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Young adults with early-onset obesity treated with semaglutide -The RESETTLE study - a randomized double blind placebo-controlled clinical trial
EU CTIS ID: 2024-518086-99-00
What this study is testing
A) To treat young adults with childhood-onset obesity, who have been resistant to structured lifestyle intervention (TCOC protocol), with the GLP-1 RA semaglutide 2.4mg for 68 weeks. B) To treat young adults with childhood-onset obesity, who have responded with insufficient weight loss to the structured lifestyle intervention (TCOC protocol) and remain obese, with the same GLP-1 RA, semaglutide 2.4mg for 68 weeks. C) To identify underlying mechanisms of lifestyle-untreatable versus treatable childhood-onset obesity.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • 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 (BMI≥30).
- 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 (BMI≥30).
- Only baseline examination: 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 (BMI<30).
- Only baseline examination: Group D: Young adults who have participated in The Holbaek Study and have had normal weight development during childhood.
You likely can't join if
- Participants diagnosed with known serious chronic illness including type 1 or 2 diabetes (or a randomly measured fasting plasma glucose > 7 mmol/l)
- 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).
See the full eligibility 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 (BMI≥30).
- 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 (BMI≥30).
- Only baseline examination: 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 (BMI<30).
- Only baseline examination: 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)
- 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 hydrogen phosphate dihydrate, hydrogen chloride, sodium chloride, sodium hydroxide and water for injection.
- Exclusion criteria for MRI: e.g., pacemaker, claustrophobia, etc.
- 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 serious psychiatric disorders
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.