Liraglutide (Saxenda(R)) in Adolescents With Obesity After Sleeve Gastrectomy

What Was Tested

The trial (phase 2) is built around Liraglutide.

However, many adolescents who have this surgery still have obesity 1 year later or regain weight.

Researchers want to see if a drug can help.

It had 1 arm (groups): Liraglutide (experimental).

Treated with Liraglutide.

The registry classes the interventions as drug.

More on the Plan

Hypothesis: The Primary Endpoint is estimation of required sample size for a later randomized controlled trial through calculation of effect size for change in body mass index (BMI) from baseline to 16 weeks of liraglutide.

The hypothesis is: The data will be sufficient to calculate the effect size for change in BMI from baseline to 16 weeks for a 2-group experiment (placebo versus liraglutide).

Endpoints: Primary Endpoint: Estimation of required sample size for a later RCT through calculation of effect size for change in body mass index (BMI) from baseline to 16 weeks of liraglutide.

Additional (exploratory) Endpoints: Change from baseline to 16 weeks of liraglutide in: 1.

Who Took Part

The registry lists 34 actual participants took part.

It was open to people of any sex aged from 12 years up to 20 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female, 12-20.999 years at screening visit. 12 months or more status-post vertical sleeve gastrectomy with a maximum of 10 years after surgery. BMI 30 kg/m2 or greater than or equal to 95th percentile for age and sex. Ability to take subcutaneous medication and be willing to adhere to the daily subcutaneous liraglutide regimen. Ability to provide consent/assent before any trial-related activities as required per protocol.

The full record lists 8 inclusion and 16 exclusion criteria; among the exclusions: weight of more than 450 lbs. (because dual-energy x-ray absorptiometry (dxa) scanning cannot be done in those exceeding this weight); current use of insulin or sulfonylurea or other medication affecting insulin secretion or glp1 clearance such as a dppiv inhibitor; current pregnancy, desire to become pregnant within study period, current lactation or, if sexually active, not willing to use adequate contraceptive measures.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Liraglutide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2021-06-21 with completion listed for 2024-03-15.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Cohen's d (the Standardized Mean Difference) (time frame: 16 weeks).

It also tracked 4 secondary outcomes, for example Change in Fat Mass, Change in BMI, Change in Body Mass Index Z-score and Change in Body Weight.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Liraglutide in 34 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Liraglutide compound page, all human trials.