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

Kobenhavns Universitet1 site in 1 country255 target enrollmentOctober 2, 2024

DrugsNNC0113-0217 SEMAGLUTIDE

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Not specified
Sponsor: Kobenhavns Universitet
Enrollment: 255
Locations: 1
Primary Endpoint: Primary endpoints (change from V1 to V2) Change in BMI (weight in kg/(height in m)2) from before to after GLP-1 RA compared to placebo.
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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 2.4mg for 68 weeks. B) To treat young adults with childhood-onset obesity, who have responded with insufficient weight loss to the structured lifestyle intervention (TCOC protocol) and remain obese, with the same GLP-1 RA, semaglutide 2.4mg for 68 weeks. C) To identify underlying mechanisms of lifestyle-untreatable versus treatable childhood-onset obesity.

Registry

euclinicaltrials.eu

Start Date

October 2, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Kobenhavns Universitet

Responsible Party

Principal Investigator

Signe Torekov

Scientific

Kobenhavns Universitet

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≥
•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≥
•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<
•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.

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)
•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 hydrogen phosphate dihydrate, hydrogen chloride, sodium chloride, sodium hydroxide and water for injection.
•Exclusion criteria for MRI: e.g., pacemaker, claustrophobia, etc.
•Angina pectoris, coronary heart disease, congestive heart failure (NYHA III-IV)
•Severe renal impairment (creatinine clearance (GFR) <30 mL/min)

Outcomes

Primary Outcomes

Primary endpoints (change from V1 to V2) Change in BMI (weight in kg/(height in m)2) from before to after GLP-1 RA compared to placebo.

Secondary Outcomes

Secondary endpoints (change from V1 to V2) 1) Body composition 2) Body weight change 3) Participants with a reduction in body weight of at least 5%, 10%, 15%, and 20%