Brain Plasticity and GLP-1 Receptor Agonist Treatment for Obesity (PLASTIC)

University of Colorado Denver (CU Denver)

Status and phase: Begins enrollment in 2 months; Phase 3

Conditions: Obesity/Therapy

Treatments: Drug: Placebo; Drug: Semaglutide 1.7mg subcutaneous

Study type: Interventional

Funder types: Other

Identifiers

NCT07021937

Pending

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 12 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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 contraindication 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 6 patient groups

Pubertal Adolescent - Continuous Treatment

Experimental group

Description:

Pubertal adolescents defined as Tanner stage 2-4 and/or 12-15 y/o who will receive 32 weeks of semaglutide (s.c.)

Treatment:

Drug: Semaglutide 1.7mg subcutaneous

Pubertal Adolescent - Early Treatment Cessation

Experimental group

Description:

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

Treatment:

Drug: Semaglutide 1.7mg subcutaneous

Drug: Placebo

Post-Pubertal Adolescent - Continuous Treatment

Experimental group

Description:

Post-pubertal adolescents defined as Tanner stage 5 and/or 16-18 y/o who will receive 32 weeks of semaglutide (s.c.)

Treatment:

Drug: Semaglutide 1.7mg subcutaneous

Post-Pubertal Adolescent - Early Treatment Cessation

Experimental group

Description:

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

Treatment:

Drug: Semaglutide 1.7mg subcutaneous

Drug: Placebo

Adult - Continuous Treatment

Active Comparator group

Description:

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

Treatment:

Drug: Semaglutide 1.7mg subcutaneous

Adult - Early Treatment Cessation

Active Comparator group

Description:

Adults defined as 30-45 y/o who will receive 24 weeks of semaglutide (s.c.) followed by 8 weeks of placebo

Treatment:

Drug: Semaglutide 1.7mg subcutaneous

Drug: Placebo