Young adults with early-onset obesity treated with the appetite hormone GLP-1 (semaglutide)

Phase 1

• Conditions: Obesity; MedDRA version: 20.0Level: LLTClassification code 10029885Term: Obesity, unspecifiedSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2019-002274-31-DK
• Lead Sponsor: Department of Biomedical Sciences, University of Copenhagen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-03
• Last Update Posted: 6 December 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

•Age 18-28 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).

The period from the initial treatment with TCOC protocol until inclusion in the study must be within 10 years.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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
•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 65 hours after discontinuation of trial medication (65 hours corresponds to 5 times the half-life of Saxenda®).
•Allergy to any of the ingredients/excipients of the study medication: liraglutide, disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid, sodium hydroxide.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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®). <br>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®). <br>C)To identify underlying mechanisms of lifestyle-untreatable versus treatable childhood-onset obesity.<br>;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 in non-responders to TCOCT protocol compared to placebo;Timepoint(s) of evaluation of this end point: week 0 and 68

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Body composition 2) Body weight 3) change in BMI from before to after GLP-1 RA treatment in insufficient responders to TCOCT protocol compared to placebo 4) 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