Trial · Interventional

CompletedPhase 4Registry data

Young Adults With Early-onset Obesity Treated With Semaglutide

Short name RESETTLE

NCTNCT05574439Other idU1111-1215-8606Other id2019-002274-31Other id2019

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 246 participants (actual)
Sponsor: Signe Torekov · Other
Design: Randomized · Quadruple masking
Countries: 1 country
Denmark
Start: 30 May 2022
Primary completion: 1 Apr 2026
Completion: 1 Apr 2026
First posted: 10 Oct 2022
Last update posted: 8 Jul 2026
Conditions: Obesity, Adolescent

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202220232024202520262027

Ph 4
RESETTLE
NCT05574439
30 May 2022 to 1 Apr 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

TCOC treatmentBehavioral
Semaglutide 3 mg/mlDrug
Placebo (Semaglutide 3 mg/ml)Drug

Arms5

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 outcomes1

Outcomes the sponsor listed as primary.

Change in BMI (weight in kg/height in m^2)
Time frame · Change from baseline to end-of-treatment (68 weeks)
Registry description
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.

Secondary outcomes(9)

Change in body composition (fat mass)
Time frame · Change from baseline to end-of-treatment (68 weeks)
Registry description
Dual-energy X-ray absorptiometry scans will be performed in fasting state to measure body fat mass (kg).
Change in body composition (fat percentage)
Time frame · Change from baseline to end-of-treatment (68 weeks)
Registry description
Dual-energy X-ray absorptiometry scans will be performed in fasting state to measure body fat percentage (%).
Change in body composition (fat free mass)
Time frame · Change from baseline to end-of-treatment (68 weeks)
Registry description
Dual-energy X-ray absorptiometry scans will be performed in fasting state to measure fat-free mass (kg).
Change in visceral fat and liver fat
Time frame · Change from baseline to end-of-treatment (68 weeks)
Registry description
MRI will be performed in fasting state to measure fat content
Change in metabolic syndrome
Time frame · Change from baseline to end-of-treatment (68 weeks)
Registry description
z-score
Change in waist-to-height ratio
Time frame · Change from baseline to end-of-treatment (68 weeks)
Registry description
waist-to-height ratio
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.
Time frame · Baseline comparison and change from baseline to end-of-treatment (68 weeks)
Registry description
Dual-energy X-ray absorptiometry scans will be performed in fasting state to measure fat mass and lean mass (kg)
Change in body weight
Time frame · Change from baseline to end-of-treatment (68 weeks)
Registry description
Body weight change and proportion with at least 5%, 10%, 15%, and 20%
Change in metabolic syndrome
Time frame · Change from baseline to end-of-treatment (68 weeks)
Registry description
Prevalence (%)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies5

Studies that cite this trial.

Studies with results

5 studies on this page

Indexing hint: Randomized controlled trial · 2022

14 results

Effect of Weekly Subcutaneous Semaglutide vs Daily Liraglutide on Body Weight in Adults With Overweight or Obesity Without Diabetes: The STEP 8 Randomized Clinical Trial.

Rubino et al. 2022JAMAcited by 749

PMID 35015037PMC8753508DOI 10.1001/jama.2021.23619PUB-35015037

Rights unknown14 results

Source link See results (14)

Indexing hint: Randomized controlled trial · 2022

4 results

Exploratory analysis of eating- and physical activity-related outcomes from a randomized controlled trial for weight loss maintenance with exercise and liraglutide single or combination treatment.

Jensen et al. 2022Nature communicationscited by 34

PMID 35970829PMC9378667DOI 10.1038/s41467-022-32307-yPUB-35970829

CC BY4 results

Download PDF See results (4)

Indexing hint: Randomized controlled trial · 2021

14 results

Healthy Weight Loss Maintenance with Exercise, Liraglutide, or Both Combined.

Lundgren et al. 2021The New England journal of medicinecited by 417

PMID 33951361DOI 10.1056/nejmoa2028198PUB-33951361

Full text at the publisher14 results

Publisher page See results (14)

Indexing hint: Clinical trial · 2018

7 results

Patients with Obesity Caused by Melanocortin-4 Receptor Mutations Can Be Treated with a Glucagon-like Peptide-1 Receptor Agonist.

Iepsen et al. 2018Cell metabolismcited by 109

PMID 29861388DOI 10.1016/j.cmet.2018.05.008PUB-29861388

Full text at the publisher7 results

Publisher page See results (7)

Indexing hint: Randomized controlled trial · 2015

7 results

Treatment with a GLP-1 receptor agonist diminishes the decrease in free plasma leptin during maintenance of weight loss.

Iepsen et al. 2015International journal of obesity (2005)cited by 87

PMID 25287751PMC4424381DOI 10.1038/ijo.2014.177PUB-25287751

Free to read · publisher termsCC BY-NC-ND7 results

Read at source See results (7)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 28 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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)

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