GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

Investigate Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-0530 Alone and in Combination With Liraglutide in Overweight to Obese But Otherwise Healthy Male Subjects

A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-0530 Alone and in Combination With Liraglutide in Overweight to Obese But Otherwise Healthy Male Subjects.

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

163

actual

Study population

Obesity / overweight

Key I/E criteria

•BMI 27-35•Male•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 IDNCT02235961

Org study IDNN9030-4111

Secondary IDU1111-1151-0761WHO

Timeline

Milestones

Study start2014-09-04actual

Study first posted2014-09-10estimated

Primary completion2016-07-06actual

Study completion2016-07-06actual

Last update posted2017-07-27actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

•Male, age between (both inclusive) 18 and 55 years at the time of signing inform consent

•Overweight or obese but otherwise healthy male subjects; BMI of between or equal to 27.0 and 35.0 kg/m^2

Exclusion criteria

•Thyroid stimulating hormone values outside 0.4-6.0 mIU/l

•HbA1c (glycated hemoglobin) above or equal to 6.5%

•Any clinically relevant ECG (electrocardiogram) findings (e.g. 2nd or 3rd degree AV-block), in particular subjects with repeated demonstration of a QTcF (QT interval corrected by Fridericia formula) interval above 430 ms

•A history of additional risk factors for Torsades de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)

•The use of concomitant medications that prolong the QT/QTc interval

•Obesity caused by endocrinology disorders (e.g. Cushing's Syndrome)

•Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2

•Calcitonin above 50 ng/L

•History of pancreatitis (acute or chronic)

Endpoints (5)

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

5 endpoints

Primary/protocol endpoint

Number of treatment emergent adverse events recorded

Time frame:From time of dosing of NNC9204-0530 (Day 1) until completion of the follow-up visit (Day 21-27)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Area under the NNC9204-0530 serum concentration-time curve

Time frame:From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum concentration of NNC9204-0530 in serum

Time frame:From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points

Cmax

concentration, descriptive

Secondary/protocol endpoint

The time to maximum concentration of NNC9204-0530 in serum

Time frame:From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points

Tmax

concentration, descriptive

Secondary/protocol endpoint

The terminal half-life of NNC9204-0530

Time frame:From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points

Half-life

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.