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

Phase 4

Not yet recruiting

Conditions: Obesity

Registration Number: 2024-518086-99-00

Lead Sponsor: Kobenhavns Universitet

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised, recruitment pending

Sex: Not specified

Target Recruitment: 255

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 (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).

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)

Severe hepatic impairment

Inflammatory bowel disease

Diabetic gastroparesis

Cancer

Chronic obstructive lung disease

Severe psychiatric disease, a history of major depressive or other serious psychiatric disorders

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.		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 Outcome Measures

Name	Time	Method
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%		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%

Trial Locations

Locations (1): Kobenhavns Universitet
🇩🇰
Copenhagen N, Denmark
Kobenhavns Universitet
🇩🇰Copenhagen N, Denmark
Sarah Byberg
Site contact
004535327509
sarah.byberg@sund.ku.dk

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