How effective is liraglutide in the treatment of "Prader-Willi syndrome" obesity?

Introduction: A recent study published in the journal Clinical Endocrinology and Metabolism found that liraglutide did not show a significant advantage
over placebo in weight loss in obese children and adolescents with Prader-Willi syndrome.

Study lead Professor Maïthé Tauber of the University of Toulouse, France, said: "In this study, we observed a reduction in BMI standard deviation scores from baseline in children and adolescents, but there was no significant difference between liraglutide and placebo at week 16 and no clear difference
between groups at week 52.
”

Against Prader-Willi syndrome obesity, more weapons are needed clinically

Prader-Willi syndrome (PWS), also known as hypotonia-intellectual disability-hypogonadal delay-obesity syndrome, Prader-Willi syndrome, commonly known as chubby Willi syndrome, is a rare genetic disorder
.
Obesity is one of the common characteristics of patients, with age, weight progressively increased, body fat composition changes, obesity and related complications, is the main cause of patient death, for the treatment of such obesity, clinical need for more weapons
.

Prader-Willi syndrome in different populations abroad incidence of 1/30000~1/10000, the neonatal period is mainly characterized by severe muscle hypotonia, feeding difficulties, external genital dysplasia, hyperphagia after infancy, obesity, learning disabilities and temper, diet, growth hormone and other treatments help to improve the prognosis
.

Typical symptoms of Prader-Willi syndrome

1.
Most of the fetal movements are reduced, and some have intrauterine growth restriction
.

2.
0~9 months of weak hunger, sucking weakness, feeding difficulties, can lead to growth retardation or stagnation
.

3.
9~25 months appetite improvement, normal feeding, growth rate recovery
.

4.
2.
1~4.
5 years old weight gain, but appetite and intake of calorie did not increase
significantly.

5.
4.
5~8 years old gradually appeared appetite, calorie intake is higher than that of
peers.

6.
8 years old ~ adult has excessive appetite, no satiety, can have a short temper and steal due to foraging
.

7.
Adult appetite can be enhanced, normal or weakened, concentration on food is weakened, and there may be a feeling of
fullness.

Exploring new ways to treat obesity in Prader-Willi syndrome, liraglutide has attracted attention

This study included children aged ≥ 6 years who developed less than Tanner stage 2 and adolescent patients aged 12~17 years who developed Tanner stage 2 to 5 for randomized placebo-controlled trials with genetically confirmed Prader-Willi syndrome and obesity
.

Following a 2:1 basis, subjects were randomly assigned to 3 mg liraglutide and placebo for a 16-week double-blind intervention
.
Treatment with liraglutide begins at a dose of 0.
6 mg and increases weekly until the target or maximum tolerated dose
is reached.
From weeks 17 to 52, the liraglutide group continued treatment, while the placebo group received no treatment
other than diet and exercise.
The primary efficacy endpoint was change in
BMI standard deviation scores from baseline to 16 weeks and from baseline to 52 weeks.
In addition, changes in the percentage of participants with at least a 5% or 10% reduction in BMI, weight changes
, vital signs, blood glucose parameters, and fasting lipids were analyzed.

The study cohort included a total of 32 adolescents, 20 randomized to liraglutide and 12 to placebo; The latter 17 were assigned to liraglutide and 7 to placebo
.

Compared with placebo, the liraglutide group showed no significant weight loss

From baseline to 16 weeks and from baseline to 52 weeks:

➤ There was no significant difference in BMI standard deviation scores between the two groups;

➤ The proportion of BMI decreased by ≥5% was similar between the two groups;

Few participants in both groups had a ≥10% decrease in BMI;

Weight change from baseline to 16 and 52 weeks was also similar
between the liraglutide and placebo groups.

Similar to previous studies, gastrointestinal-related adverse events were the most common side effect of liraglutide, with most events being mild or moderate in severity, with few serious adverse events reported
during the study period.

Fig.
1 Changes in the weight of adolescents and children during the experiment

The researchers wrote: "In our trial, the safety profile of liraglutide was generally consistent
with what was observed in other populations.
In the future, further research is needed to investigate the therapeutic potential
of GLP-1 agonists in patients with Prader-Willi syndrome.
”

Resources:

[1] Diene G, Angulo M, Hale PM, et al.
Liraglutide for Weight Management in Children and Adolescents with Prader-Willi Syndrome and Obesity.
JOURNAL OF CLINICAL ENDOCRINOLOGY AND METABOLISM.
2022 Oct 1.
DOI: 10.
1210/clinem/dgac549, PMID:36181471

[2] Michael Monostra.
Liraglutide does not induce greater weight loss in youths with Prader-Willi syndrome.
2022-11-1.
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