DelfaGLP-1 Atlas

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CompletedPhase 1

A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability and Pharmacokinetics of Liraglutide in Obese Adolescent Subjects Aged 12 to 17 Years

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

21

actual

Study population

Obesity / overweight

Key I/E criterion

•Age 12-17

Primary endpoint

•Treatment-emergent AEs (any)

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 IDNCT01789086
Org study IDNN8022-3967
Secondary ID2012-000038-20
Secondary IDU1111-1126-8119WHO

Timeline

Milestones

Study first posted2013-02-11estimated
Last update posted2016-12-22estimated
Study start2013-02 (month precision)
Primary completion2014-05actual (month precision)
Study completion2014-05actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age12 Years
Maximum age17 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Subjects with Tanner stage 2-5 pubertal development at time of randomisation
•Body Mass Index (BMI) corresponding to 30 kg/m^2 or above for adults by international cut-off points and 45 kg/m^2 or below and equal to or above 95th percentile for age and gender
•Fasting plasma glucose below 7.0 mmol/L (126 mg/dL) (central laboratory analysis)

Exclusion criteria

•Subjects with clinically diagnosed secondary causes of childhood obesity such as chromosomal abnormalities (e.g. Turner syndrome), syndromic obesity (e.g. Prader Willi syndrome) or endocrinologic disorders (e.g. Cushing Syndrome)
•Subjects with confirmed diagnosis of bulimia
•Subjects with Tanner stage 1 development (prepubertal)
•Diagnosis of type 1 or type 2 diabetes mellitus as judged by the investigator
•Previous treatment with a GLP-1 (glucagon-like peptide 1) receptor agonists (e.g. exenatide or liraglutide or other), DPP-4 (dipeptidyl peptidase-4) inhibitors, orlistat or other weight lowering medication, any antipsychotic medication or systemic corticosteroids within the last 3 months
•Currently using or have used within 3 months before screening for this trial: any systemic treatment that in the opinion of the investigator interferes with PK (pharmacokinetic), PD (pharmacodynamic) and safety endpoints
•Surgical treatment for obesity
•Past or current chronic or idiopathic pancreatitis, or any of the following: -amylase or lipase above 2 times UNR (upper normal range), -triglycerides above 500 mg/dL, -calcium above UNR, -history of gallstones (not treated by cholecystectomy)
•Uncontrolled treated or untreated hypertension 99th percentile for age and gender in children
•History of major depressive disorder or history of other severe psychiatric disorders (e.g. schizophrenia or bipolar disorder) that could in the opinion of the investigator interfere with trial compliance or subject safety
•Subjects with a history of suicide attempts or history of any suicidal behaviour within the past month before entry into the trial

Endpoints (7)

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.

Safety / tolerability / PK

7 endpoints
Primary/protocol endpoint

Number of treatment emergent adverse events (TEAEs)

Time frame:From the time of first dosing (Day 0) and until completion of follow-up visit (up to 6 weeks' treatment and 5-14 days subsequent follow-up period)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Incidence of liraglutide antibody

Time frame:At follow-up (up to 6 weeks' treatment and 5-14 days subsequent follow-up period)

Immunogenicity (ADA)

threshold achievement, event

Secondary/protocol endpoint

At steady state at each dose step: C-trough

Time frame:After 7, 14, 21, 28 and 35 days of treatment

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

At steady-state: model-derived area under the liraglutide concentration curve over the dosing

Time frame:Last dose day, after up to 6 weeks' treatment

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

At steady-state: model-derived t½ (terminal half-life)

Time frame:Last dose day, after up to 6 weeks' treatment

Half-life

descriptive

Secondary/protocol endpoint

At steady-state: model-derived CL/F (apparent clearance)

Time frame:Last dose day, after up to 6 weeks' treatment

descriptive

Secondary/protocol endpoint

At steady-state: model-derived V/F (apparent volume of distribution)

Time frame:Last dose day, after up to 6 weeks' treatment

descriptive

Publications (1)

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.