Weight loss and brain health in adults with obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial investigates brain changes linked to excess body fat and whether weight reduction with semaglutide can modify MRI-detected brain health in adults aged 35-55. Participants with obesity and lean controls will undergo weekly self-administered semaglutide or no treatment, with extensive MRI imaging, cognitive and mood assessments, and lifestyle questionnaires over 80 weeks. The study is powered to detect small to medium brain-health effects and will stratify analyses by sex. Primary outcomes focus on MRI biomarkers of brain structure and function, while secondary measures include metabolic, cognitive, and mood data. The Montreal Neurological Institute-Hospital serves as the trial site under lead sponsor Alain Dagher.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Michael Pileggi, M.Sc.
• Email: michael.pileggi@mcgill.ca
• Phone: 514-396-2085

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.