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 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT04251156
Eligibility Criteria:
Inclusion Criteria:
* Male or female, age 18 years or older at the time of signing informed consent
* History of at least one self-reported unsuccessful dietary effort to lose body weight
For subjects without T2D at screening:
* Body mass index (BMI) of :
* greater than or equal to 30 kg/m\^2
* greater than or equal to 27 kg/m\^2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
For subjects with T2D at screening:
* Diagnosed with T2D above or equal to 180 days prior to the day of screening
* Treated with either:
* diet and exercise alone or
* stable treatment (same drug(s), dose and dosing frequency) for at least 60 days prior to the day of screening with up to 3 oral antidiabetic medications alone or in any combination (metformin, α-glucosidase inhibitor (AGI), SU, glinides, SGLT2i or glitazone) according to local label
* HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive)
* BMI greater than or equal to 27 kg/m\^2
Exclusion Criteria:
* A self-reported change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records
For subjects without T2D at screening:
\- HbA1c equal to or above 6.5% (48 mmol/mol) as measured by the central laboratory at screening
For subjects with T2D at screening :
* Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of below 30 mL/min/1.73 m\^2 (below 60 mL/min/1.73 m\^2 in subjects treated with SGLT2i) according to CKDEPI creatinine equation as defined by KDIGO 2012 by the central laboratory at screening
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04251156
Study Brief:
Protocol Section:
NCT04251156