The Evira Study: Additional Support During Obesity Treatment

What Was Tested

In this not phased trial, researchers set out to test Semaglutide and Liraglutide.

The goal of this clinical trial is to evaluate the effect of adding a digi-physical treatment tool as a complement to the local treatment with obesity medication in adolescents with obesity.

This is a randomized controlled two-arm multicenter study where participants will be randomized to the intervention group (digi-physical treatment+medication) or control group (medication only).

It had two arms (groups): one (active comparator) and Control group (other).

Patients randomized to this group will receive liraglutide or semaglutide treatment according to the clinic's standard procedures.

The registry classes the interventions as device and drug.

More on the Plan

Treatments with the medications liraglutide and semaglutide have been tested, showing effects of -0.23 and -1.10 BMI SDS units, respectively, after approximately one year in individuals aged 12-17 years.

However, long-term results indicate that many patients, after discontinuing medication, quickly return to the same degree of obesity they had at the start of the study.

This underscores the need to evaluate whether the effect can be optimized by combining medication with digital treatment tools.

The tool includes daily measurements conducted in the home of the patient on a measuring device that do not display any numbers.

Who Took Part

Enrollment: 40 planned participants were the target.

It was open to people of any sex aged from 12 years up to 17 years.

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

Examples of who could join: Patients offered liraglutide or semaglutide in accordance with the clinic's routines. Aged 12-17 years at the time of inclusion. The family agrees to participate in a clinical study.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: endocrine disorders other than well-controlled hypothyroidism; severe neuropsychiatric disorders that may affect adherence to the study; eating disorder requiring treatment within the last six months before inclusion or observed during screening prior to inclusion.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

The Semaglutide group and the comparison group ran side by side rather than switching.

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

It started in 2026-02-13 with completion listed for 2027-04-01.

It ran at 3 sites in Sweden (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in BMI SDS (time frame: From start of treatment to six months follow-up).

It also tracked 6 secondary outcomes, for example Treatment Adherence, Side effects, Professionals perception of the digital tool, Patients perception of the treatment and digital tool and Patients Quality of life.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Semaglutide and Liraglutide in 40 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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