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CompletedPhase 1

First Research Study to Compare a Possible New Medicine NNC9204-1513 to the Medicine Glucagon, in Healthy People.

A Randomised, Double-blinded, Single Subcutaneous Dose Escalation Trial Investigating the Safety and Tolerability of NNC9204-1513 in Healthy Subjects

Lead sponsor

Novo Nordisk A/S

Asset

NNC9204-1513

Subcutaneous · Glucagon receptor agonist

Listed sites

1

Recruiting sites

-

Actual enrollment

36

Study population

Type 1 diabetes, Type 2 diabetes

Eligibility highlights

•BMI 18.5-28•Male•Healthy volunteers

Primary endpoint

•Number of treatment emergent adverse events (TEAEs)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03444467
Org study IDNN9513-4290
Secondary ID2016
Secondary ID2016-001173-33European Medicines Agency (EudraCT)
Secondary IDU1111-1180-8217World Health Organization (WHO)

Timeline

Milestones

Study start2018-02-05actual
Study first posted2018-02-23actual
Primary completion2018-05-24actual
Study completion2018-05-24actual
Last update posted2018-09-05actual

Assets

Investigational agents

NNC9204-1513

Who this study enrolls

Type 1 diabetesType 2 diabetes

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexMale
Healthy volunteersAccepted

Inclusion criteria

•Male, aged 18 -55 years (both inclusive), at the time of signing informed consent
•Body mass index (BMI) between 18.5 and 28.0 kg/sqm (both inclusive)
•Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion criteria

•Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol
•Smoker (defined as a subject who is smoking at least one cigarette or equivalent daily) who is not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
•Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening

Endpoints (27)

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
11
Other (unclassified)
9
Glycemic / diabetes
3
Cardiometabolic biomarkers
3
Other clinical outcomes
1

Glycemic / diabetes

3 endpoints
Secondary/protocol endpoint

Change from baseline in glucose metabolism

Time frame:baseline (day 1), follow-up visit (day 8)

change from baseline, improvement

Secondary/protocol endpoint

AUCPG,0-15min,SD, area under the plasma glucose time curve

Time frame:0 to 15 minutes after single dose

concentration, descriptive

Secondary/protocol endpoint

ΔPG0-15min,SD, Increase in plasma glucose concentration from 0 to 15 minutes

Time frame:0 to 15 minutes after single dose

concentration, descriptive

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint

Change from baseline in lipids

Time frame:baseline (day 1), follow-up visit (day 8)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in systolic- and diastolic blood pressure

Time frame:baseline (day 1), follow-up visit (day 8)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in 12-lead electrocardiogram (ECG) heart rate

Time frame:baseline (day 1), follow-up visit (day 8)

change from baseline, improvement

Safety / tolerability / PK

11 endpoints
Primary/protocol endpoint

Number of treatment emergent adverse events (TEAEs)

Time frame:from time of dosing (day 1) to completion of the safety follow-up visit (day 8)

event count, event

Secondary/protocol endpoint

Change from baseline in 12-lead ECG (RR interval)

Time frame:baseline (day 1), follow-up visit (day 8)

change from baseline, event

Secondary/protocol endpoint

Change from baseline in 12-lead ECG (PR interval)

Time frame:baseline (day 1), follow-up visit (day 8)

change from baseline, event

Secondary/protocol endpoint

Change from baseline in 12-lead ECG (QRS interval)

Time frame:baseline (day 1), follow-up visit (day 8)

change from baseline, event

Secondary/protocol endpoint

Change from baseline in 12-lead ECG (QT interval)

Time frame:baseline (day 1), follow-up visit (day 8)

change from baseline, event

Secondary/protocol endpoint

Change from baseline in 12-lead ECG (QTc intervals [Fridericia])

Time frame:baseline (day 1), follow-up visit (day 8)

change from baseline, event

Secondary/protocol endpoint

Change from baseline in Physical examination

Time frame:baseline (day 1), follow-up visit (day 8)

change from baseline, event

Secondary/protocol endpoint

Incidence of injection site reactions

Time frame:After administration of the trial products (day 1) until completion of the post-treatment follow-up visit (day 8).

event count, event

Secondary/protocol endpoint

AUC0-15min,SD, area under the plasma concentration time curve

Time frame:0 to 15 minutes after single dose

concentration, descriptive

Secondary/protocol endpoint

t1/2,SD, terminal half-life

Time frame:Measured for 24 hours after administration of a single s.c. dose

concentration, descriptive

Secondary/protocol endpoint

Change from baseline in 12-lead ECG (overall evaluation)

Time frame:baseline (day 1), follow-up visit (day 8)

change from baseline, event

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Onset of appearance

Time frame:Measured for 24 hours after administration of a single s.c. dose

time to event, event

Other (unclassified)

9 endpoints
Secondary/protocol endpoint/low confidence

Change from baseline in haematology

Time frame:baseline (day 1), follow-up visit (day 8)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in biochemistry

Time frame:baseline (day 1), follow-up visit (day 8)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in fibrinogen

Time frame:baseline (day 1), follow-up visit (day 8)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in hormones

Time frame:baseline (day 1), follow-up visit (day 8)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in urine dipstick parameter

Time frame:baseline (day 1), follow-up visit (day 8)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in body temperature

Time frame:baseline (day 1), follow-up visit (day 8)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in respiration rate

Time frame:baseline (day 1), follow-up visit (day 8)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in prothrombin time

Time frame:baseline (day 1), follow-up visit (day 8)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in Activated Partial Thromboplastin time (APTT)

Time frame:baseline (day 1), follow-up visit (day 8)

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 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 November 5, 2026 snapshot.