Semaglutide and Brain Health in Adults With Excess Body Fat
Tests semaglutide and weight loss's effect on brain scans in adults with obesity.
Plain-language title generated from the registry record
Registry title: Translational Health Research Into Vascular and Neurocognitive Effects of Weight Loss
Key facts
- Where
- Montreal, CanadaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 35 and 55 years old?
Source: NCT07592546, who can take part
Where in Canada
- The Montreal Neurological Institute-HospitalMontreal, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Alain Dagher
- Trial code
- NCT07592546
- Record updated
- 26 October 2026
- Original description
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:Read full original descriptionShow less
Translational Health Research Into Vascular and Neurocognitive Effects of Weight Loss
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
Inclusion: 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; Individuals of age 35-55 years with BMI 20 - 25 kg/m2; Able to provide informed consent.
Exclusion: 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; Previous or planned bariatric surgery; Use of another weight loss medication during trial participation and within 90 days before enrolment; 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; 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); History of weight change > 5 kg in past 90 days; History of pancreatitis; 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; Clinical safety blood measures indicative of a medical issue.