DelfaGLP-1 Atlas

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CompletedPhase 1

Investigating the Pharmacokinetics, Safety and Tolerability After a Single Subcutaneous Injection of Semaglutide in Subjects With Mild, Moderate or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function

A Multi-centre, Open-label, Parallel-group Trial Investigating the Pharmacokinetics, Safety and Tolerability After a Single Subcutaneous Injection of Semaglutide in Subjects With Mild, Moderate or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

4

Recruiting sites

—

Enrollment

44

actual

Study population

Healthy volunteers, Hepatic impairment

Key I/E criterion

•BMI 18.5-40

Primary endpoint

•AUC of semaglutide

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 IDNCT02210871
Org study IDNN9535-3651
Secondary ID2009-011673-33
Secondary IDU1111-1149-3924WHO

Timeline

Milestones

Study first posted2014-08-07estimated
Study start2014-08-07actual
Primary completion2015-06-03actual
Study completion2015-06-03actual
Last update posted2017-12-21actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Healthy volunteersHepatic impairment

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Male or female, age at least 18 years at the time of signing informed consent
•Body mass index (BMI) 18.5-40.0 kg/m^2 (both inclusive)
•Only for subjects with hepatic impairment (mild, moderate and severe): A diagnosis of cirrhosis due to parenchymal liver disease, classified as Child-Pugh grade A,B or C as assessed by investigator and which is confirmed and documented by medical history, physical examination and at least one of the following: hepatic ultrasound,computerised axial tomography (CT) scan, magnetic resonance imaging (MRI), and/or liver biopsy
•Only for subjects with normal hepatic function: Subjects who are judged to be in good general health based on physical examination, medical history, ECG, vital signs, and the results of biochemistry, coagulation, haematology tests and urinalysis performed during the screening visit, as judged by the investigator

Exclusion criteria

•Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential not using an adequate contraceptive method throughout the trial including the follow-up period (adequate contraceptive measures as required by local regulation or practice)
•Uncontrolled hypertension (defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg). If white-coat hypertension is suspected at the screening visit a repeated measurement at the screening visit is allowed
•Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with trial procedures
•Donation of any blood or plasma in the past month or in excess of 400 mL within the 3 months preceding screening, or surgery or trauma with more than 400 mL blood loss within the 3 months preceding screening

Endpoints (3)

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

3 endpoints
Primary/protocol endpoint

Area under the semaglutide plasma concentration-time curve

Time frame:Day 1 - day 36

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum observed semaglutide plasma concentration

Time frame:Day 1 - day 36

Cmax

concentration, descriptive

Secondary/protocol endpoint

Number of treatment emergent adverse events (TEAEs)

Time frame:Day 1 - day 36

Treatment-emergent AEs (any)

event count, event

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.