DelfaGLP-1 Atlas

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CompletedPhase 1

A Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Obese Children Aged 7 to 11 Years

A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Obese Children Aged 7 to 11 Years

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

9

Recruiting sites

—

Enrollment

24

actual

Study population

Obesity / overweight

Key I/E criterion

•Age 7-11

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 IDNCT02696148
Org study IDNN8022-4181
Secondary ID2014-004454-34
Secondary IDU1111-1162-9171WHO

Timeline

Milestones

Study first posted2016-03-02estimated
Study start2016-03-14actual
Primary completion2017-04-13actual
Study completion2017-04-13actual
Last update posted2019-03-18actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age7 Years
Maximum age11 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Male or female subjects aged 7-11 years (both inclusive) at the time of signing informed consent
•Tanner stage 1 (including subjects with premature adrenarche) at the time of signing informed consent
•BMI (body mass index) corresponding to above or equal to 30 kg/m^2 for adults by international cut-off points (Cole et al 2000)1 and BMI below or equal to 45 kg/m^2 as well as BMI above or equal to 95th percentile for age and gender

Exclusion criteria

•Subjects with secondary causes of childhood obesity (i.e., hypothalamic, genetic or endocrine causes)
•Subjects with confirmed bulimia nervosa disorder
•Diagnosis of type 1 diabetes mellitus or type 2 diabetes mellitus as defined by glycosylated haemoglobin (HbA1C) Above or equal to 6.5 %
•History of pancreatitis (acute or chronic)
•Presence of severe co-morbidities as judged by the investigator
•Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid carcinoma (MTC)
•History of major depressive disorder within 2 years before randomisation

Endpoints (2)

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

2 endpoints
Primary/protocol endpoint

Number of treatment emergent adverse events

Time frame:From the time of first dosing and until completion of follow-up visit (59-108 days after first dosing)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Area under the liraglutide concentration curve

Time frame:From 0-24 hours at steady state following the last dose (49-91 days after first dosing)

AUC₀–∞

concentration, 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.