DelfaGLP-1 Atlas

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RESETTLE

CompletedPhase 4

Young Adults With Early-onset Obesity Treated With Semaglutide

Young Adults With Early-onset Obesity Treated With Semaglutide -The RESETTLE Study

Lead sponsor

Signe Torekov

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

2

Recruiting sites

—

Enrollment

246

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoint

•BMI, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05574439
Org study IDU1111-1215-8606
Secondary ID2019-002274-31

Timeline

Milestones

Study start2022-06-01actual
Study first posted2022-10-10actual
Primary completion2026-04-01actual
Study completion2026-04-01actual
Last update posted2026-05-04actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age28 Years
SexAll
Healthy volunteersAccepted

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)

Endpoints (54)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
18
Other (unclassified)
13
Cardiometabolic biomarkers
8
Patient-reported / QoL
6
Glycemic / diabetes
5
Other clinical outcomes
4

Weight & body composition

18 endpoints
Primary/protocol endpoint

Change in BMI (weight in kg/height in m^2)

Time frame:Change from baseline to end-of-treatment (68 weeks)

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in body composition (fat mass)

Time frame:Change from baseline to end-of-treatment (68 weeks)

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Change in body composition (fat percentage)

Time frame:Change from baseline to end-of-treatment (68 weeks)

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Change in body composition (fat free mass)

Time frame:Change from baseline to end-of-treatment (68 weeks)

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Change in visceral fat and liver fat

Time frame:Change from baseline to end-of-treatment (68 weeks)

Visceral fat, change

change from baseline, improvement

componentsVisceral fat, change, Liver fat content, change

Secondary/protocol endpoint

Change in waist-to-height ratio

Time frame:Change from baseline to end-of-treatment (68 weeks)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Compare BMI (weight in kg/height in m^2), body composition, body weight, and metabolic health between population-based reference group, excellent responders, non-responders and insufficient responders.

Time frame:Baseline comparison and change from baseline to end-of-treatment (68 weeks)

change from baseline, improvement

componentsBMI, change, Total fat mass, Lean mass, Body weight, absolute change (kg)

Secondary/protocol endpoint

Change in body weight

Time frame:Change from baseline to end-of-treatment (68 weeks)

Body weight, absolute change (kg)

change from baseline, improvement

Other/protocol endpoint

Waist and hip circumference

Time frame:Baseline comparison and change from baseline to end-of-treatment (68 weeks)

Waist circumference, change

change from baseline, improvement

Other/protocol endpoint/low confidence

Ectopic fat accumulation in liver, viscera and muscle

Time frame:Baseline comparison and change from baseline to end-of-treatment (68 weeks)

change from baseline, improvement

componentsVisceral fat, change, Liver fat content, change

Other/protocol endpoint

Bone mineral density

Time frame:Baseline comparison and change from baseline to end-of-treatment (68 weeks)

change from baseline, descriptive

Other/protocol endpoint/low confidence

Muscle Strength

Time frame:Change from 68 weeks to week 94

change from baseline, improvement

Other/protocol endpoint

Change in body composition after medication (fat percentage)

Time frame:Week 68 to 94

Total fat mass

change from baseline, improvement

Other/protocol endpoint

Change in body composition after medication (fat mass)

Time frame:Week 68 to 94

Total fat mass

change from baseline, improvement

Other/protocol endpoint

Change in body composition after medication (fat-free mass)

Time frame:Week 68 to 94

Lean mass

change from baseline, improvement

Other/protocol endpoint

Change in body weight after medication

Time frame:Change from week 68 to 94

Body weight, absolute change (kg)

change from baseline, improvement

Other/protocol endpoint

Change in waist-to-height ratio after medication

Time frame:Change from week 68 to 94

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in visceral fat and liver fat after medication

Time frame:Change from week 68 to 94

change from baseline, improvement

Glycemic / diabetes

5 endpoints
Other/protocol endpoint

HOMA-IR

Time frame:Baseline comparison and change from baseline to end-of-treatment (68 weeks)

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Other/protocol endpoint

Matsuda Index

Time frame:Baseline comparison and change from baseline to end-of-treatment (68 weeks)

change from baseline, improvement

Other/protocol endpoint

Plasma Glucose

Time frame:Baseline comparison and change from baseline to end-of-treatment (68 weeks)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Other/protocol endpoint

Plasma Insulin

Time frame:Baseline comparison and change from baseline to end-of-treatment (68 weeks)

change from baseline, improvement

Other/protocol endpoint

HbA1c

Time frame:Baseline comparison and change from baseline to end-of-treatment (68 weeks)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

8 endpoints
Secondary/protocol endpoint

Change in metabolic syndrome

Time frame:Change from baseline to end-of-treatment (68 weeks)

categorical status, improvement

Other/protocol endpoint

Lipids

Time frame:Baseline comparison and change from baseline to end-of-treatment (68 weeks)

change from baseline, improvement

Other/protocol endpoint

Free Fatty Acids

Time frame:Baseline comparison and change from baseline to end-of-treatment (68 weeks)

Free fatty acids, change

change from baseline, improvement

Other/protocol endpoint

Blood pressure

Time frame:Baseline comparison and change from baseline to end-of-treatment (68 weeks)

change from baseline, improvement

Other/protocol endpoint

Heart rate

Time frame:Baseline comparison and change from baseline to end-of-treatment (68 weeks)

Heart rate, change

change from baseline, improvement

Other/protocol endpoint/low confidence

Hormonal appetite regulation during meal tests and in fasting

Time frame:Baseline comparison and change from baseline to end-of-treatment (68 weeks)

change from baseline, improvement

Other/protocol endpoint

Systemic biomarkers of inflammation

Time frame:Baseline comparison and change from baseline to end-of-treatment (68 weeks)

change from baseline, improvement

Other/protocol endpoint

Immunometabolic profile of subcutaneous adipose tissue

Time frame:Baseline comparison and change from baseline to end-of-treatment (68 weeks)

change from baseline, improvement

Patient-reported / QoL

6 endpoints
Other/protocol endpoint

Food preferences

Time frame:Baseline comparison and change from baseline to end-of-treatment (68 weeks)

change from baseline, improvement

Other/protocol endpoint

Subjective appetite sensation

Time frame:Baseline comparison and change from baseline to end-of-treatment (68 weeks)

change from baseline, improvement

Other/protocol endpoint

Health-related quality of life

Time frame:Change from baseline to end-of-treatment (68 weeks)

SF-36 total

change from baseline, improvement

Other/protocol endpoint

Eating behavior

Time frame:Baseline comparison and change from baseline to end-of-treatment (68 weeks)

change from baseline, improvement

Other/protocol endpoint

Health-related quality of life after medication

Time frame:Change from week 68 to 94

SF-36 total

change from baseline, improvement

Other/protocol endpoint

Sleep quality

Time frame:Baseline comparison and changes from baseline to end-of-treatment (week 68)

change from baseline, improvement

Other clinical outcomes

4 endpoints
Other/protocol endpoint/low confidence

Brain structure and function

Time frame:Baseline comparison and change from baseline to end-of-treatment (68 weeks)

change from baseline, descriptive

Other/protocol endpoint/low confidence

Physical activity level

Time frame:Baseline comparison and changes from baseline to end-of-treatment (week 68)

change from baseline, improvement

Other/protocol endpoint

Sleep

Time frame:Baseline comparison and changes from baseline to end-of-treatment (week 68)

change from baseline, improvement

Other/protocol endpoint

Physical activity level

Time frame:Baseline comparison and changes from baseline to end-of-treatment (week 68)

change from baseline, improvement

Other (unclassified)

13 endpoints
Secondary/protocol endpoint/low confidence

Change in metabolic syndrome

Time frame:Change from baseline to end-of-treatment (68 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

Bone markers

Time frame:Baseline comparison and change from baseline to end-of-treatment (68 weeks)

change from baseline, descriptive

Other/protocol endpoint/low confidence

Systemic biomarkers of oxidation

Time frame:Baseline comparison and change from baseline to end-of-treatment (68 weeks)

change from baseline, improvement

Other/protocol endpoint/low confidence

RNA sequencing on subcutaneous adipose tissue

Time frame:Baseline comparison and change from baseline to end-of-treatment (68 weeks)

descriptive

Other/protocol endpoint/low confidence

Genetic risk score correlated to treatment response

Time frame:Baseline comparison and change from baseline to end-of-treatment (68 weeks)

descriptive

Other/protocol endpoint/low confidence

Gut microbiota composition

Time frame:Baseline comparison and change from baseline to end-of-treatment (68 weeks)

change from baseline, descriptive

Other/protocol endpoint/low confidence

Metabolomics in urine

Time frame:Baseline comparison and change from baseline to end-of-treatment (68 weeks)

descriptive

Other/protocol endpoint/low confidence

Metabolomics in plasma

Time frame:Baseline comparison and change from baseline to end-of-treatment (68 weeks)

descriptive

Other/protocol endpoint/low confidence

Proteomics in plasma

Time frame:Baseline comparison and change from baseline to end-of-treatment (68 weeks)

change from baseline, descriptive

Other/protocol endpoint/low confidence

Psycho-social aspects of obesity development and treatment response by qualitative content analysis of semi-structured interviews

Time frame:Baseline comparison and change from baseline to end-of-treatment (68 weeks)

descriptive

Other/protocol endpoint/low confidence

Systemic levels of metabolic disruptors

Time frame:Change from baseline to end-of-treatment (68 weeks)

concentration, descriptive

Other/protocol endpoint/low confidence

Induction of pluripotent stem cell cultures (iPSC)

Time frame:Baseline comparison

descriptive

Other/protocol endpoint/low confidence

Change in metabolic syndrome after medication

Time frame:Change from week 68 to 94

change from baseline, improvement

Publications (23)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.