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 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT05215418
Eligibility Criteria:
Inclusion Criteria:
* Overweight/obese adult males/females 18-75 years of age with a BMI ≥ 27 kg/m2;
* At least 1 weight-related comorbidity (i.e., hypertension, dyslipidemia, Type 2 diabetes mellitus \[T2DM\] or prediabetes, or obstructive sleep apnea).
* Must be ambulatory, willing, and able to wear ABPM monitor apparatus for 24 hours at beginning and end of study.
Exclusion Criteria:
* Screening blood pressure of \> 140/90 mmHg;
* Type 1 diabetes; T2DM treated with SFUs, GLP-1 receptor agonists, SGLT inhibitors; or not on stable diabetic medications for at least 3 months prior to randomization;
* Clinically significant cardiac, hepatic, renal, pulmonary, or thyroid disease;
* History of bipolar disorder, psychosis, greater than one lifetime episode of major depressive disorder, or presence or history of suicidal behavior or suicidal ideation with intent to act;
* History of glaucoma;
* Night shift workers;
* Obesity of known genetic or endocrine origin; recent history of weight instability, or recent participation in a formal weight loss program within 3 months prior to screening; and
* Smoking cessation within 3 months prior to screening;
* Use of antihypertensive medications, antidiabetic medications, statins or other lipid lowering agents, or CPAP therapy that has not been stable for at least 3 months prior to randomization;
* COVID-19 vaccination or treatment for severe COVID-19 infection within a month prior to randomization.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05215418
Study Brief:
Protocol Section:
NCT05215418