Young Adults With Early-onset Obesity Treated With Semaglutide

• Status: Recruiting
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Introduction: Obesity prevalence is particularly pronounced among adolescents. Currently available treatment options consists of structured lifestyle interventions. However, 25 % of adolescents do not respond to lifestyle treatment, why new effective treatment strategies are needed. Therefore, the aim of this study is to investigate the effect of lifestyle interventions combined with the GLP-1 receptor agonist semaglutide to young adults with otherwise treatment resistant obesity.

Methods and analysis: This is an investigator-initiated, randomized, placebo-controlled trial. We will recruit 130-170 young adults (age 18-28) from The Children's Obesity Clinic (TCOC), Department of Pediatrics, Holbæk Hospital. Based on their previous response to the TCOC protocol we will divide them in three groups:

Group A: Non-responders: 55-75 young adults (BMI>30 kg/m2) who have not succeeded in losing weight during the structured lifestyle intervention (BMI SDS reduction <0.1) Group B: Insufficient responders: 55-75 young adults (BMI>30 kg/m2) who have succeeded in losing weight during the structured lifestyle intervention (BMI SDS reduction >0.25), but still have obesity.

Group C: Excellent responders: 20 young adults, who have succeeded in losing weight during the structured lifestyle intervention (BMI SDS reduction >0.5) and no longer have obesity (BMI<30 kg/m2).

Group A and B are randomized 2:1 to either semaglutide or placebo for 68 weeks. Group C will attend baseline examinations only and not undergo intervention. The primary endpoint is change in BMI from randomization to end-of-treatment.

Ethics and dissemination: The trial has been approved by the Danish Medicines Agency (EudraCT 2019-002274-31) and by the ethical committee of the Capital Region of Denmark (H-20039422). The trial will be conducted in agreement with the Declaration of Helsinki and monitored to follow the guidelines for good clinical practice. Results will be submitted for publication in international peer-reviewed scientific journals.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Signe Torekov
• Collaborators: Holbaek Sygehus; Karolinska Institutet; Rigshospitalet, Denmark; University of Leeds

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.