Young adults with early-onset obesity treated with semaglutide -The RESETTLE study - a randomized double blind placebo-controlled clinical trial

Prior treatment

• Use of medications causing clinically significant weight gain or loss
• Previous bariatric surgery
• 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).

Other illness

• A history of idiopathic acute pancreatitis
• A family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma
• Angina pectoris, coronary heart disease, congestive heart failure (NYHA III-IV)
• Severe hepatic impairment
• Inflammatory bowel disease
• Cancer
• Chronic obstructive lung disease
• Severe psychiatric disease, a history of major depressive or other serious psychiatric disorders

Lab values

• Participants diagnosed with known serious chronic illness including type 1 or 2 diabetes (or a randomly measured fasting plasma glucose > 7 mmol/l)
• 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.
• Severe renal impairment (creatinine clearance (GFR) <30 mL/min)

Other

• Diabetic gastroparesis

• 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.