GLP-1 Peptide Atlas, by Delfa

TerminatedPhase 1

A Research Study to Compare Two Forms of Semaglutide in Two Different Pen-injectors in People With Overweight or Obesity

A Trial to Demonstrate Bioequivalence Between Semaglutide Formulations With the DV3396 Pen-injector and With the PDS290 Pen-injector in Subjects With Overweight or Obesity

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI 27-34.9

Primary endpoints

•AUC0-168h,2.4mg,SS•Cmax,2.4mg,SS

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 IDNCT04012255

Org study IDNN9536-4475

Secondary ID2018-003923-13European Medicines Agency (EudraCT)

Secondary IDU1111-1221-9644World Health Organization (WHO)

Timeline

Milestones

Study first posted2019-07-09actual

Study start2019-07-15actual

Primary completion2019-08-30actual

Study completion2019-10-22actual

Last update posted2019-10-23actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent

•Body mass index (BMI) between 27.0 and 34.9 kg/m^2 (both inclusive)

•Body weight between 70.0 and 130.0 kg (both inclusive)

Exclusion criteria

•Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method

•Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol

•Inability or unwillingness to perform self-injection

Endpoints (12)

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

Safety / tolerability / PK

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change in body weight

Time frame:From baseline (Day 1, pre-dose) until the end of treatment (Day 148)

Body weight, % change

percent change from baseline, improvement

Safety / tolerability / PK

11 endpoints

Primary/protocol endpoint

AUC0-168h,2.4mg,SS: Area under the semaglutide concentration time curve following the last administration of semaglutide s.c. 2.4 mg

Time frame:0-168 hours (Day 141-148) after last 2.4 mg dose

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Cmax,2.4mg,SS: Maximum observed semaglutide concentration following the last administration of semaglutide s.c. 2.4 mg

Time frame:0-168 hours (Day 141-148) after last 2.4 mg dose

Cmax

concentration, descriptive

Secondary/protocol endpoint

AUC0-168h,1mg,SS: Area under the semaglutide concentration time curve following the last administration of semaglutide s.c. 1 mg

Time frame:0-168 hours (Day 78-85) after last 1 mg dose

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,1mg,SS: Maximum observed semaglutide concentration following the last administration of semaglutide s.c. 1 mg

Time frame:0-168 hours (Day 78-85) after last 1 mg dose

Cmax

concentration, descriptive

Secondary/protocol endpoint

Tmax,2.4mg,SS: Time of maximum observed semaglutide concentration after last 2.4 mg dose

Time frame:0-168 hours (Day 141-148) after last 2.4 mg dose

Tmax

concentration, descriptive

Secondary/protocol endpoint

Tmax,1mg,SS: Time of maximum observed semaglutide concentration after last 1 mg dose

Time frame:0-168 hours (Day 78-85) after last 1 mg dose

Tmax

descriptive

Secondary/protocol endpoint

t½: Terminal elimination half-life of semaglutide after last 2.4 mg dose

Time frame:0-1176 hours (Day 141-190) after last 2.4 mg dose

Half-life

descriptive

Secondary/protocol endpoint

Cl/F2.4mg: Total apparent clearance of semaglutide after last 2.4 mg dose

Time frame:0-168 hours (Day 141-148) after last 2.4 mg dose

descriptive

Secondary/protocol endpoint

Cl/F1mg: Total apparent clearance of semaglutide after last 1 mg dose

Time frame:0-168 hours (Day 78-85) after last 1 mg dose

descriptive

Secondary/protocol endpoint

Vss/F2.4mg: Apparent volume of distribution at steady-state of semaglutide after last 2.4 mg dose

Time frame:0-168 hours (Day 141-148) after last 2.4 mg dose

descriptive

Secondary/protocol endpoint

Vss/F1mg: Apparent volume of distribution at steady-state of semaglutide after last 1 mg dose

Time frame:0-168 hours (Day 78-85) after last 1 mg dose

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.