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RECRUITING

NCT05574439

PHASE4

Young Adults With Early-onset Obesity Treated With Semaglutide

Sponsor: Signe Torekov

View on ClinicalTrials.gov

Summary

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.

Official title: Young Adults With Early-onset Obesity Treated With Semaglutide -The RESETTLE Study

Key Details

Gender

All

Age Range

18 Years - 28 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2022-06-01

Completion Date

2026-04-30

Last Updated

2025-12-18

Healthy Volunteers

Yes

Conditions

Obesity, Adolescent

Interventions

BEHAVIORAL

TCOC treatment

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.

DRUG

Semaglutide 3 mg/ml

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.

DRUG

Placebo (Semaglutide 3 mg/ml)

Inclusion Criteria: * Age 18-28 years * The period from the initial treatment with TCOC protocol until inclusion in the study must be within 15 years. * Group A: BMI≥30. Non-responders: No BMI SDS reduction (≤0.1 BMI SDS) during TCOC protocol for more than one year and still have obesity. * Group B: BMI≥30. Insufficient responders: BMI SDS reduction ≥0.25 BMI SDS during TCOC protocol for more than one year, but still have obesity. * Group C: BMI≤30. Excellent responders: BMI SDS reduction ≥0.5 BMI SDS during TCOC protocol for more than one year and no longer have obesity. * Group D: Young adults who have participated in The Holbaek Study and have had normal weight development during childhood Exclusion Criteria: * Participants diagnosed with known serious chronic illness including type 1 or 2 diabetes (or a randomly measured fasting plasma glucose \>7 mmol/l) * Angina pectoris, coronary heart disease, congestive heart failure (NYHA III-IV) * Severe renal impairment (creatinine clearance (GFR) \<30 mL/min) * Severe hepatic impairment * Inflammatory bowel disease * Diabetic gastroparesis * Cancer * Chronic obstructive lung disease * Severe psychiatric disease, a history of major depressive or other severe psychiatric disorders * Use of medications causing clinically significant weight gain or loss * Previous bariatric surgery * A history of idiopathic acute pancreatitis * A family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma * Pregnancy, expecting pregnancy or breastfeeding. If a study participant is in doubt whether she could be pregnant, a urine pregnancy test is performed. Women with reproductive potential who are not using adequate contraceptive methods (combined oral contraceptive pill, progestin-only contraceptive pill, condoms, intrauterine device, injection, implant, or sterilization). Adequate contraception must be used throughout the study period and at least 2 months after discontinuation of trial medication (semaglutide will be present in the circulation for 5-7 weeks after the last dose). * Allergy to any of the ingredients/excipients of the study medication: Semaglutide, disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid, sodium hydroxide. * Exclusion criteria for MRI: Pacemaker, claustrophobia, metal splinters or any other magnetic devices that cannot be removed prior to the scan (Participants can join the trial without MR scan)

Locations (2)

Holbæk University Hospital

Holbæk, Region Zeeland, Denmark

University of Copenhagen, Department of Biomedical Sciences

Copenhagen, Denmark