CompletedPhase 1

Investigation on Safety, Tolerability and Pharmacokinetics of Single Doses of NNC0174-0833 in Normal Weight, Overweight to Obese But Otherwise Healthy Male Subjects

Lead sponsor

Novo Nordisk A/S

Asset

CagriSema / cagrilintide

Subcutaneous · GLP-1 / amylin

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers, Obesity / overweight

Eligibility highlights

•BMI 20-35•Male•Healthy volunteers

Primary endpoint

•Treatment-emergent AEs (any)

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 IDNCT02300844

Org study IDNN9838-3993

Secondary IDU1111-1131-7160WHO

Timeline

Milestones

Study first posted2014-11-25estimated

Study start2014-12-01actual

Primary completion2016-03-21actual

Study completion2016-03-21actual

Last update posted2018-01-24actual

Assets

Investigational agents

CagriSema / cagrilintide

Who this study enrolls

Healthy volunteersObesity / overweight

Who can enroll

Minimum age22 Years

Maximum age64 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

•Normal weight, Overweight or obese (Body Mass Index [BMI]) between or equal to 20.0 and 35.0 kg/m^2 but otherwise healthy men

•Age between or equal to 22 and 64 years at the time of signing informed consent

Exclusion criteria

•History of, or presence of, cancer, diabetes or any clinically significant cardiovascular,respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders including sleep apnoea, as judged by the investigator

•Subjects with history of, or presence of, a disease being associated with impaired calcium homeostasis and/or increased bone turnover (e.g. Paget´s disease, osteoporosis)

•Male subjects of reproductive age who are not using a highly effective physical barrier method of contraception (sexual abstinence, or condom with spermicidal foam/gel/film/cream) combined with a method with Pearl Index less than 1% for their nonpregnant partner(s) (such as implants, injectables, combined oral contraceptives, hormonal intrauterine devices or diaphragm+spermicide, or surgical sterilisation or post-menopausal) and/or who intend to donate sperm in the period from start of Visit 2 up to 3 months following the administration of the investigational medicinal product

Endpoints (4)

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

4 endpoints

Primary/protocol endpoint

Number of treatment emergent adverse events (TEAEs)

Time frame:From the time of dosing (Day 1) until completion of the post treatment follow-up visit (Day 43-50)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Area under the NNC0174-0833 plasma concentration-time curve

Time frame:Prior to the initial dose on day 1 and 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 48, 60, 72, 96, 120, 168, 240, 336, 504, and 1008 hours post-dose

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

Maximum concentration of NNC0174-0833 in plasma

Time frame:Prior to the initial dose on day 1 and 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 48, 60, 72, 96, 120, 168, 240, 336, 504, and 1008 hours post-dose

Cmax

concentration, descriptive

Secondary/protocol endpoint

Time to maximum concentration of NNC0174-0833 in plasma

Time frame:Prior to the initial dose on day 1 and 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 48, 60, 72, 96, 120, 168, 240, 336, 504, and 1008 hours post-dose

Tmax

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.