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CompletedPhase 1

A Research Study of How NNC0174-0833 Behaves in Japanese and Caucasian Volunteers Who Are Normal Weight, Overweight or With Obesity

Investigation of Pharmacokinetic Properties, Safety and Tolerability of Single Subcutaneous Doses of NNC0174-0833 in Male Japanese and Caucasian Subjects Being Normal Weight, Overweight or With Obesity

Lead sponsor

Novo Nordisk A/S

Asset

CagriSema / cagrilintide

Subcutaneous · GLP-1 / amylin

Listed sites

1

Recruiting sites

Enrollment

66

actual

Study population

Healthy volunteers, Obesity / overweight

Key I/E criteria

BMI 20-39.9Male

Primary endpoint

AUC0-∞,AM833

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 IDNCT03787225
Org study IDNN9838-4483
Secondary IDU1111-1219-7303World Health Organization (WHO)

Timeline

Milestones

Study first posted2018-12-26actual
Study start2019-01-07actual
Primary completion2019-06-04actual
Study completion2019-06-04actual
Last update posted2019-06-24actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

SexMale
Healthy volunteersNot accepted

Inclusion criteria

Male, aged 18-55 years (both inclusive) at the time of signing informed consent.
For Japanese subjects, both parents of Japanese descent and both paternal and maternal grandparents of Japanese descent.
For Caucasian subjects, self-reported European descent or white Latin-American descent.
Body mass index (BMI) between 20.0 and 39.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
Body weight between 60 and 110 kg (both inclusive) at screening

Exclusion criteria

Male subject who is not surgically sterilised (vasectomy) and is sexually active (with female partner[s] of childbearing potential), who is not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their non-pregnant female partner(s) (Pearl Index less than 1%), or intend to donate sperm in the period from screening until 3 months following administration of the investigational medical product.
Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.

Endpoints (3)

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

3 endpoints
Primary/protocol endpoint

AUC0-∞,AM833: the area under the NNC0174-0833 plasma concentration-time curve from time 0 to infinity after single dose

Time frame:From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,AM833: the maximum concentration of NNC0174-0833 in plasma

Time frame:From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)

Cmax

concentration, descriptive

Secondary/protocol endpoint

Number of treatment emergent adverse events (TEAEs)

Time frame:From time of first dosing (Day 1) until completion of the post-treatment follow-up visit (Day 36)

Treatment-emergent AEs (any)

event count, event

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.