Translational Health Research Into Vascular and Neurocognitive Effects of Weight Loss

Starting soon · Phase 4

Conditions studied: Class I/II Obesity

In brief

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

Key facts

Study ID

NCT07592546

Run by

Alain Dagher

People needed

240

Starts

2026-08-01

Expected to finish

2030-06-01

Last updated by the study team

2026-06-26

Who can join

Age: 35 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

Where it is running

• The Montreal Neurological Institute-Hospital — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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