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NCT07592546
Translational Health Research Into Vascular and Neurocognitive Effects of Weight Loss
Conditions: Class I/II Obesity
Sex: All
Ages: 35 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE4
Enrollment: 240
Sponsor: Alain Dagher
Location: The Montreal Neurological Institute-Hospital Montreal Quebec
Summary
The goal of this clinical trial is to learn about the nature of brain abnormalities associated with excess body fat in healthy adults aged 35-55. The main questions it aims to answer are:
* Will excessive fat be associated with brain abnormalities on MRI measures?
* Will weight loss change brain health on MRI measures?
Participants will:
* Self-administer study drug, semaglutide, once a week for 80 weeks
* Complete metabolic and basic body measurements
* Complete cognitive, mood, and dietary assessments
* Complete questionnaires
* Undergo MRIs
Eligibility Criteria
Inclusion Criteria:
Key inclusion criteria for obese group:
* Individuals of age 35-55 years with BMI 27 - 40 kg/m2
* Able to provide informed consent
* Willing to self-inject semaglutide and follow study procedures for its entire duration.
Key inclusion criteria for lean control group:
* Individuals of age 35-55 years with BMI 20 - 25 kg/m2
* Able to provide informed consent
Exclusion Criteria for both groups:
* Current type 2 diabetes mellitus;
* Neurological disorders affecting the CNS;
* History or family history of medullary thyroid carcinoma or MEN2 syndrome
* CNS-active medications (outside of medications used to control psychiatric disorders);
* Poorly controlled psychiatric disorders including major depression or previous suicidality;
* Class III obesity (BMI\>40 or BMI\>35 with complications) as these individuals are eligible for bariatric surgery in Canada and will be referred for appropriate medical care;
* Clinical safety blood measures indicative of a medical issue.
* History of weight change \> 5 kg in past 90 days;
* History of pancreatitis
* Previous or planned bariatric surgery;
* Use of another weight loss medication during trial participation and within 90 days before enrolment;
* History of serious medical illness, monogenic obesity, uncontrolled hypertension (sBP\>160 mmHg, dBP\>100 mmHg), active malignancy, illicit substance use, cigarette smoking, diagnosed eating disorder, as listed in the study protocol associated with; Other obesity comorbidities, e.g. hypertension, pre-diabetes (HbA1C = 6% to 6.4%), hyperlipidemia, controlled depressive disorder or anxiety, ADHD, and polycystic ovary syndrome, will not be exclusion criteria as this would reduce the representativeness of our sample.
* Female subjects of childbearing potential (i.e., a premenopausal female capable of becoming pregnant) are eligible to enroll if they are either sexually inactive/abstinent or using an effective contraceptive from screening until 4 weeks after the last dose. Medically accepted contraception are hormonal implants, hormonal patches, IDU, diaphragm and spermicide, cervical cape with spermicide, and condom with spermicide.
Source: ClinicalTrials.gov (NCT07592546). StuddyBuddy aggregates publicly available trial information.