Young Adults with Early-onset Obesity Treated with Semaglutide

Launched by SIGNE TOREKOV · Oct 6, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called semaglutide combined with lifestyle changes to help young adults aged 18-28 who struggle with obesity. Many adolescents do not see improvements with typical weight loss programs, so researchers are looking for new, effective treatments. The trial will involve 180-270 participants divided into different groups based on their previous weight loss success. Some participants will receive semaglutide, while others will receive a placebo (a treatment that looks the same but contains no active medication) for 68 weeks.

To be eligible for the trial, participants must be between 18 and 28 years old and have a body mass index (BMI) of 30 or higher if they didn’t lose weight with previous programs, or have lost some weight but still have obesity. Participants will be monitored closely throughout the study to see how their BMI changes. It's important to note that individuals with certain medical conditions or who are pregnant cannot join the trial. This study has been approved by health authorities and aims to provide valuable insights into treating obesity in young adults.

Gender

ALL

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 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.
• • 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.
• • 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.
• • Group D: Young adults who have participated in The Holbaek Study and have had normal weight development during childhood
• 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
• • Severe 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.
• • 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)