Translational Health Research Into Vascular and Neurocognitive Effects of Weight Loss

Sponsor
Alain Dagher
Study ID
NCT07592546
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Class I/II Obesity

Eligibility Criteria

Sex
ALL
Age
35 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • semaglutide — DRUG
    Treatment will be given for 80 weeks. Dose will be escalated from 0.25 mg to a max of 2.4 mg per week.

Study Details

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 Dates

Start date
Aug 1, 2026
Status verified
May 2026
Primary completion
Dec 1, 2028
Completion
Jun 1, 2030

Study Design

Enrollment
240 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Overweight Group (BMI 27 - 40 kg/m2)
    semaglutide
  • No Intervention: Lean group (BMI 20 - 25 kg/m2)

Primary Outcome Measure

Serum C-reactive Protein (CRP) [ Time Frame: Baseline & Change from Baseline ]

Central Contacts