Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT05443620
Eligibility Criteria:
Inclusion Criteria:
1. Signed informed consent to participate in the study.
2. Consent out of free will.
3. 18-65 years of age.
4. Maximum body weight of 115 kg.
5. Obesity as defined by a BMI \>30 and ≤35 kg/m2. Fat mass \>25 percent of total body weight.
6. Willingness to comply with the study protocol.
7. Confirmation of adequate function of major organs and systems as judged by investigator
8. Normal or clinically non-significant screening of blood samples:
1. Hemoglobin (Hb), White Blood Cell Count (WBC), thrombocyte count, sodium (Na), potassium (K), chloride (Cl), calcium (Ca), creatinine, aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), glycated hemoglobin (HbA1c), fasting blood glucose, C-reactive protein (CRP), free thyroxine (fT4), thyroid stimulating hormone (TSH), Triglycerides, high-density lipoprotein (HDL), low-density lipoprotein (LDL).
2. Normal or clinically non-significant aberrations of screening blood samples are defined as:
i. Normal: Values within the reference interval supplied by the Turku University Hospital lab.
ii. Clinically non-significant aberration: as judged by investigator (Clinical significance judged by investigator)
Exclusion Criteria:
1. Chronic disease that could interfere with the participation in the study as judged by the investigator such as neurological, renal, hepatic, endocrine, cardiovascular, pulmonary, hematological, or gastrointestinal disorders.
2. Diagnosed diabetes.
3. Chronic pain such as pain that is constant and impairs quality of life as judged by the investigator; for example: significant back, hip or knee pain.
4. Regular consumption of medications or natural supplements that affect weight, inhibit physical activity or increase the risk of adverse effects as judged by the investigator. The following drugs will not be accepted:
a. β-blockers, Glucagon-Like Peptide 1 (GLP-1)-agonists, Dipeptidyl Peptidase-IV (DPP-IV)-inhibitors, Sodium-glucose Cotransporter-2 (SGLT2)-inhibitors, sulfonylureas, insulin, orlistat, anti-obesity drugs, antidepressants, bisphosphonates, β2-agonists, intra articular or parenteral corticosteroids, diuretics, benzodiazepines, or central nervous system stimulating drugs such as methylphenidate or dextroamphetamine.
5. Gastric by-pass surgery or equivalent metabolic surgery in the gastrointestinal tract.
6. Reduced mobility as judged by the investigator.
7. Use of any illegal drugs according to local regulations, use of tobacco or nicotine products (e.g. cigarettes or snuff) or consuming excessive amounts of alcohol.
a. Excessive amounts of alcohol defined as:
i. Consumption of more than 9 glasses of wine for women, 14 glasses of wine for men (15 cl/glass 11 percent alcohol) or equivalent as judged by the investigator during an ordinary week will not be accepted.
8. Change in body weight of ≥5 kg during the last 3 months.
9. Drastic change in lifestyle during the last 3 months including a significant change in physical activity or dietary habits as judged by the investigator.
10. Apparent risk of not being able to comply with the study protocol for any reason as judged by the investigator.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05443620
Study Brief:
Protocol Section:
NCT05443620