DelfaGLP-1 Atlas

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CompletedPhase 1

First Research Study to Look at How Two Medicines, NNC0480-0389 and Semaglutide, Work Together in Healthy People, in People With High Body Weight and in People With Diabetes

Investigation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of NNC0480-0389 in Combination With Semaglutide s.c.

Lead sponsor

Novo Nordisk A/S

Assets

NNC0480-0389 / Semaglutide

Listed sites

1

Recruiting sites

—

Enrollment

152

actual

Study population

Healthy volunteers, Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 20-29.9•Healthy volunteers

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 IDNCT04259801
Org study IDNN9389-4536
Secondary ID2019-002857-44European Medicines Agency (EudraCT)
Secondary IDU1111-1236-4114World Health Organization (WHO)

Timeline

Milestones

Study first posted2020-02-06actual
Study start2020-02-17actual
Primary completion2022-03-16actual
Study completion2022-03-16actual
Last update posted2023-11-13actual

Assets

Investigational agents

NNC0480-0389Semaglutide

Study populations

Who this study enrolls

Healthy volunteersObesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age64 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

Part 1:

•Male aged 18-45 years (both inclusive) at the time of signing informed consent.
•Body mass index between 20.0 kg/m^2 and 29.9 kg/m^2 (both inclusive).
•Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Part 2 (not applicable for proof-of-concept (PoC) cohort):

•Body mass index between 20.0 kg/m^2 and 39.9 kg/m^2 (both inclusive).
•Female of non-childbearing potential or male aged 18-55 years (both inclusive) at the time of signing informed consent.
•Considered to be eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Part 2 (only applicable for PoC cohort):

•Body mass index between 25.0 kg/m^2 and 39.9 kg/m^2 (both inclusive). Overweight or obesity should be due to excess adipose tissue, as judged by the investigator.
•Female of non-childbearing potential or male aged 18-64 years (both inclusive) at the time of signing informed consent.
•Considered to be eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
•Diagnosed with type 2 diabetes at least 90 days prior to the day of screening.
•Subjects treated with diet and exercise as monotherapy or in combination with 1-2 of the following anti-diabetic drug(s) at a stable dose for at least 30 days prior to screening: metformin, sulfonylureas, meglitinides, DPP-4 inhibitors, alpha-glucosidase inhibitors, thiazolidinediones, GLP-1 receptor agonists or SLGT-2 inhibitors. The metformin dose should be between 1500 mg to 3000 mg or maximum tolerated or effective dose documented in subject's medical record.
•Glycosylated haemoglobin (HbA1c) in the range of 6.5% (inclusive) and 10% (non-inclusive).

Exclusion criteria

Part 1:

•Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
•HbA1c equal to or above 6.5 % (48 mmol/mol) at screening.
•Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation within 14 days prior to the day of screening. Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.

Part 2 (not applicable for PoC cohort):

•Any disorder (except for conditions associated with T2D for the PoC cohort) which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
•Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions (except conditions associated with T2D for PoC Cohort).
•Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation within 14 days prior to the day of screening.
•HbA1c equal to or above 6.5 % (48 mmol/mol) at screening.

Part 2 (only applicable for PoC cohort):

•Any disorder (except for conditions associated with T2D for the PoC cohort) which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
•Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions (except conditions associated with T2D for PoC Cohort).
•Use of any prohibited medications as listed in the protocol within 14 days of screening.
•Use of prescribed medications at the time of screening at a dose that had not been stable within 30 days prior to screening.

Endpoints (10)

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

10 endpoints
Primary/protocol endpoint

Number of treatment emergent adverse events (TEAE) in Part 1

Time frame:From time of dosing (day 1) until completion of follow-up visit (day 71)

Treatment-emergent AEs (any)

event count, event

Primary/protocol endpoint

Number of treatment emergent adverse events (TEAE) in Part 2

Time frame:From first combination dosing (day 57) until completion of follow-up visit (day 148)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Area under the NNC0480-0389 plasma concentration-time curve from time

Time frame:From baseline (day 1) to post treatment follow-up (day 71)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum plasma concentration of NNC0480-0389 after administration of a single dose

Time frame:From baseline (day 1) to post treatment follow-up (day 71)

Cmax

concentration, descriptive

Secondary/protocol endpoint

Area under the semaglutide plasma concentration time curve from time of dosing to infinity after administration of a single dose

Time frame:From baseline (day 1) to post treatment follow-up (day 71)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

The maximum concentration of semaglutide after administration of a single dose

Time frame:From baseline (day 1) to post treatment follow-up (day 71)

Cmax

concentration, descriptive

Secondary/protocol endpoint

Area under the NNC0480-0389 plasma concentration-time curve from 0 to 168 hours after administration of the 4th dose of NNC0480-0389 in week 12

Time frame:From administration of dose in week 12 (day 78) to day 85

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum plasma concentration of NNC0480-0389 after administration of the 4th dose of NNC0480-0389 in week 12

Time frame:From administration of dose in week 12 (day 78) to post treatment follow-up (day 148)

Cmax

concentration, descriptive

Secondary/protocol endpoint

Area under the semaglutide plasma concentration-time curve from 0-168 hours after administration of the 12th dose of semaglutide

Time frame:From administration of dose in week 12 (day 78) to day 85

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

The maximum concentration of semaglutide after administration of the 12th dose of semaglutide

Time frame:From administration of dose in week 12 (day 78) to post treatment follow-up (day 148)

Cmax

concentration, 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.