DelfaGLP-1 Atlas

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S-LITE

UnknownPhase 4

Combined Effects of GLP-1 Analogue and Exercise on Maintenance of Weight Loss and Health After Very-low Calorie Diet

Synergy Effect of the Appetite Hormone GLP-1 (LiragluTide) and Exercise on Maintenance of Weight Loss and Health After a Low Calorie Diet - the S-LiTE Randomized Trial

Lead sponsor

Signe Torekov

Assets

GLP-1 / incretin class catch-all / Liraglutide

Listed sites

1

Recruiting sites

—

Enrollment

215

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI 32-43

Primary endpoint

•Body weight, absolute change (kg)

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 IDNCT04122716
Org study IDU 1111-1173-3104 (UTN)
Secondary ID2015-005585-32
Secondary IDH-16027082The Ethical Committee of the Capital Region of Denmark

Timeline

Milestones

Study first posted2019-10-10actual
Last update posted2020-11-02actual
Study start2016-09actual (month precision)
Primary completion2019-11actual (month precision)
Study completion2021-11estimated (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-allLiraglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•BMI > 32 and < 43 (kg/m2)
•Age >18 and <65 years
•Safe contraceptive method

Exclusion criteria

•Patients 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
•Gastroparesis
•Cancer
•Chronic obstructive lung disease
•Psychiatric disease, a history of major depressive or other severe psychiatric disorders
•The use of medications that cause 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
•Osteoarthritis which is judged to be too severe to manage the exercise programme. As intended per study design the intervention will include a 5% weight loss prior to randomization, thus it is expected that possible participants with mild form of osteoarthritis will be able to manage exercise prescriptions.
•Pregnancy, expecting pregnancy or breast feeding. If a study participant is in doubt whether she could be pregnant, a urine pregnancy test is performed. Females of childbearing potential who are not using adequate contraceptive methods (as required by local law or practice). Adequate contraception must be used throughout the study period and at least 65 hours after discontinuation of trial medication (65 hours corresponds to 5 times the half-life of Saxenda). Allergy to any of the ingredients/excipients.
•Allergy to any of the ingredients/excipients of the study medication: liraglutide, disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid, sodium hydroxide.
•Regular exercise training at high intensity (e.g. spinning) >2 hours per week.

Endpoints (28)

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
6
Cardiometabolic biomarkers
6
Other clinical outcomes
5
Other (unclassified)
4
Glycemic / diabetes
3
Patient-reported / QoL
3
Safety / tolerability / PK
1

Weight & body composition

6 endpoints
Primary/protocol endpoint

Body weight change (kg)

Time frame:Change from baseline to end-of-treatment (52 weeks)

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Body composition (fat percentage)

Time frame:Change from baseline to end-of-treatment (52 weeks)

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Body composition (fat mass and fat free mass)

Time frame:Change from baseline to end-of-treatment (52 weeks)

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Waist and hip circumference

Time frame:Change from baseline to end-of-treatment (52 weeks)

Waist circumference, change

change from baseline, improvement

Other/protocol endpoint/low confidence

Proportion of participants with % weight loss

Time frame:Change from screening to end-of-treatment (52 weeks)

threshold achievement, improvement

Other/protocol endpoint

Total weight loss

Time frame:Change from screening to end-of-treatment (52 weeks)

Body weight, % change

percent change from baseline, improvement

Glycemic / diabetes

3 endpoints
Secondary/protocol endpoint

HOMA-IR

Time frame:Change from baseline to end-of-treatment (52 weeks)

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Matsuda Index

Time frame:Change from baseline to end-of-treatment (52 weeks)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Hormonal regulation of blood glucose

Time frame:Change from baseline to end-of-treatment (52 weeks)

change from baseline, improvement

Cardiometabolic biomarkers

6 endpoints
Secondary/protocol endpoint

Lipids

Time frame:Change from baseline to end-of-treatment (52 weeks)

change from baseline, improvement

Secondary/protocol endpoint

Blood pressure

Time frame:Change from baseline to end-of-treatment (52 weeks)

change from baseline, improvement

Secondary/protocol endpoint

MetS (z-score)

Time frame:Change from baseline to end-of-treatment (52 weeks)

change from baseline, improvement

Other/protocol endpoint

Heart rate

Time frame:Change from screening to baseline to end-of-treatment (52 weeks)

Heart rate, change

change from baseline, improvement

Other/protocol endpoint

Endothelial function

Time frame:Change from screening to baseline to end-of-treatment (52 weeks)

change from baseline, improvement

Other/protocol endpoint

Systemic markers of immunometabolism

Time frame:Change from screening to baseline to end-of-treatment (52 weeks)

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Patient-reported / QoL

3 endpoints
Other/protocol endpoint

Quality of life score

Time frame:Change from baseline to end-of-treatment (52 weeks)

SF-36 total

change from baseline, improvement

Other/protocol endpoint/low confidence

Questionnaires

Time frame:Change from baseline to end-of-treatment (52 weeks)

change from baseline, improvement

Other/protocol endpoint

Food preferences/subjective appetite sensation

Time frame:Change from baseline to end-of-treatment (52 weeks)

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Other/protocol endpoint

Use of medication

Time frame:Change from screening to baseline to end-of-treatment (52 weeks)

descriptive

Other clinical outcomes

5 endpoints
Secondary/protocol endpoint

Metabolic Syndrome (yes/no)

Time frame:Change from baseline to end-of-treatment (52 weeks)

categorical status, improvement

Other/protocol endpoint

Physical fitness (ml/min/min)

Time frame:Change from baseline to end-of-treatment (52 weeks)

change from baseline, improvement

Other/protocol endpoint

Determination of daily physical activity/sleep

Time frame:Change from screening to baseline to end-of-treatment (52 weeks)

change from baseline, descriptive

Other/protocol endpoint

Bone health (Bone mineral density)

Time frame:Change from baseline to end-of-treatment (52 weeks)

change from baseline, improvement

Other/protocol endpoint

Spermatozoa

Time frame:Change from screening to baseline to end-of-treatment (52 weeks)

change from baseline, improvement

Other (unclassified)

4 endpoints
Other/protocol endpoint/low confidence

Fasting and meal-related hormonal response

Time frame:Change from baseline to end-of-treatment (52 weeks)

change from baseline, descriptive

Other/protocol endpoint/low confidence

Immunometabolic changes in the subcutaneous adipose tissue

Time frame:Change from screening to baseline to end-of-treatment (52 weeks)

change from baseline, descriptive

Other/protocol endpoint/low confidence

Faecal bacterial composition

Time frame:Change from screening to baseline to end-of-treatment (52 weeks)

descriptive

Other/protocol endpoint

Follow-up visit

Time frame:End-of-treatment to 1 year after intervention

descriptive

Publications (62)

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.