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Obesity drug semaglutide tested for brain benefits in new trial

NCT ID NCT07592546

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 4 trial will study 240 adults aged 35-55 with class I/II obesity to see if weight loss from semaglutide (Ozempic/Wegovy) improves brain health. Participants will take the drug weekly for 80 weeks and undergo MRI scans, cognitive tests, and blood work. The study also includes a lean control group for comparison. The goal is to understand how excess body fat affects the brain and whether weight loss can reverse any abnormalities.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
semaglutide (Ozempic, Wegovy)
What this could lead to
If successful, this could show that weight loss with semaglutide improves brain structure and function, pointing toward a way to protect brain health in people with obesity.
What could go wrong
This is an early-phase study focused on measuring changes, not proving clinical benefit. The results may not apply to everyone, and semaglutide can cause side effects like nausea and vomiting.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

35 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight Weight Loss

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Montreal Neurological Institute-Hospital

    Montreal, Quebec, H3A 2B4, Canada