Semaglutide ‘gives hope’ to obese adolescents

Semaglutide ‘gives hope’ to obese adolescents

Semaglutide ‘gives hope’ to obese adolescents

Participants of ObesityWeek® 2022, listened with great excitement to the results of the STEP TEENS Phase 3 trial of a once-weekly subcutaneous injection semaglutide 2.4 mg (Wegovy) in adolescents aged 12 to < 18 years s obesity.

When a panelist said that clinical trials of weight-loss drugs in adolescent obesity should no longer use placebo controls — implying that a comparison with a once-weekly injection of semaglutide would be more informative — the audience applauded.

The results were also simultaneously published in New England Journal of Medicine to match the presentation.

The research “gives hope” to obese adolescents, their parents and doctors, said the trial’s principal investigator, Daniel Weghuber, MD. Medscape Medical News.

“Many of them have struggled for so long – both the parents and the children themselves,” said Weghuber, from the Department of Pediatrics at Paracelsus Medical University, Salzburg, Austria.

“The problem is not a lack of will,” he stressed. “It’s a big misunderstanding.”

“This drug [semaglutide] appears to allow people living with obesity to adhere to recommendations that they may have followed for years and years but [still] they can’t achieve their goal,” he said. It “allows people to achieve their goals.”

Asked about the potential negative impact on normal growth, Weghuber noted that the average weight of study participants was 107 kg (236 lb). “I’m really not afraid of a 15-year-old at 107 kg losing 10%, 15%, 20%” of his weight, he said. There was no indication of problems with normal growth or development in the study.

The research showed that “there is a lifestyle plus combination in future anti-obesity drugs that will open a new chapter” for the treatment of adolescent obesity, he summarized.

The study’s senior author, Silva Arslanian, MD, who holds the Richard L. Day Endowed Chair in Pediatrics at the University of Pittsburgh School of Medicine, agreed. “The results are amazing,” Arslanian said in a University of Pittsburgh press release. “For a person who is 5 feet 5 inches tall and weighs 240 pounds, the average reduction in BMI equates to a loss of about 40 pounds.”

Amazing, fantastic the results

Session at ObesityWeek® In 2022, it was chaired by Dr. sc. Aaron S. Kelly, professor of pediatrics and co-director of the Center for Pediatric obesity Medicine at the University of Minnesota in Minneapolis.

Kelly ran SCALE TEENS Clinical trial from liraglutide (Saxenda), also a glucagon-like peptide (GLP-1) agonist such as semaglutide, for adolescents aged 12 to < 18 years with obesity, which assigned 125 participants to a daily injection of liraglutide and 126 to a was receiving a placebo. SCALE TEENS was introduced and released in May 2020, leading to approval liraglutide for obesity in this age group, in December 2020.

Kelly invited two experts who were not involved in the research to provide their comments, starting with Claudia K. Fox, MD, MPH.

“These results are amazing,” said Fox, associate professor of pediatrics and co-director of the Center for Pediatric Obesity Medicine at the University of Minnesota Medical School.

“We are getting closer gastric surgery results” in these adolescent obesity patients, added Fox, who is a diplomate of the American Board of Obesity Medicine. To have 40% of patients reach a normal weight, “that’s huge” and “life-changing,” she said. And improving quality of life is what what families care about the most.“I’m very excited,” she commented.

Then Kelly called Sarah C. Armstrong, MD, director of Duke Children’s Healthy Lifestyles Program, Duke University, Durham, North Carolina.

Armstrong serves on the Executive Committee of the American Academy of Pediatrics Section on Obesity and is a co-author of upcoming clinical practice guidelines that are being published and will also be discussed at ObesityWeek® in 2022

Looking at more than 16,000 abstracts at the meeting shows that “watchful waiting is not effective,” Armstrong said.

200 teenagers with obesity, only 1 overweight

Obesity affects almost one in five children and adolescents worldwide. Chronic disease is associated with shortened life expectancy and a higher risk of developing serious health problems such as type 2 diabetesheart disease, non-alcoholic fatty liver diseases, sleep apnea and certain types of cancer. Teenagers with obesity are also more likely depressionanxiety, low self-esteem and other psychological problems.

STEP-TEEN included 201 adolescents aged 12 to < 18 years with obesity (body mass index [BMI] ≥ 95th percentile) or overweight (BMI ≥ 85th percentile) plus at least one weight-related comorbidity.

Only one enrolled patient fits the latter category; the rest had obesity.

The majority of patients (62%) were women. They had an average age of 15.4 years, an average BMI of 37 kg/m22and the average waist circumference 110 cm (43 inches).

Patients were randomized 2:1 to receive 2.4 mg subcutaneous injection of semaglutide or placebo once weekly for 68 weeks, plus a lifestyle intervention.

Weghuber noted that 89.6% of patients in the semaglutide group completed treatment.

The primary endpoint, mean change in BMI from baseline to week 68, was -16.1% with semaglutide and +0.6% with placebo (estimated difference, -16.7 percentage points; P < 0.001).

The second confirmatory endpoint, at least 5% weight loss at week 68, was achieved by 73% of patients in the semaglutide group versus 18% of patients in the placebo group (P < 0.001).

Reducing body weight and improving waist circumference, A1c, lipids (except HDL cholesterol), and the liver enzyme alanine aminotransferase were higher with semaglutide than with placebo.

The total score of the Impact of Weight on Quality of Life – Children (IWQOL-Kids) questionnaire, as well as scores for body esteem, family relationship, physical comfort and social life were better in the semaglutide group.

However, the frequency of gastrointestinal side effects was higher with semaglutide than with placebo (62% vs. 42%).

Five participants (4%) in the semaglutide group and none in the placebo group developed gallstones (cholelithiasis).

Serious side effects were reported in 11% of patients in the semaglutide group and 9% of patients in the placebo group.

Big change Guidelines for teenage obesity are coming

Commenting on the upcoming new guidelines for adolescents, Armstrong noted that “there will be a strong recommendation” for therapy in the new pediatric obesity guidelines. “It’s a big change,” she said.

In the lively question-and-answer session that followed, the clinician wanted to know what explained the study’s very high completion rate during the COVID-19 pandemic (when STEP-TEEN was conducted). “What can we learn?” he asked.

“The bottom line is the relationship” and “close communication” between study researchers and patients, Weghuber replied.

“The fast track will probably lead to adolescent approval,” remarked another audience member. He wanted to know if the company planned to test semaglutide in younger children.

They are, Weghuber replied, and one with liraglutide is already underway.

CHILDREN OF THE SCALE Clinical trial liraglutide is randomizing 78 participants aged 6 to < 12 years to 56 weeks of treatment and 26 weeks of follow-up, with an estimated primary end date of July 7, 2023.

The last words went to Fox. Current results are “really great,” she said, but “thousands of providers are hesitant” to prescribe drugs for obese adolescents.

The trial was funded by Novo Nordisk. Weghuber reported being a consultant for Novo Nordisk and a member of the Global Pediatric Obesity Expert Committee for that company. Disclosures for other authors are listed with the article. Kelly reported receiving donated drugs from AstraZeneca and travel support from Novo Nordisk, and serving as an unpaid consultant for Novo Nordisk, Orexigen Therapeutics, VIVUS, and WW (formerly Weight Watchers).

N Engl J Med. Published on November 2, 2022. Abstract

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