Semaglutide for Childhood Obesity

Overseen By Alaina P Vidmar, MD

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Children's Hospital Los Angeles

Must be taking: Semaglutide

Must not be taking: Prednisone

Disqualifiers: Type 1 diabetes, Cushing, 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: 3

Duration: 24 months

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a Phase 3a, randomized, parallel-controlled trial designed to compare the early re-initiation of semaglutide, starting two weeks after sleeve gastrectomy, to standard care (no pharmacotherapy following surgery). The trial will involve 150 youth with severe obesity who have been on semaglutide 2.4 mg weekly for at least 3 months prior to surgery. Participants will be randomized to either (1) semaglutide 2.4 mg weekly or (2) standard care for 24 months. Primary, secondary, and tertiary outcomes will be assessed at multiple time points: 1-month, day of surgery, and 1-, 3-, 6-, 9-, 12-, 18-, and 24-months postoperatively. We hypothesize that early re-initiation of semaglutide will be safe, well-tolerated, and lead to greater improvements in obesity, cardiometabolic risk, and eating behaviors.

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 must be taking semaglutide 2.4 mg weekly before surgery. You cannot participate if you are taking medications that affect body weight, like prednisone.

Is semaglutide safe for humans?

Semaglutide, used for weight management, has been studied in adults and shows some gastrointestinal side effects like nausea and diarrhea, but it is generally considered safe for use in managing obesity. ^{1 2 3 4 5}

How is the drug semaglutide unique for treating childhood obesity?

Semaglutide is unique because it is a once-weekly injection that mimics a hormone (glucagon-like peptide-1) to help control appetite and weight, and it has shown significant weight loss results in adults, which is now being explored for adolescents. ^{2 3 4 6 7}

What data supports the effectiveness of the drug semaglutide for childhood obesity?

Research shows that semaglutide, a drug used for weight management, has led to significant weight loss in adults, with reductions of about 15% of initial weight over 68 weeks. This suggests it could be effective for managing obesity in children as well. ^{2 3 4 8 9}

Who Is on the Research Team?

Alaina Vidmar, MD

Principal Investigator

Children's Hospital Los Angeles

Are You a Good Fit for This Trial?

This trial is for young individuals with severe obesity who have been taking Semaglutide for at least 3 months and are undergoing sleeve gastrectomy. Participants must be eligible for the surgery and willing to restart medication or follow standard care post-surgery.

Inclusion Criteria

Willing to have clinical data entered into a prospective database

Presence of a consenting caregiver

My body shows moderate to full physical development.

Exclusion Criteria

I agree to follow all the study's requirements.

I have been diagnosed with type 1 diabetes.

I am not on medications that affect my weight or body shape.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Assessment

Preoperative assessments conducted 1 month before surgery and on the day of surgery

1 month

2 visits (in-person)

Treatment

Participants receive semaglutide 2.4 mg weekly or standard care for 24 months postoperatively

24 months

Multiple visits at 1, 3, 6, 9, 12, 18, and 24 months postoperatively

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 if starting Semaglutide, a weight loss medication, soon after weight loss surgery (sleeve gastrectomy) is better than no medication. It's a Phase 3a trial where half of the 150 youth will get the drug weekly and half will receive standard care without drugs.

How Is the Trial Designed?

Group I: Early reinitiation Experimental Treatment 1 Intervention

Early Reinitiation of semaglutide at 2 weeks after bariatric surgery per standard titration starting at 0.25 mg weekly and titrating to 2.4 mg weekly

Group II: Standard Care Active Control 1 Intervention

Standard of care following bariatric surgery. No Reinitiation of obesity optimizing medications.

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials

257

Recruited

5,075,000+

Published Research Related to This Trial

Semaglutide, a glucagon-like peptide-1 receptor agonist, has been shown to produce the largest weight loss of any obesity medication, with an average reduction of about 15% of initial body weight over 68 weeks.

In addition to significant weight loss, semaglutide also improves cardiovascular risk factors and physical functioning, making it a promising option for chronic weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide for the treatment of obesity. Chao, AM., Tronieri, JS., Amaro, A., et al.[2023]

Semaglutide 2.4 mg has been shown to be effective for weight loss in overweight and obese individuals, including those with type 2 diabetes, outperforming all pharmacological comparators in a systematic review of 41 randomized controlled trials.

Participants taking semaglutide were more likely to lose at least 5% of their baseline body weight after 12 weeks of treatment compared to those on other weight management medications, indicating its strong efficacy in promoting significant weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide 2.4 Mg for the Management of Overweight and Obesity: Systematic Literature Review and Meta-Analysis. Smith, I., Hardy, E., Mitchell, S., et al.[2022]

In a meta-analysis of six randomized controlled trials involving 3962 overweight or obese individuals, subcutaneous semaglutide 2.4 mg administered weekly resulted in significant and sustainable weight loss, with an average reduction of 11.8% in body weight compared to placebo.

Semaglutide was well tolerated, with the most common side effects being mild to moderate gastrointestinal issues, indicating a favorable safety profile for non-diabetic overweight or obese individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of semaglutide 2.4 mg for weight loss in overweight or obese adults without diabetes: An updated systematic review and meta-analysis including the 2-year STEP 5 trial. Qin, W., Yang, J., Deng, C., et al.[2023]

In a study involving 2117 participants treated with semaglutide 2.4 mg for 68 weeks, gastrointestinal adverse events (AEs) like nausea and diarrhea were more common than in the placebo group, but these AEs were mostly mild and transient, with only 4.3% of participants discontinuing treatment due to them.

Weight loss with semaglutide was significant and similar in participants with and without GI AEs, indicating that the weight loss effects of semaglutide are largely independent of these gastrointestinal side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastrointestinal tolerability of once-weekly semaglutide 2.4 mg in adults with overweight or obesity, and the relationship between gastrointestinal adverse events and weight loss. Wharton, S., Calanna, S., Davies, M., et al.[2022]

Subcutaneous semaglutide (Wegovy) has been shown to significantly reduce body weight in overweight and obese individuals, with a dose-dependent effect observed in four Phase 3 trials involving 5000 participants.

While semaglutide resulted in greater weight loss compared to placebo, gastrointestinal side effects were the most common safety concerns, highlighting the need for further studies in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical review of subcutaneous semaglutide for obesity. Phillips, A., Clements, JN.[2022]

In a cohort study of 408 adults with obesity, those treated with weekly semaglutide injections (1.7 mg or 2.4 mg) experienced significant weight loss, averaging 5.9% after 3 months and 10.9% after 6 months, which aligns with results from randomized clinical trials.

The majority of patients (87.3%) achieved at least 5% weight loss after 6 months, although those with type 2 diabetes experienced less weight loss compared to those without diabetes, indicating that diabetes status may influence treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Loss Outcomes Associated With Semaglutide Treatment for Patients With Overweight or Obesity. Ghusn, W., De la Rosa, A., Sacoto, D., et al.[2022]

A survey of 127 physicians revealed that many have varying pre-treatment requirements for prescribing semaglutide for weight loss, with 30% requiring a minimum body mass index of 30 kg/m² and 67% expecting documented lifestyle changes.

Despite its effectiveness, over 50% of patients discontinued semaglutide therapy within the first 3 months, primarily due to cost, perceived lack of effectiveness, and concerns about long-term side effects, indicating a need for better patient education and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subcutaneous Semaglutide Use for Weight Management: Practice and Attitudes of Physicians in Israel. Dicker, D., Tamir, O., Lieberman-Segal, G., et al.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Semaglutide for the treatment of obesity. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Once-Weekly Semaglutide in Adolescents with Obesity. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Semaglutide 2.4-mg injection as a novel approach for chronic weight management. [2023]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Semaglutide 2.4 Mg for the Management of Overweight and Obesity: Systematic Literature Review and Meta-Analysis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of semaglutide 2.4 mg for weight loss in overweight or obese adults without diabetes: An updated systematic review and meta-analysis including the 2-year STEP 5 trial. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Gastrointestinal tolerability of once-weekly semaglutide 2.4 mg in adults with overweight or obesity, and the relationship between gastrointestinal adverse events and weight loss. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Clinical review of subcutaneous semaglutide for obesity. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Weight Loss Outcomes Associated With Semaglutide Treatment for Patients With Overweight or Obesity. [2022]

9. Israel pubmed.ncbi.nlm.nih.gov

Subcutaneous Semaglutide Use for Weight Management: Practice and Attitudes of Physicians in Israel. [2023]