Liraglutide for Children 6 to <12 Years of Age with Obesity — A Randomized Trial
Primary result · Mean % change from baseline in BMIResult — go to the resultEstimated difference −7.4 percentage points 95% CI −11.6 to −3.2Authors' conclusion
Among children (6 to <12 years of age) with obesity, treatment with liraglutide for 56 weeks plus lifestyle interventions resulted in a greater reduction in BMI than placebo plus lifestyle interventions.
Study context
- Population
- Children 6 to <12 years of age with obesityrandomized 2:1
- Participants
- 82 children
- Comparison
- Once-daily SC liraglutide 3.0 mg vs placebo, plus lifestyle interventions
- Liraglutiden = 56
- Placebon = 26reference
- Primary endpoint
- Percentage change in body-mass index (BMI)
- Follow-up
- Week 56
Methodological detailsphase 3a, placebo-controlled, 2:1 randomisation, 56-week treatment period and 26-week follow-up period
- Phase 3a
- Placebo-controlled
- 2:1 randomisation
- 56-week treatment period and 26-week follow-up period
Primary result
Mean % change from baseline in BMI
Estimated difference
−7.4 percentage points
95% CI −11.6 to −3.2
P < 0.001
Change by group
Liraglutide
−5.8
mean · %
Placebo
1.6
mean · %
Liraglutidevs Placebo
estimated difference −7.4 percentage points (95% CI −11.6 to −3.2); P < 0.001
As reported in the abstract
Secondary outcomes
Mean, %
| Outcome | Liraglutide | Placebo | Estimated difference (percentage points) (95% CI) | P value | |
|---|---|---|---|---|---|
| Mean % change in body weight (confirmatory secondary) | 1.6 | 10.0 | −8.4 (−13.4 to −3.3) | P = 0.001 | |
| −20−10010Difference, percentage points (linear scale) |
| Outcome | Liraglutide | Placebo | aOR (95% CI) | P value | |
|---|---|---|---|---|---|
| BMI reduction ≥5% (confirmatory secondary) | 46% | 9% | 6.3 (1.4–28.8) | P = 0.02 | |
| 0.050.21520Adjusted odds ratio (log scale) |
Safety
Adverse events
Gastrointestinal adverse events · more common with liraglutide
Serious adverse events
Original publication
Liraglutide for Children 6 to <12 Years of Age with Obesity — A Randomized Trial. N Engl J Med. Published 10 September 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →