NCT07592546RecruitingPhase 4
Translational Health Research Into Vascular and Neurocognitive Effects of Weight Loss
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 3 May 2026
- Start date
- 21 Oct 2026
- Primary completion date
- 1 Dec 2028
- Lead sponsor
- Alain Dagher
- Diseases
- Obesity
- NCT number
- NCT07592546
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 240
- From 21 Oct 2026 to the primary completion date, 1 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
Lab values
- 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.
Other
- Clinical safety blood measures indicative of a medical issue.
Who the study is looking for
- 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
Age in the registry: 35 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Montreal Neurological Institute-Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.