Study of Liraglutide as a Weight Loss Treatment for Adolescents

Treating obesity in childhood and teen years has always presented significant challenges for health professionals as options are significantly more limited than for adults. Even obesity drugs are less widely available, and other interventions are generally considered inappropriate.

So far, the FDA has only approved two drugs for weight loss in young adults and teens: orlistat and phentermine.

A study led by Dr. Kelly at the Center for Pediatric Obesity Medicine (University of Minnesota) examined whether liraglutide might be a suitable candidate for weight loss treatments in adolescents ( 1 ).

Study Results

Overall, the study showed that the combination of lifestyle therapy and the daily administration of 3.0mg liraglutide resulted in increased weight loss in young adults. Compared with the placebo group, the treatment group saw both a higher total weight loss, greater average weight loss per participant, and a more significant BMI reduction.

More specifically, over the treatment period of 56 weeks, 26.1% of the treatment group witnessed a 10% reduction in total BMI, compared to 8.1% of the placebo group. 43.37% of the treatment group saw at least a 5% reduction in BMI, compared to 18.7% of the placebo.

That means that the combination of both lifestyle therapy and liraglutide was significantly more successful in reducing body weight and BMI than lifestyle therapy combined with a placebo.

However, both groups observed a decrease in treatment effectiveness, starting around week 42 of the study. At the same time, there were signs that compliance with the medication might have declined.

Also, in the follow-up period, both the treatment group and the placebo saw a noticeable reversal of the weight-loss trends achieved during the treatment period. That’s an indication that while liraglutide might be a useful tool for weight loss, the results don’t necessarily continue after stopping the weight loss therapy.

The study highlights the need for ongoing lifestyle therapy and lifestyle change, along with the possible need for weight-supportive therapies in addition to weight-loss treatments and medication.

What Is Liraglutide Used For?

Liraglutide is used as a diabetes medication that entails weight loss, rather than managing the symptoms of diabetes.

Currently, liraglutide is approved for use in obese adults, or adults with a BMI in the overweight range and additionally have a comorbid condition that increases their need to reach a healthy weight.

Liraglutide for weight loss has been FDA approved since 2014. It is marketed under the brand name Saxenda.

Liraglutide Side Effects

Like most weight-loss drugs, liraglutide has an extensive list of side effects. However, the most common side effects are mild, including constipation, dizziness, headaches, stomach aches, diarrhea, nausea, and vomiting ( 2 ).

The discussed study had an extremely low incidence of adverse effects. However, the liraglutide treatment group did have noticeably higher gastrointestinal side effects like nausea, stomach aches, and vomiting. Those side effects were more common while participants were increasing their dosage but tapered off once participants were at a maintenance dose.

A few participants in the study did leave because of adverse gastrointestinal effects. The study authors took that as a signal that while liraglutide is a promising weight loss treatment, it’s probably not for everyone.

Summary

The presented study shows that liraglutide is a viable option for the treatment of obesity in adolescents. In combination with lifestyle changes, the medication led to a significant reduction in BMI compared to a placebo plus lifestyle therapy.

This is excellent news since few treatment options are currently available for young adults. However, additional clinical studies still are needed to confirm the results of the effectiveness of liraglutide for treating obesity in adolescents.

Study Size and Methodology

251 participants were randomized, with 125 in the liraglutide treatment group and 126 in the placebo group. Treatment at week 56 was completed by 101 in the liraglutide group and 100 in the placebo group.

Lifestyle therapy, including counseling about healthy nutrition and physical activity specifically for weight loss, was given during the 12 weeks before the study. Interested individuals who met the study qualifications (251/299) were then randomized into the treatment and placebo groups.

Doses started at 0.6mg 1x daily for the first week and increased weekly to 3mg daily, which is the maximum tolerated dose of liraglutide. Treatment then continued until week 56, when it was discontinued. Liraglutide was delivered subcutaneously, meaning that it was injected under the skin.

References
  1. Kelly AS, Auerbach P, Barrientos-Perez M, Gies I, Hale PM, Marcus C, Mastrandrea LD, Prabhu N, Arslanian S; NN8022-4180 Trial Investigators. A Randomized, Controlled Trial of Liraglutide for Adolescents with Obesity. N Engl J Med. 2020 May 28;382(22):2117-2128. doi: 10.1056/NEJMoa1916038. Epub 2020 Mar 31. PMID: 32233338.
  2. Web MD Liraglutide Pen Injector Side Effects by Likelihood and Severity.