Young Adults With Early-onset Obesity Treated With Semaglutide

Sponsor
Signe Torekov
Study ID
NCT05574439
Phase
PHASE4
Status
Completed

Conditions

  • Obesity, Adolescent

Eligibility Criteria

Sex
ALL
Age
18 Years - 28 Years
Healthy Volunteers
Accepted

Interventions

  • TCOC treatment — BEHAVIORAL
    The TCOC protocol is a chronic care, family-based and multidisciplinary childhood obesity treatment program involving behavior-changing techniques, based on current guidelines for best-practice and authoritative recommendations involving a multidisciplinary tertiary team of health care professionals.
  • Semaglutide 3 mg/ml — DRUG
    Participants will be instructed to initiate at 0.24 mg SC once weekly for 4 weeks, and in 4 week intervals, increase the dose until a dose of 2.4 mg is reached. In case of prolonged side effects the dose may be adjusted to lower than 2.4mg/week.
  • Placebo (Semaglutide 3 mg/ml) — DRUG
    Participants will be instructed to initiate at 0.24 mg SC once weekly for 4 weeks, and in 4 week intervals, increase the dose until a dose of 2.4 mg is reached. In case of prolonged side effects the dose may be adjusted to lower than 2.4mg/week.

Study Details

Introduction: The increasing prevalence of obesity is particularly pronounced among adolescents. Currently available treatment options consist of structured lifestyle interventions. However, 25 % of adolescents do not respond to lifestyle treatment, why new effective treatment strategies are needed. Therefore, the aim of this study is to investigate the effect of lifestyle interventions combined with the GLP-1 receptor agonist semaglutide to young adults with otherwise treatment resistant obesity. Methods and analysis: This is an investigator-initiated, randomized, placebo-controlled trial. 180-270 young adults (age 18-28) will be recruited from The Childrens Obesity Clinic (TCOC), Department of Pediatrics, Holbæk Hospital. Based on their previous response to the TCOC protocol the participants will be divided in four groups: Group A: Non-responders: 55-85 young adults with obesity (BMI≥30 kg/m2) who have not reduced adiposity, defined as BMI SDS reduction \<0.1, during the structured lifestyle counselling as children. Group B: Insufficient responders: 55-85 young adults who have reduced adiposity, defined as BMI SDS reduction \>0.25, during the structured lifestyle counselling as children but still have obesity as young adults (BMI≥30 kg/m2) Group C: Excellent responders: 35-50 young adults, who have reduced adiposity, defined as BMI SDS reduction \>0.5, during the structured lifestyle counselling as children and no longer have obesity as young adults (BMI\<30 kg/m2) Group D: Population-based reference group (normal weight development): 35-50 young adults, who have participated in The Holbaek Study as children. Group A and B are randomized 2:1 to either semaglutide or placebo for 68 weeks. Group C and D will attend baseline examinations only and not undergo intervention. The primary endpoint is change in BMI from randomization to end-of-treatment. Ethics and dissemination: The trial has been approved by the Danish Medicines Agency (EudraCT 2019-002274-31) and by the ethical committee of the Capital Region of Denmark (H-20039422). The trial will be conducted in agreement with the Declaration of Helsinki and monitored to follow the guidelines for good clinical practice. Results will be submitted for publication in international peer-reviewed scientific journals.

Key Dates

Start date
Jun 1, 2022
Status verified
Apr 2026
Primary completion
Apr 1, 2026
Completion
Apr 1, 2026

Study Design

Enrollment
246 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Non-responders: TCOC+ semaglutide
    Semaglutide: 2.4 mg/week SC, concentration: 3.0 mg/ml) in combination with TCOC treatment (i.e. diet/weight consultations).
  • Placebo Comparator: Non-responders: TCOC+ placebo
    Placebo: 2.4 mg/week SC in combination with TCOC treatment (i.e. diet/weight consultations).
  • Active Comparator: Insufficient responders: TCOC+ semaglutide
    Semaglutide: 2.4 mg/week SC, concentration: 3.0 mg/ml) in combination with TCOC treatment (i.e. diet/weight consultations).
  • Placebo Comparator: Insufficient responders: TCOC+ placebo
    Placebo: 2.4mg/week SC in combination with TCOC treatment (i.e. diet/weight consultations).
  • No Intervention: Excellent Responders and Population-based reference group
    No intervention.

Primary Outcome Measure

Change in BMI (weight in kg/height in m^2) [ Time Frame: Change from baseline to end-of-treatment (68 weeks) ]

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