Semaglutide for Obesity

(PLASTIC Trial)

Overseen By Allison Shapiro, PhD, MPH

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Colorado, Denver

Must not be taking: Antipsychotics

Disqualifiers: Type 2 diabetes, Anorexia, Bulimia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 32 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how the medication semaglutide affects brain function, appetite, and eating behaviors in people with obesity. Researchers aim to determine if these effects differ between adolescents and adults. The study includes different groups receiving semaglutide for various durations, with some also receiving a placebo. It suits English-speaking individuals aged 12-18 or 30-45 who have been managing obesity. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking anti-psychotic medications or have used certain weight management drugs in the past 3 months.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that semaglutide, the treatment under study, is generally safe and well-tolerated. A review found that semaglutide led to significant weight loss in adults without major safety issues. About 33.4% of people taking semaglutide lost at least 20% of their weight, compared to just 2.2% of those taking a placebo. This suggests that the treatment is effective and does not cause serious side effects for most people.

Another study found that when combined with lifestyle changes, semaglutide helped people lose significant weight over time. This was consistent across different groups, regardless of age or other factors. The findings suggest that semaglutide is safe for long-term use in adults seeking weight loss.

While these studies focus on adults, they provide a good indication of the treatment's safety. However, this trial aims to assess how semaglutide affects younger people. It is important to note that the FDA has already approved semaglutide for weight loss, which adds confidence in its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obesity?

Researchers are excited about semaglutide for obesity because it offers a novel approach to weight management by mimicking a hormone called GLP-1, which helps regulate appetite and food intake. Unlike traditional treatments that might focus on diet and exercise alone, semaglutide directly targets the brain's appetite control centers, potentially leading to more effective weight loss. Additionally, semaglutide is administered through a convenient once-weekly injection, which might improve adherence compared to daily medications. This combination of a unique mechanism of action and ease of use makes semaglutide a promising option for tackling obesity.

What evidence suggests that semaglutide might be an effective treatment for obesity?

Research has shown that semaglutide, a type of medication, is effective for weight loss. In one study, about 30% of adults taking Wegovy (the brand name for semaglutide) lost 20% or more of their body weight, compared to only 2% of those taking a placebo. Another study found that semaglutide, when combined with lifestyle changes, led to significant weight loss over time. Additionally, semaglutide was linked to a 20% reduction in major heart-related health issues, which is a significant benefit. These findings suggest that semaglutide could be a promising option for managing obesity. Participants in this trial will receive semaglutide in different treatment arms, including continuous treatment and early treatment cessation, to evaluate its effectiveness across various age groups and treatment durations. ^{4 5 6 7 8}

Who Is on the Research Team?

Allison Shapiro, PhD, MPH

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for young and adult individuals with obesity, focusing on how a GLP-1 receptor agonist treatment affects their brain function related to appetite and eating behaviors. Specific eligibility criteria are not provided.

Inclusion Criteria

I am between 12 and 18 years old and have obesity.

English-speaking

I am either male or female as per my birth sex.

Exclusion Criteria

I have had a head injury that made me unconscious for more than 30 minutes.

I am currently on anti-psychotic medication.

Current or lifetime anorexia nervosa or current bulimia nervosa

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive semaglutide for 24 to 32 weeks, with some groups transitioning to placebo for the final 8 weeks

32 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Semaglutide

Trial Overview The study tests the effects of Semaglutide, a medication used for weight loss that targets brain circuits controlling appetite, against a placebo. It aims to understand differences in drug impact between youth and adults with obesity.

How Is the Trial Designed?

Group I: Pubertal Adolescent - Early Treatment Cessation Experimental Treatment 2 Interventions

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

Group II: Pubertal Adolescent - Continuous Treatment Experimental Treatment 1 Intervention

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

Group III: Post-Pubertal Adolescent - Early Treatment Cessation Experimental Treatment 2 Interventions

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

Group IV: Post-Pubertal Adolescent - Continuous Treatment Experimental Treatment 1 Intervention

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

Group V: Adult - Continuous Treatment Active Control 1 Intervention

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

Group VI: Adult - Early Treatment Cessation Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

The Metis Foundation

Collaborator

Trials

13

Recruited

750+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40768192/

Real-World Weight Loss Among Patients Initiating ... The proportions of patients achieving ≥ 20% weight loss were 13.1%, 43.3%, 52.5%, and 50.5% at 6, 12, 18, and 24 months, respectively. Similar ...

2. nature.com nature.com/articles/s41591-024-02996-7

Long-term weight loss effects of semaglutide in obesity ... In the SELECT cardiovascular outcomes trial, semaglutide showed a 20% reduction in major adverse cardiovascular events in 17,604 adults with ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa2032183

Once-Weekly Semaglutide in Adults with Overweight or ... 2.4 mg of semaglutide once weekly plus lifestyle intervention was associated with sustained, clinically relevant reduction in body weight.

4. vox.com vox.com/future-perfect/467025/ozempic-glp-1-drugs-obesity-weight-loss

The Ozempic effect is finally showing up in obesity data - Vox ... Ozempic — produced about 15 percent average weight loss over 68 weeks when paired with basic lifestyle support. Other combinations have ...

5. wegovy.com wegovy.com/about-wegovy/managing-weight-with-wegovy.html

Managing Weight with Wegovy 30% of adults (about 1 in 3) taking Wegovy® lost 20% or more weight compared with 2% of adults on placebo. This result was not the primary goal of the study and ...

6. fda.gov fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss

FDA's Concerns with Unapproved GLP-1 Drugs Used for ... FDA is aware of fraudulent compounded semaglutide and tirzepatide marketed in the U.S. that contain false information on the product label. In ...

7. novomedlink.com novomedlink.com/obesity/products/treatments/wegovy/efficacy-safety/safety-profile.html

Wegovy® Safety Profile Learn about the safety profile of Wegovy® after being evaluated in clinical studies. Read Important Safety and Prescribing Info, including Boxed Warning.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38679221/

A Systematic Review and Meta-Analysis of Randomized ... At the longest follow-up, 33.4% of participants randomized to semaglutide achieved ≥20% weight loss compared with 2.2% with placebo (RR 15.08, ...