Semaglutide and Brain Health in Adults With Excess Body Fat
Tests semaglutide and weight loss's effect on brain scans in adults with obesity.
Key facts
- Who runs it
- Alain Dagher
- Where
- Montreal, CanadaSee the site
- Trial code
- Registry title
- Translational Health Research Into Vascular and Neurocognitive Effects of Weight Loss
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 240 people, planned
- Started
- 21 Oct 2026
- Expected to end
- 1 Jun 2030
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- semaglutide
- Record updated
- 26 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 35-55, either with a BMI of 27 - 40 kg/m2 who will take weekly semaglutide, or lean people with a BMI of 20 - 25 kg/m2 as a control group.
- Age
- 35 to 55 years
- Sex
- All sexes can join
- Disease stage
- Excess body weight (BMI 27 - 40 kg/m2) for the obese group; BMI 20 - 25 kg/m2 for the lean control group
- Earlier treatment
- No other weight loss medication within 90 days before enrolment and during the trial; no previous or planned bariatric surgery
Main reasons for not taking part
- Current type 2 diabetes
- Neurological disorders affecting the CNS
- History or family history of medullary thyroid carcinoma or MEN2 syndrome
- History of pancreatitis
- Weight change of more than 5 kg (11 lb) in the past 90 days
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
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?
Where in Canada
- The Montreal Neurological Institute-HospitalMontreal, CanadaContact: Alain Dagher, MD (principal investigator)Taking people
About the trial
What the trial wants to find out
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
* 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
The 2 groups in the trial
- Overweight Group (BMI 27 - 40 kg/m2)Treatment being tested
semaglutide
Treatment: semaglutide
- Lean group (BMI 20 - 25 kg/m2)No study treatment, for comparison
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Translational Health Research Into Vascular and Neurocognitive Effects of Weight Loss
- Plain-language title
- Semaglutide and Brain Health in Adults With Excess Body FatGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07592546, who can take part
- Record updated
- 26 October 2026