Obesity MedDRA version: 20.0 Level: LLT Classification code 10029885 Term: Obesity, unspecified System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: Semaglutide 3.0 mg/mL
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Semaglutide
CAS Number: 910463-68-2
Concentration unit: mg/ml milligram(s)/millilitre
Concentration
Sponsors
Department of Biomedical Sciences, University of Copenhagen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age 18-28 years • Group A: BMI=30. Non-responders: No BMI SDS reduction (0.25 BMI SDS during TCOC protocol for more than one year, but still have obesity. • Group C: BMI0.5 BMI SDS during TCOC protocol for more than one year and no longer have obesity (BMI=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • Patients 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 • The use of medications that cause 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 (Wegovy®). B)To treat young adults with childhood-onset obesity, who have responded to the structured lifestyle intervention (TCOC protocol) and still have obesity, with the same GLP-1 RA, semaglutide (Wegovy®). C)To identify underlying mechanisms of lifestyle-untreatable versus treatable childhood-onset obesity. D)Assess the efficacy of an exercise-based strategy to discontinue obesity medication while sustaining a healthy body composition in youth with childhood-onset obesity ;Secondary Objective: Determine the effect of a GLP-1 receptor agonist on body composition and metabolic health in young adults with obesity;Primary end point(s): Change in BMI from before to after GLP-1 RA treatment compared to placebo;Timepoint(s) of evaluation of this end point: week 0 and 68 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Body composition 2) Body weight 3) Metabolic health (glucose tolerance and lipid status, waist circumference, blood pressure, Composite Metabolic syndrome Z-score) 4) liver fat 5) weight loss induced bone loss 6) appetite regulation 7) systemic markers of immuno-metabolism 8) immuno-metabolic profile of adipose tissue 9) circulating inflammatory cells (PBMCs) 10) food preferences and appetite sensation 11) genetic risk scores 12) microbiota 13) metabolomics;Timepoint(s) of evaluation of this end point: week 0 and 68 | — |
Countries
Denmark
Contacts
Public ContactSigne Torekov
Department of Biomedical Sciences, Faculty of Health Sciences, University of Copenhagen
Outcome results
None listed