive semaglutide in two marked doses: 3 mg and 7 mg, along with instructions on how to take them and a diary in which the drug intake and occurrence of side effects will be recorded.
Visit v3 - four weeks after starting the semaglutide treatment. During the visit, fasting venous blood will be collected to measure basic metabolic parameters. Each patient will undergo a detailed body composition analysis using bioimpedance and DXA. During the visit, patients will receive semaglutide in the dose of 14 mg, along with instructions on how to take them and a diary in which the drug intake and occurrence of side effects will be recorded.
Visit v4 - twelve weeks after starting semaglutide treatment. Similar to visit 1 (OGTT).
Visit v5 - twelve weeks after starting semaglutide treatment. Similar to visit 2 (MMTT).
Visit v6 (follow-up visit) - after twelve weeks of ending the semaglutide treatment. Similar to visit 1 (OGTT).
Additionally, a random 20% of the study group will participate in additional visits:
Visit A.1 (between visits v1 and v2), A.2 (+ 1-5 days from visit v5) and A.3 (+ 1-5 days from visit v6) - during the visit, biological material will be collected for each patient in the form of a biopsy of the vastus lateralis muscle and subcutaneous adipose tissue.
Visit B.1 (between visits v1 and v2), B.2 (+ 1-5 days from visit v5) and B.3 (+ 1-5 days from visit v6)- during the visit, patients will undergo an abdominal MRI scan to assess the steatosis of the liver, muscle and pancreas.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Semaglutide (oral) | Experimental | Drug: Semaglutide PillIn this study, each participant will receive a regimen of oral semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, for a duration of twelve weeks. The dosage will begin at 3 mg/day for weeks 1-2, gradually increasing to 7 mg/day for weeks 3-4, 14 mg/day for weeks 5-6, 28 mg/day for weeks 7-8, and finally, to 42 mg/day for the last four weeks (weeks 9-12). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed consent was given before any study-related action on the subject.
- Age: 18-65 years old
- Body mass index (BMI) >30 kg/m2 or >27 kg/m2 when accompanied by prediabetes, diagnosed according to the criteria of the American Diabetes Association
Key exclusion criteria (17 listed)
- Patients diagnosed with a serious chronic disease, including:
- Use of any medications with clinically-proven significant weight gain or loss effects
- History of undergoing bariatric surgery or other surgery involving the stomach that could affect the absorption of the study drug (according to the investigator's opinion)
- History of idiopathic acute pancreatitis
- A family or personal history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid cancer
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 |
|---|---|---|
| Semaglutide PillAlso: RybelsusOral semaglutide treatment | Drug | Semaglutide (oral) |
Primary outcome
Glycemic measures - change in HbA1c (%)
Time frame: 1 and 3 months
Investigators will measure the change in HbA1c concentration between Visit 2, Visit 3 and Visit 4 as an index of Semaglutide response, and compare them by genotype at selected loci.
Body composition - change in body weight (kg)
Time frame: 1 and 3 months
Investigators will measure the change in body weight measures between Visit 2, Visit 3 and Visit 4 as an index of Semaglutide response, and compare them by genotype at selected loci.
4 secondary outcomes
Glycemic measures - change in 2-hour glucose (in mg/dl)
Time frame: 1 and 3 months
Glycemic measures - change in fasting glucose (in mg/dl)
Time frame: 1 and 3 months
Body composition - change in body fat content (kg)
Time frame: 1 and 3 months
Body composition - change in lean body mass content (kg)
Time frame: 1 and 3 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 26 Mar 2025.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in pharmacogenomics. Data or samples shared will be coded, with no PHI included.
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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.
Lukasz Szczerbinski, MD, PhD principal investigator
Clinical Research Centre, Medical University of Bialystok
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semaglutide Pill in people with PreDiabetes and Prediabetic State, run by Medical University of Bialystok at 1 site 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 17 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 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Lukasz Szczerbinski, MD, PhD (+48858318150, lukasz.szczerbinski@umb.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic measures - change in HbA1c (%) (time frame: 1 and 3 months). The study lists 2 primary outcomes in all. 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 26 Mar 2025.