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 @ 1:29 PM
Ignite Modification Date:
2025-12-24 @ 1:29 PM
NCT ID:
NCT03638895
Eligibility Criteria:
Inclusion Criteria:
* BMI \> or equivalent to 30 kg/m2 to - 60 kg/m2
* Stable weight (change of \<5% within 12 weeks before screening based on medical history)
* Subjects are well-motivated, capable and willing to learn how to undergo indirect calorimetry testing
* Willing and able to adhere to prohibitions and restrictions specified within this protocol
For Subjects participating in the glycaemic variability sub-study:
* Subject understands instructions on the use of continuous glucose monitor sensor and is willing to undergo appropriate training and testing
Exclusion Criteria:
* Taking weight loss medication within 12 weeks prior to randomisation
* Previous or planned bariatric surgery
* History of Type 1, Type 2 diabetes mellitus, DKA or diabetes secondary to pancreatitis
* Has HbA1c \> or equal to 6.5% or Fasting Plasma Glucose \> or equal to 7.0 mmol/L at screening.
NOTE: a one-time repeat measurement is allowed, if value of HbA1c and/or FPG is not consistent with prior values
* History of obesity with a known secondary cause (Cushing's disease/syndrome)
* Oral corticosteroid use (except in the short term use of a 7-10 day course)
* Ongoing, inadequately controlled thyroid disorder defined as thyroid-stimulating hormone \> 6 mIU/litre or \< 0.4 mIU/litre
* History of malignancy within 3 years before screening (or diagnosis of malignancy within this period)
* estimated glomerular filtration rate \< 30 ml/min/1.73m2 on serum testing
* Alanine aminotransferase level is \<2.0 times the upper limit of normal or total bilirubin is \>1.5 times the upper limit of normal at screening
* Other major illness likely to preclude participation in the trial
* History of glucagonoma
* A myocardial infarction, unstable angina, revascularisation procedure (stent or bypass graft surgery) or cerebrovascular accident within 12 weeks before screening
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03638895
Study Brief:
Protocol Section:
NCT03638895