RecruitingPhase NA

The Evira Study: Additional Support During Obesity Treatment

Evaluation of a Digital Treatment Tool in Combination With Obesity Medications

Lead sponsor

Karolinska Institutet

Assets

Liraglutide / Semaglutide

Listed sites

Recruiting sites

Estimated enrollment

Study population

Obesity / overweight

Eligibility highlights

•Age 12-17

Primary endpoint

•BMI SDS, change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06836284

Org study ID2024-07214-01

Timeline

Milestones

Study first posted2025-02-20actual

Study start2026-02-13actual

Last update posted2026-05-05actual

Primary completion2027-04-01estimated

Study completion2027-05-01estimated

Assets

Investigational agents

Liraglutide Semaglutide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age12 Years

Maximum age17 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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.

Exclusion criteria

•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.

•Somatic conditions that may complicate the evaluation of treatment outcomes, such as patients on irregular oral corticosteroid treatment.

•Hypothalamic or monogenic obesity, and genetic syndromes such as Down syndrome.

•Patients deemed unsuitable for participation by the responsible physician.

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Patient-reported / QoL

Weight & body composition

Safety / tolerability / PK

Other (unclassified)

Weight & body composition

2 endpoints

Primary/protocol endpoint

Change in BMI SDS

Time frame:From start of treatment to six months follow-up

BMI SDS, change

change from baseline, improvement

Secondary/protocol endpoint

Proportion achieving less favorable reduction in BMI SDS

Time frame:From start of treatment to six months follow-up

BMI SDS, change

threshold achievement, improvement

Patient-reported / QoL

3 endpoints

Secondary/protocol endpoint

Professionals perception of the digital tool

Time frame:From start of treatment to six months follow-up

descriptive

Secondary/protocol endpoint

Patients perception of the treatment and digital tool

Time frame:From start of treatment to six months follow-up

descriptive

Secondary/protocol endpoint

Patients Quality of life

Time frame:From start of treatment to six months follow-up

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Side effects

Time frame:From start of treatment to six months follow-up

Treatment-emergent AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Discontinuation due to AE

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Treatment Adherence

Time frame:From start of treatment to six months follow-up

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.