GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

First Research Study of the Possible New Medicine NNC0113-2023 in Healthy Men.

A First Human Dose Trial Investigating the Safety, Tolerability and Pharmacokinetics of Single Doses of Oral NNC0113-2023 in Healthy Male Subjects

Lead sponsor

Novo Nordisk A/S

Asset

CagriSema / cagrilintide

Subcutaneous · GLP-1 / amylin

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 20-29.9•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 IDNCT03617081

Org study IDNN9023-4408

Secondary IDU1111-1209-3837World Health Organization (WHO)

Timeline

Milestones

Study first posted2018-08-06actual

Study start2018-08-09actual

Primary completion2018-12-13actual

Study completion2018-12-13actual

Last update posted2020-01-10actual

Assets

Investigational agents

CagriSema / cagrilintide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age45 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

•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.

Exclusion criteria

•HbA1c greater than or equal to 6.5 % (48 mmol/mol) at screening.

•Use of tobacco and nicotine products, defined as any of the below: 1) Smoking more than 1 cigarettes or the equivalent per day or 2) Not willing to refrain from smoking and use of nicotine substitute products during the in-house period.

•History of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).

•Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.

•Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.

•Presence or 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 (TEAEs)

Time frame:From time of dosing (day 1) until completion of the follow-up visit (day 43)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

AUC0-∞,2023,SD; the area under the NNC0113-2023 plasma concentration-time curve from time 0 to infinity after a single dose of oral NNC0113-2023

Time frame:From baseline (day 1) to post treatment follow-up (day 43)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,2023,SD; the maximum plasma concentration of NNC0113-2023 after a single dose of oral NNC0113-2023

Time frame:From baseline (day 1) to post treatment follow-up (day 43)

Cmax

concentration, descriptive

Secondary/protocol endpoint

AUC0-24h,SNAC,SD; the area under the SNAC plasma concentration-time curve from time 0 to 24 hours after a single dose of oral NNC0113-2023

Time frame:From baseline (day 1) to 24 hours after dosing

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,SNAC,SD; the maximum plasma concentration of SNAC in plasma after a single dose of oral NNC0113-2023

Time frame:From baseline (day 1) to 24 hours after dosing

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.