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The Evira Study: Additional Support During Obesity Treatment

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Study sites: 2 to 3v5
  2. Notable Trial status: Not Yet Recruiting to Recruitingv4 Show 7 more changesShow less
    • Primary completion date: Aug 29, 2026 to Apr 1, 2027
    • Start date changed from estimate of Oct 7, 2025 to Feb 13, 2026
    • Study sites: 1 to 2
    • Study completion date: Oct 2026 to May 1, 2027
    • Interventions: Anti-obesity medication with liraglutide or semaglutide (Drug), Digi-physical treatment tool, Evira (Device) to Digi-physical treatment tool, Evira (Device), Obesity medication with liraglutide or semaglutide (Drug)
    • Study description revised
    • Study title revised
  3. Notable Start date: Aug 29, 2025 to Oct 7, 2025v3
  4. Notable Start date: Apr 1, 2025 to Aug 29, 2025
    • Primary completion date: Aug 2026 to Aug 29, 2026
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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. The main question it aims to answer is: \- Can a combination of a digi-physical treatment tool and obesity medication improve treatment outcomes for patients with obesity compared to patients treated with obesity medications alone? 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). Participants will be followed for six months.
Trial Details
NCT Number NCT06836284
Lead Sponsor Karolinska Institutet
Collaborators: Evira AB
Conditions
(from sponsor)
Childhood Obesity, Treatment Adherence
Related terms Pediatric Obesity, Treatment Adherence and Compliance
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov