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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Kobenhavns Universitet

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Phenomena and Processes [G] - Metabolism [G03]

Trial duration

2 Oct 2025 → 1 Apr 2026

Decision date (initial)

2024-10-02

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Novo Nordisk Foundation (Grant agreement no. NNF20SA0064340) · Lundbeck Foundation (R366-2021-249) · Novo Nordisk

External identifiers

EU CT number

2024-518086-99-00

EudraCT number

2019-002274-31

WHO UTN

U1111-1215-8606

ClinicalTrials.gov

NCT00227431

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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.

Conditions and MedDRA coding

Obesity

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. • Age 18-28 years
2. The period from the initial treatment with TCOC protocol until inclusion in the study must be within 15 years.
3. 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).
4. 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).
5. 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).
6. Only baseline examination: Group D: Young adults who have participated in The Holbaek Study and have had normal weight development during childhood.

Exclusion criteria 16

1. Participants diagnosed with known serious chronic illness including type 1 or 2 diabetes (or a randomly measured fasting plasma glucose > 7 mmol/l)
2. Angina pectoris, coronary heart disease, congestive heart failure (NYHA III-IV)
3. Severe renal impairment (creatinine clearance (GFR) <30 mL/min)
4. Severe hepatic impairment
5. Inflammatory bowel disease
6. Diabetic gastroparesis
7. Cancer
8. Chronic obstructive lung disease
9. Severe psychiatric disease, a history of major depressive or other serious psychiatric disorders
10. Use of medications causing clinically significant weight gain or loss
11. Previous bariatric surgery
12. A history of idiopathic acute pancreatitis
13. A family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma
14. 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).
15. 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.
16. Exclusion criteria for MRI: e.g., pacemaker, claustrophobia, etc.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 1

1. 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%

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Kobenhavns Universitet

Sponsor organisation

Kobenhavns Universitet

Address

Blegdamsvej 3b

City

Copenhagen N

Postcode

2200

Country

Denmark

Scientific contact point

Organisation

Kobenhavns Universitet

Contact name

Signe Torekov

Public contact point

Organisation

Kobenhavns Universitet

Contact name

Signe Torekov

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications