DelfaGLP-1 Atlas

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CompletedPhase 1

A Research Study Looking at the Comparability (Bioequivalence) of Two Versions of Semaglutide

A Trial to Demonstrate Bioequivalence Between Semaglutide Drug Product Concentrations 0.68 mg/mL and 1.0 mg/mL

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

28

actual

Study population

Healthy volunteers

Key I/E criterion

•BMI 20-27

Primary endpoints

•Area under the semaglutide plasma concentration curve from 0 to tz•Maximum semaglutide plasma concentration

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 IDNCT04228354
Org study IDNN9536-4649
Secondary ID2019-004020-37European Medicines Agency (EudraCT)
Secondary IDU1111-1241-6257World Health Organization (WHO)

Timeline

Milestones

Study first posted2020-01-14actual
Study start2020-01-29actual
Primary completion2020-06-01actual
Study completion2020-06-01actual
Last update posted2022-01-10actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent.
•Body mass index between 20.0 and 27.0 kg/m^2 (both inclusive).

Exclusion criteria

•Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods.
•Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.

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

Area under the semaglutide plasma concentration curve from 0 to tz

Time frame:0-840 hours

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Maximum semaglutide plasma concentration

Time frame:0-840 hours

Cmax

concentration, descriptive

Secondary/protocol endpoint

Area under the semaglutide plasma concentration curve

Time frame:0-840 hours

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Time to Cmax for semaglutide

Time frame:0-840 hours

Tmax

descriptive

Secondary/protocol endpoint

Terminal elimination half-life

Time frame:0-840 hours

Half-life

descriptive

Secondary/protocol endpoint

Total apparent clearance of semaglutide

Time frame:0-840 hours

descriptive

Secondary/protocol endpoint

Apparent volume of distribution of semaglutide

Time frame:0-840 hours

descriptive

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.