CompletedPhase 1

Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dosing of NNC0174-0833 in Subjects With Obesity or Overweight

Lead sponsor

Novo Nordisk A/S

Asset

CagriSema / cagrilintide

Subcutaneous · GLP-1 / amylin

Listed sites

Recruiting sites

Actual enrollment

Study population

Obesity / overweight

Eligibility highlights

•BMI 25-39.9

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 IDNCT02958085

Org study IDNN9838-4021

Secondary IDU1111-1131-7209WHO

Timeline

Milestones

Study start2016-11-04actual

Study first posted2016-11-08estimated

Primary completion2018-01-24actual

Study completion2018-01-24actual

Last update posted2018-02-01actual

Assets

Investigational agents

CagriSema / cagrilintide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age22 Years

Maximum age55 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female of non-childbearing potential (NCBP), aged 22-55 years (both inclusive) at the time of signing informed consent

•Body mass index (BMI) between 25.0 and 39.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess of adipose tissue, as judged by the investigator

Exclusion criteria

•History or presence of any clinically relevant respiratory, metabolic, renal, hepatic,gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or other major disorders including sleep apnoea or excessive sleepiness that might require medical attention

•History or presence of cardiovascular disease including stable and unstable angina, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, and heart failure

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

•Male subject who is not surgically sterilised (vasectomy) and is sexually active with female partner(s) and 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) of childbearing potential (Pearl Index below 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide), and/or intend to donate sperm in the period from screening until 3 months following administration of the last dose of investigational medical 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 time of first dosing (Day 1) to the post-treatment follow-up visit (Day 99)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

The area under the NNC0174-0833 plasma concentration-time curve

Time frame:From time 0 to 24 hours at steady state

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

The area under the NNC0174-0833 plasma concentration-time curve

Time frame:From time 0 to 168 hours at steady state

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

The maximum concentration of NNC0174-0833 in plasma at steady state

Time frame:Day 1; Day 57

Plasma concentration (steady state)

concentration, 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.