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CompletedPhase 1

A Research Study of How NNC0174-0833 Taken With Semaglutide Works in People Who Are Overweight or Obese

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

Lead sponsor

Novo Nordisk A/S

Assets

CagriSema / cagrilintide / Semaglutide

Listed sites

1

Recruiting sites

Enrollment

96

actual

Study population

Obesity / overweight

Key I/E criterion

BMI 27-39.9

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 IDNCT03600480
Org study IDNN9838-4395
Secondary IDU1111-1203-6796World Health Organization (WHO)

Timeline

Milestones

Study start2018-07-25actual
Study first posted2018-07-26actual
Primary completion2020-06-12actual
Study completion2020-06-12actual
Last update posted2021-11-17actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Male or female of non-childbearing potential, aged 18-55 years (both inclusive) at the time of signing informed consent.
Body mass index (BMI) between 27.0 and 39.9 kg/sqm (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.

Exclusion criteria

Any disorder at screening which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
Male subject who is not sexually abstinent or surgically sterilised (vasectomy) and is sexually active with female partner(s) of childbearing potential 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) (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 (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 first administration of NNC0174-0833 (Day 1) to completion of the post-treatment follow-up (Day 176)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

AUC0-168h,AM833,SS: the area under the NNC0174-0833 plasma concentration-time curve from 0 to 168 hours at steady state

Time frame:From last dose (Day 134) until end of treatment (Day 141)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,AM833,SS: the maximum concentration of NNC0174-0833 in plasma at steady state

Time frame:From last dose (Day 134) until end of treatment (Day 141)

Cmax

concentration, descriptive

Secondary/protocol endpoint

AUC0-168h,sema,SS: the area under the semaglutide plasma concentration-time curve from 0 to 168 hours at steady state

Time frame:From last dose (Day 134) until end of treatment (Day 141)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,sema,SS: the maximum concentration of semaglutide in plasma at steady state

Time frame:From last dose (Day 134) until end of treatment (Day 141)

Cmax

concentration, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

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.