Brain Plasticity and GLP-1 Receptor Agonist Treatment for Obesity

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT07021937
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Obesity/Therapy

Eligibility Criteria

Sex
ALL
Age
12 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide 1.7mg subcutaneous — DRUG
    Semaglutide subcutaneous max dose of 1.7mg over 24 or 32 weeks of active treatment
  • Placebo — DRUG
    Placebo saline solution subcutaneous

Study Details

Glucagon-like peptide 1 receptor agonists (GLP-1RA), such as Ozempic and Wegovy, have been rapidly adopted for the treatment of obesity in both youth and adults. However, despite this rapid adoption and the known GLP-1RA mechanism of action for weight loss, which targets brain circuits responsible for appetite and eating behaviors, almost nothing is known about how these drugs affect the brain in youth who are treated for obesity, or how these drugs affect the brain of youth differently from adults. The goal of the current study is to compare youth and adults with obesity who are treated a GLP-1RA and measure potential difference in GLP-1RA associated change in brain function, appetite, and eating behaviors.

Key Dates

Start date
May 1, 2026
Status verified
Jun 2025
Primary completion
Apr 30, 2031
Completion
Apr 30, 2031

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pubertal Adolescent - Continuous Treatment
    Pubertal adolescents defined as Tanner stage 2-4 and/or 12-15 y/o who will receive 32 weeks of semaglutide (s.c.)
  • Experimental: Pubertal Adolescent - Early Treatment Cessation
    Pubertal adolescents defined as Tanner stage 2-4 and/or 12-15 y/o who will receive 24 weeks of semaglutide (s.c.) followed by 8 weeks of placebo
  • Experimental: Post-Pubertal Adolescent - Continuous Treatment
    Post-pubertal adolescents defined as Tanner stage 5 and/or 16-18 y/o who will receive 32 weeks of semaglutide (s.c.)
  • Experimental: Post-Pubertal Adolescent - Early Treatment Cessation
    Post-pubertal adolescents defined as Tanner stage 5 and/or 16-18 y/o who will receive 24 weeks of semaglutide (s.c.) followed by 8 weeks of placebo
  • Active Comparator: Adult - Continuous Treatment
    Adults defined as 30-45 y/o who will receive 32 weeks of semaglutide (s.c.)
  • Active Comparator: Adult - Early Treatment Cessation
    Adults defined as 30-45 y/o who will receive 24 weeks of semaglutide (s.c.) followed by 8 weeks of placebo

Primary Outcome Measure

hypothalamic functional activation [ Time Frame: From enrollment to the end of trial at 32 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado Anschutz Medical CampusAuroraColorado80045
Allison Shapiro, PhD, MPH
[email protected]
3037243733
Allison Shapiro, PhD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
University of Colorado Anschutz Medical Campus· Aurora, CO

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