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:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-26 @ 11:09 AM
NCT ID:
NCT05111912
Eligibility Criteria:
Inclusion Criteria:
To be eligible for this study, a participant has to meet all of the following inclusion criteria:
1. Male or female, aged 18 to 70 years (inclusive at the time of informed consent);
2. Participants must have a BMI ≥ 30.0 kg/m2 and ≤40.0 kg/m2 at Screening;
3. Participants must have a stable body weight for at least 3 months prior to Screening (\<5% change, self-reported);
4. Participants must have glycated haemoglobin (HbA1c) level \<6.5% at Screening;
5. Women of childbearing potential (WOCBP) must be non-pregnant and must use an acceptable, highly effective contraception from Screening until the study completion, including the follow-up period.
6. Participants must have the ability and willingness to attend the necessary visits to the clinical research unit (CRU);
7. Participants must be willing and able to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.
Exclusion Criteria:
A participant who meets any of the following exclusion criteria must be excluded from the study:
1. Diagnosis of type 2 (HbA1c ≥6.5%) or other types of diabetes mellitus;
2. Obesity induced by endocrine disorders (e.g., Cushing syndrome);
3. Calcitonin ≥50 ng/L (pg/mL) at Screening;
4. History of severe allergic or hypersensitivity to any of the investigational products or its excipients or to drugs of similar chemical classes;
5. History of cerebral stroke (including but not limited to cerebral infarction/haemorrhage) within 6 months prior to Screening;
6. History of acute coronary syndrome (angina pectoris and/or myocardial infarction) and any other major cardiac conditions (including but not limited to myocarditis, cardiac insufficiency/failure, and any clinically significant arrythmia\[s\]) within 6 months prior to Screening;
7. Impaired liver function defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>5 times upper limit of normal (ULN) at Screening;
Main Inclusion Criteria:
To be eligible for this study, a participant has to meet all of the following inclusion criteria:
1. Male or female, aged 18 to 70 years (inclusive at the time of informed consent);
2. Participants must have a BMI ≥ 30.0 kg/m2 and ≤40.0 kg/m2 at Screening;
3. Participants must have stable body weight for at least 3 months prior to Screening (\<5% change, self-reported);
4. Participants must have glycated hemoglobin (HbA1c) level \<6.5% at Screening;
5. Women of childbearing potential (WOCBP) must be non-pregnant and must use an acceptable, highly effective contraception from Screening until the study completion, including the follow-up period.
6. Participants must have the ability and willingness to attend the necessary visits to the clinical research unit (CRU);
7. Participants must be willing and able to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.
Main Exclusion Criteria:
A participant who meets any of the following exclusion criteria must be excluded from the study:
1. Diagnosis of type 2 (HbA1c ≥6.5%) or other types of diabetes mellitus;
2. Obesity induced by endocrine disorders (e.g., Cushing syndrome);
3. Calcitonin ≥50 ng/L (pg/mL) at Screening;
4. History of severe allergic or hypersensitivity to any of the investigational products or its excipients or to drugs of similar chemical classes;
5. History of cerebral stroke (including but not limited to cerebral infarction/haemorrhage) within 6 months prior to Screening;
6. History of acute coronary syndrome (angina pectoris and/or myocardial infarction) and any other major cardiac conditions (including but not limited to myocarditis, cardiac insufficiency/failure, and any clinically significant arrythmia\[s\]) within 6 months prior to Screening;
7. Impaired liver function defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>5 times upper limit of normal (ULN) at Screening;
8. Estimated glomerular filtration rate (eGFR), calculated using the modified diet in renal disease (MDRD) formula \< 60 mL/min/1.73m2;
9. History of acute or chronic pancreatitis or defined as amylase \>ULN at Screening;
10. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2);
11. Positive infection with human immunodeficient virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV);
12. History of primary or recurrent malignancy, except for non-melanoma skin cancer excised more than 2 years prior to Screening;
13. History of clinically significant endocrine condition(s);
14. History of major depressive disorder within 2 years before randomisation;
15. History of surgical treatment for obesity;
16. Having been exposed to any GLP-1 analogues within 6 months before Screening;
17. Treatment with orlistat, zonisamide, topiramate, phentermine, lorcaserin, bupropion and naltrexone alone or in combination or any other medications that could promote weight loss within 90 days prior to Screening;
18. Use of any other investigational products or medical devices within 3 months prior to Screening;
19. Participation in any medical (e.g., assisted by a clinical dietician or nutritionist) or non-medical (e.g., by a gym coach) diet and/or exercise program within 3 months prior to Screening and for the duration of the study (including the follow-up period);
20. Known or suspected abuse of alcohol or recreational drugs;
21. Being pregnant or lactating at Screening or planning to become pregnant (self or female partner) at any time during the study and for at least 3 months after the last dose of study drug;
22. Presence of any underlying physical and/or psychological medical condition that, in the opinion of the investigator, would make it unlikely that the participant will comply with the protocol or complete the study per protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05111912
Study Brief:
Protocol Section:
NCT05111912