Young Adults With Early-onset Obesity Treated With Semaglutide (RESETTLE)
Obesity, Adolescent
About this trial
This is an interventional treatment trial for Obesity, Adolescent focused on measuring GLP-1 RA, Semaglutide, Weight loss, Treatment resistant
Eligibility Criteria
Inclusion Criteria:
- Age 18-28 years
- The period from the initial treatment with TCOC protocol until inclusion in the study must be within 10 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).
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
- 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.
Sites / Locations
- Holbæk University Hospital
- University of Copenhagen, Department of Biomedical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Active Comparator
Placebo Comparator
Active Comparator
Placebo Comparator
No Intervention
Non-responders: TCOC+ semaglutide
Non-responders: TCOC+ placebo
Insufficient responders: TCOC+ semaglutide
Insufficient responders: TCOC+ placebo
Excellent Responders
Semaglutide: 2.4 mg/week SC, concentration: 3.0 mg/ml) in combination with TCOC treatment (i.e. diet/weight consultations).
Placebo: 2.4 mg/week SC in combination with TCOC treatment (i.e. diet/weight consultations).
Semaglutide: 2.4 mg/week SC, concentration: 3.0 mg/ml) in combination with TCOC treatment (i.e. diet/weight consultations).
Placebo: 2.4mg/week SC in combination with TCOC treatment (i.e. diet/weight consultations).