Far more teens with obesity treated with 2.4 mg semaglutide (Wegovy) returned to normal weight or dropped below the obesity threshold compared with placebo-treated patient, a secondary analysis of the phase IIIa STEP TEENS trial found.
During the 68-week trial, 44.9% of teens with obesity returned to either normal weight or went down to the overweight category while on treatment compared with only 12.1% of those on placebo (OR 22.7, 95% CI 7.6-67.9), reported Aaron S. Kelly, PhD, of the University of Minnesota Medical School in Minneapolis, and colleagues.
And by the end of the trial, about 25% versus 2%, respectively, dropped to normal weight status, according to findings presented at the annual European Congress on Obesity in Dublin and simultaneously published in Obesity.
"These results underscore the high degree of clinical effectiveness of semaglutide in adolescents with obesity," said Kelly in a statement. "In a practical sense, we see that semaglutide reduced weight to a level below what is defined as clinical obesity in nearly 50% of the teens in our trial, which is historically unprecedented with treatments other than bariatric surgery."
"If an adolescent has medical indications for an anti-obesity medication, I believe that healthcare providers should offer that as part of the comprehensive treatment approach," Kelly added during a press conference. "Talking about treatment approach for obesity -- it's not just one thing. It's lifestyle therapy, which was included in this trial, it's the use of anti-obesity medications if indicated, and even for some, metabolic and bariatric surgery."
At the start of the trial, teens on the glucagon-like peptide-1 (GLP-1) receptor agonist were generally split between the three obesity classes: class I (n=69; 31.6% of participants), class II (n=69; 33.1%), class III (n=62; 35.3%).
By the end of the trial:
- 25.4% of semaglutide-treated participants were normal weight
- 19.5% were overweight
- 22% had class I obesity
- 19.5% had class II obesity
- 13.6% had class III obesity
On the other hand, the proportion of those falling into class III increased for those on placebo (19% to 22.4%), but dropped for obesity classes I (39.7% to 32.8%) and II (41.4% to 32.8%). Only 10.3% of those on placebo achieved overweight and 1.7% achieved normal weight.
Obesity classes were defined by the CDC body mass index (BMI) growth charts:
- Class I: BMI in the ≥95th to <120% of the 95th percentile
- Class II: BMI ≥120% to <140% of the 95th percentile
- Class III: BMI ≥140% of the 95th percentile
There was also 23.5-higher odds of teens improving at least one BMI category with semaglutide versus placebo (OR 23.5, 95% CI 9.9-55.5, P<0.0001), seen in 73.7% of treated patients versus 19% of placebo patients. A total of 44.9% of teens on semaglutide improved two or more BMI categories versus only 3.4% of those on placebo.
These findings build on the pivotal findings of the STEP Teens trial, presented at the 2022 ObesityWeek annual meeting and published in the New England Journal of Medicine. Here, the mean change in BMI from baseline was a 16.1% reduction with semaglutide compared with a 0.6% increase with placebo (P<0.001) at week 68. On average, participants on semaglutide lost 15.3 kg (33.7 lb), while those on placebo gained 2.4 kg (5.3 lb).
These data laid the groundwork for FDA approving the injectable for people with obesity ages 12 and up in December 2022.
"The degree of body weight reduction is unprecedented," lead study author Daniel Weghuber, MD, of Paracelsus Medical University in Salzburg, Austria, told MedPage Today at the ObesityWeek meeting. "After years of frustration, all of a sudden patients were actually losing weight. They'd never seen that before."
The popular agent was initially approved for adults in June 2021.
Although the study wasn't designed to test sex differences, the BMI treatment differences were numerically -- but not statistically -- greater in females than males. The same was true for patients ages 12 to under 15 compared with those 15 to under 18.
Only patients with obesity were included in this post-hoc analysis. The average age was 15.5, more than 60% of participants were female, and most were at Tanner stage 5. More than 80% had normoglycemia.
Semaglutide was added to lifestyle intervention, which consisted of healthy nutrition counseling and a goal of 60 minutes of moderate- to high-intensity physical activity per day.
"A question I get a lot is, 'Is this going to solve the obesity problem? Should we just give it to everybody'?" said Kelly. "No and no. It's not going to solve the obesity problem, but it's an important piece to the puzzle in helping to solve it, especially for those who already have obesity."
The study was supported by Novo Nordisk A/S.
Kelly and co-authors reported several ties with industry, including with Novo Nordisk.
Source Reference: Kelly AS, et al "Reducing BMI below the obesity threshold in adolescents treated with once-weekly subcutaneous semaglutide 2.4 mg" Obesity 2023; DOI: 10.1002/oby.23808.