Clinical Trial Radar

Name: Young Adults With Early-onset Obesity Treated With Semaglutide -The RESETTLE Study
Creator: Signe Torekov
Published: 2022-10-10
License: https://www.clinicaltrials.gov/about-site/terms-conditions#availability

beta

Trial Radar AI Trial Candidate or Patient Patient Caregiver Healthcare Pro Biotech Pro Biotech Investor Researcher Other
	Clinical Trial NCT05574439 (RESETTLE) for Obesity, Adolescent is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.

One study matched filter criteria

Card View

Young Adults With Early-onset Obesity Treated With Semaglutide (RESETTLE) Phase 4 180 Randomized Placebo-Controlled International Pediatric

Recruiting

Clinical Trial NCT05574439 (RESETTLE) is designed to study Treatment for Obesity, Adolescent. It is a Phase 4 interventional study that is recruiting, having started on June 1, 2022, with plans to enroll 180 participants. Led by Signe Torekov, it is expected to complete by April 30, 2026. The latest data from ClinicalTrials.gov was last updated on December 18, 2025.

Brief 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 recep...

Detailed Description

Background:

The prevalence of obesity in adolescents has increased markedly in the past decades, thus entailing increased cumulative incidences of type 2 diabetes, cardiovascular disease, and chronic kidney disease (1). Adolescents with obesity are at a substantially elevated risk of developing morbid obesity and type 2 diabetes in early adulthood (2,3) and a recent large scale meta-analysis revealed that mortality ...

Official Title

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

Conditions

Obesity, Adolescent

Publications

GBD 2015 Obesity Collaborators; Afshin A, Forouzanfar MH, Reitsma MB, Sur P, Estep K, Lee A, Marczak L, Mokdad AH, Moradi-Lakeh M, Naghavi M, Salama JS, Vos T, Abate KH, Abbafati C, Ahmed MB, Al-Aly Z, Alkerwi A, Al-Raddadi R, Amare AT, Amberbir A, Amegah AK, Amini E, Amrock SM, Anjana RM, Arn...

Other Study IDs

RESETTLE
U1111-1215-8606
2019-002274-31 (EudraCT Number)

NCT ID Number

NCT05574439

Start Date (Actual)

2022-06-01

Last Update Posted

2025-12-18

Completion Date (Estimated)

2026-04-30

Enrollment (Estimated)

180

Study Type

Interventional

PHASE

Phase 4

Status

Recruiting

Keywords

GLP-1 RA
Semaglutide
Weight loss
Treatment resistant

Primary Purpose

Treatment

Design Allocation

Randomized

Interventional Model

Parallel

Masking

Quadruple

Arms / Interventions

Participant Group/Arm	Intervention/Treatment
Active ComparatorNon-responders: TCOC+ semaglutide Semaglutide: 2.4 mg/week SC, concentration: 3.0 mg/ml) in combination with TCOC treatment (i.e. diet/weight consultations).	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. 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.
Placebo ComparatorNon-responders: TCOC+ placebo Placebo: 2.4 mg/week SC in combination with TCOC treatment (i.e. diet/weight consultations).	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. Placebo (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.
Active ComparatorInsufficient responders: TCOC+ semaglutide Semaglutide: 2.4 mg/week SC, concentration: 3.0 mg/ml) in combination with TCOC treatment (i.e. diet/weight consultations).	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. 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.
Placebo ComparatorInsufficient responders: TCOC+ placebo Placebo: 2.4mg/week SC in combination with TCOC treatment (i.e. diet/weight consultations).	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. Placebo (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.
No InterventionExcellent Responders and Population-based reference group No intervention.	N/A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in BMI (weight in kg/height in m^2)	Weight will be measured to the nearest 0.1 kg. The same set of scales should ideally be used throughout the trial. Weight should be measured in a fasting state without shoes and wearing light indoor clothes. Height will be measured to the nearest 0.1 cm.	Change from baseline to end-of-treatment (68 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body composition (fat mass)	Dual-energy X-ray absorptiometry scans will be performed in fasting state to measure body fat mass (kg).	Change from baseline to end-of-treatment (68 weeks)
Change in body composition (fat percentage)	Dual-energy X-ray absorptiometry scans will be performed in fasting state to measure body fat percentage (%).	Change from baseline to end-of-treatment (68 weeks)
Change in body composition (fat free mass)	Dual-energy X-ray absorptiometry scans will be performed in fasting state to measure fat-free mass (kg).	Change from baseline to end-of-treatment (68 weeks)
Change in visceral fat and liver fat	MRI will be performed in fasting state to measure fat content	Change from baseline to end-of-treatment (68 weeks)
Change in metabolic syndrome	z-score	Change from baseline to end-of-treatment (68 weeks)
Change in waist-to-height ratio	waist-to-height ratio	Change from baseline to end-of-treatment (68 weeks)
Compare BMI (weight in kg/height in m^2), body composition, body weight, and metabolic health between population-based reference group, excellent responders, non-responders and insufficient responders.	Dual-energy X-ray absorptiometry scans will be performed in fasting state to measure fat mass and lean mass (kg)	Baseline comparison and change from baseline to end-of-treatment (68 weeks)
Change in body weight	Body weight change and proportion with at least 5%, 10%, 15%, and 20%	Change from baseline to end-of-treatment (68 weeks)
Change in metabolic syndrome	Prevalence (%)	Change from baseline to end-of-treatment (68 weeks)

Participation Assistant

Eligibility Criteria

Eligible Ages

Adult

Minimum Age

18 Years

Eligible Sexes

All

Accepts Healthy Volunteers

Yes

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

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)

Signe Torekov

🎓University of Le...

Study Responsible Party

Signe Torekov, Sponsor-Investigator, Professor, University of Copenhagen

Study Central Contact

Contact: Signe S Torekov, Prof, PhD, +4535327509, [email protected]

Contact: Sarah Byberg, MD, PhD, +4550247452, [email protected]

2 Study Locations in 1 Countries

Denmark

Region Zeeland

Holbæk University Hospital, Holbæk, Region Zeeland, 4300, Denmark

Jens-Christian Holm, Ass. Prof, PhD, Contact, +4526207533, [email protected]

Not yet recruiting

University of Copenhagen, Department of Biomedical Sciences, Copenhagen, 2200, Denmark

Signe S Torekov, Contact, +4535327509 / +4522983827, [email protected]

Sarah Byberg, Contact, +4550247452, [email protected]

Recruiting

Young Adults With Early-onset Obesity Treated With Semaglutide (RESETTLE) Phase 4 180 Randomized Placebo-Controlled International Pediatric

Inclusion Criteria

Exclusion Criteria