Treatment for young adults with early-onset obesity using Semaglutide
Young Adults with Early-onset Obesity Treated with Semaglutide -The RESETTLE Study
This study is testing if a combination of lifestyle changes and the medication semaglutide can help young adults aged 18-28 with obesity who haven't had success with other weight loss methods.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 28 Years |
| Sex | All |
| Sponsor | University of Copenhagen Academic / other |
| Locations | 2 sites (Holbæk, Region Zeeland and 1 other locations) |
| Trial ID | NCT05574439 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of combining lifestyle interventions with the GLP-1 receptor agonist semaglutide in young adults aged 18-28 who have treatment-resistant obesity. Participants will be recruited from The Children's Obesity Clinic and divided into four groups based on their previous responses to lifestyle treatments. The study is randomized and placebo-controlled, aiming to assess weight loss outcomes and improvements in health markers. The trial seeks to provide a new treatment avenue for those who have not succeeded with traditional weight loss methods.
Who should consider this trial
Good fit: Ideal candidates are young adults aged 18-28 with a BMI of 30 or higher who have not responded to previous lifestyle interventions.
Not a fit: Patients with serious chronic illnesses such as type 1 or 2 diabetes or severe renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve weight loss outcomes and overall health for young adults struggling with obesity.
How similar studies have performed: Other studies have shown promise in using GLP-1 receptor agonists for weight management, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Holbæk, Region Zeeland and 1 other locations
- Holbæk University Hospital — Holbæk, Region Zeeland, Denmark (Not_yet_recruiting)
- University of Copenhagen, Department of Biomedical Sciences — Copenhagen, Denmark (Recruiting)
Study contacts
- Study coordinator: Signe S Torekov, Prof, PhD
- Email: torekov@sund.ku.dk
- Phone: +4535327509
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.