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:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2025-12-24 @ 12:34 PM
NCT ID:
NCT06616961
Eligibility Criteria:
Inclusion Criteria:
-Common inclusion criteria for both diabetic and non-diabetic individuals
* Informed consent will be obtained before any trial-related activities
* Male or female, aged ≥ 18 years at the time of signing the informed consent form
* Body mass index (BMI) ≥30 kg/m2 with or without any weight-related comorbidities or ≥25-29.9 kg/m2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease (more than three months) For subjects with T2DM
* Patients diagnosed with T2DM more than or equal to 180 days prior to the day of screening.
* HbA1c up to 12.0%
Exclusion Criteria:
* Common exclusion criteria for both diabetic and non-diabetic individuals Medical criteria
* A self-reported reduction in body weight of more than 5 kg within 30 days before screening, irrespective of medical records
* Treatment with any medication for the indication of obesity within the past 90 days before screening (eg. Orlistat, liraglutide, naltrexone/bupropion, diethylpropion, phendimetrazine, and Setmelanotide etc.)
* Any previous obesity treatment with surgery or a weight loss device during lifetime
* Continued treatment with other GLP-1 agonists, SGLT-2 inhibitor and/or metformin. However, if these drugs can be stopped based on the best clinical judgement of the investigator, the patient can be recruited after stopping the drug and a washout period of two weeks. In case of semaglutide (ORSEMA) the wash out period will be 10 weeks.
* Patient taking oral or injectable steroid for other indications
* Past history of pancreatitis
* Diagnosed case of eating disorders eg. Bulimia nervosa
* Patients with a previous history of suicide attempts and major depressive disorder (MDD) according to the DSM-V criteria, schizophrenia or anti-psychotic drug induced obesity
* Patients with a personal or family history of medullary thyroid carcinoma (MTC) and/or multiple endocrine neoplasia syndrome type 2 (MEN 2)
* Known hypersensitivity to Semaglutide or any of the product components.
* History of recent MI (within past three months)
* Pregnancy and lactation Laboratory criteria
* Incidental diagnosis or Uncontrolled thyroid disease, defined as a thyroid stimulating hormone (TSH) level \> 6.0 mIU/L or \<0.4 mIU/L as measured by the central laboratory at screening. However, well-controlled thyroid disorder can be included if TSH\<6.0 or \>0.4 mIU/L.
* Renal impairment, measured as the estimated glomerular filtration rate (eGFR) \<15 ml/min/1.73 m2 For subjects without T2DM
* HbA1c more than or equal to 48 mmol/mol (6.5%) For subjects with T2DM
* Renal impairment, defined as an estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m2 (less than 60 mL/min/1.73 m2 in subjects treated with a sodium-glucose cotransporter 2 inhibitor (SGLT2i)).
* Uncontrolled T2DM (HbA1c \>12.0%) as these patients may require insulin or other anti-diabetic drug which might potentially interfere the efficacy of semaglutide
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06616961
Study Brief:
Protocol Section:
NCT06616961