ClinicalTrials.gg
Not yet recruitingNCT07021937PLASTICUpdated Jul 2, 2026

Brain Plasticity and GLP-1 Receptor Agonist Treatment for Obesity

A Phase 3 interventional study of Semaglutide 1.7mg subcutaneous and Placebo in Obesity/Therapy, sponsored by University of Colorado, Denver. Not yet recruiting at 1 site in United States. Open to participants aged 12 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-07-02.

Sponsored by University of Colorado, Denver · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
12 Years to 45 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 143 studies testing semaglutide in Obesity — 68 open to participants now, 77 under way, 14 of them phase 3. Semaglutide · Obesity.

Planned enrollment
58th of 143
120 · median 100
Started
2026
with 29 others
Phase 3
42 of 143
10 open now
Primary completion
2031-04
later than 75 of 76 live
Registered
101st of 143
by date
Lead sponsor
4 of 143
University of Colorado, Denver

Among the 143 studies testing semaglutide in Obesity, this one is the 58th largest by planned enrollment, is one of 30 that started in 2026, is one of 42 in phase 3, reaches primary completion later than 75 of the 76 other live ones, and was the 101st registered.

How this study gives semaglutide

On this site’s reading of the record, semaglutide is the treatment under test here. Read study by study →

By phase

143 studies; the count open now beside each. This study's row is marked.

Phase 3this study42 · 10 open
Phase 440 · 20 open
Phase 119 · 9 open
No phase18 · 14 open
Phase 216 · 9 open
Phase 1/24 · 4 open
Phase 2/34 · 2 open

By the year they started

First in 2014; this study’s year is marked. 30 started in 2026.

Size and results

Median enrollment 100 across the 143 interventional studies. Of the 60 that completed or were terminated, 35 (58%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 143 studies testing semaglutide in Obesity, or all of them as a file.
02

Study summary

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.

03

Conditions studied

  • Obesity/Therapy

Keywords

  • adolescent
  • adult
  • brain function
  • glucagon-like peptide-1 receptor agonists
  • eating behaviors
  • appetite sensations
04

Who can participate

Ages eligible
12 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • English-speaking
  • male or female (sex assigned at birth)
  • 12-18 y/o with obesity (>120% of the 95th %ile)
  • 30-45 y/o with obesity (BMI>35 kg/m2)

Exclusion criteria

Exclusion Criteria:

  • treated with glucagon-like peptide-1 (GLP-1) agonists (e.g., exenatide, liraglutide, semaglutide, tirzepatide) for weight management in the prior 3 months
  • currently taking anti-psychotic medications (anti-depressants accepted)
  • diagnosis of type 2 diabetes
  • current or lifetime anorexia nervosa or current bulimia nervosa
  • head injury resulting in loss of consciousness >30min
  • neurological disorder (e.g., Parkinson's disease) or history of stroke
  • any to receiving a MRI (e.g., orthodontal braces)
  • psychological/behavioral dysfunction (e.g., autism spectrum disorder) or physical impairment that would interfere with study procedures, as determined by study physician
  • if female, desiring to become pregnant, or currently pregnant or breastfeeding
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
120 participants (estimated)

Study 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.)

    Drug: Semaglutide 1.7mg subcutaneous

  • 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

    Drug: Semaglutide 1.7mg subcutaneous · Drug: 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.)

    Drug: Semaglutide 1.7mg subcutaneous

  • 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

    Drug: Semaglutide 1.7mg subcutaneous · Drug: Placebo

  • Active comparator
    Adult - Continuous Treatment

    Adults defined as 30-45 y/o who will receive 32 weeks of semaglutide (s.c.)

    Drug: Semaglutide 1.7mg subcutaneous

  • 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

    Drug: Semaglutide 1.7mg subcutaneous · Drug: Placebo

Interventions

  • Semaglutide subcutaneous max dose of 1.7mg over 24 or 32 weeks of active treatment

    Also known as: SEMA

  • DrugPlacebo

    Placebo saline solution subcutaneous

06

What researchers measure

Primary outcomes

  1. blood oxygen-level dependent signal

    measured via resting-state functional magnetic resonance imaging

    Time frame: From enrollment to the end of trial at 32 weeks

  2. meal kilocalories (kcal)

    Measured as kcal consumed from standardized ad libitum meal

    Time frame: From enrollment to the end of trial at 32 weeks

  3. visual analogue scale (VAS) score for hunger

    pre- and post-meal hunger measured on a 100mm VAS

    Time frame: From enrollment to the end of trial at 32 weeks

  4. visual analogue scale (VAS) for desire to eat

    pre- and post-meal desire to eat measured on a 100mm VAS

    Time frame: From enrollment to end of trial at 32 weeks

  5. visual analogue scale (VAS) score for fullness

    pre- and post-meal feeling of fullness measured on a 100mm VAS

    Time frame: From enrollment to end of trial at 32 weeks

  6. visual analogue scale (VAS) score for amount participant feels they can eat

    pre- and post-meal of amount participant feels they can eat measured on a 100mm VAS

    Time frame: From enrollment to end of trial at 32 weeks

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — Pending consent authorization by participants

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07021937
Collaborators
University of Minnesota, The Metis Foundation
Responsible party
Sponsor
First posted
Jun 15, 2025
Start date
Jun 15, 2026 (estimated)
Primary completion
Apr 30, 2031 (estimated)
Completion
Apr 30, 2031 (estimated)
Last update
Jul 2, 2026

Study contacts

Allison Shapiro, PhD, MPH
Contact
allison.shapiro@cuanschutz.edu
3037241150
Allison Shapiro, PhD, MPH
principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Semaglutide

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