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CompletedPhase 1

A Research Study of NNC0165-1875 Alone or Together With Semaglutide in People Who Are Overweight or Obese

A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of Single Doses of NNC0165-1875 as Monotherapy and in Combination With Semaglutide in Subjects With Overweight or Obesity

Lead sponsor

Novo Nordisk A/S

Assets

NNC0165-1875 / Semaglutide

Listed sites

1

Recruiting sites

Enrollment

88

actual

Study population

Obesity / overweight

Key I/E criteria

BMI 25-34.9Male

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 IDNCT03707990
Org study IDNN9775-4398
Secondary IDU1111-1212-3615World Health Organization (WHO)

Timeline

Milestones

Study start2018-10-15actual
Study first posted2018-10-16actual
Primary completion2019-08-13actual
Study completion2019-08-13actual
Last update posted2019-09-06actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

SexMale
Healthy volunteersAccepted

Inclusion criteria

Males, aged 18-55 years (both inclusive) at the time of signing informed consent
Body mass index (BMI) between 25.0 and 34.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator
Body weight greater than or equal to 70 kg

Exclusion criteria

- Male of reproductive age who or whose partner(s) is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)

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:Day 1-36

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

AUC0-∞,1875,SD; the area under the NNC0165-1875 plasma concentration-time curve from time 0 to infinity after a single s.c. dose

Time frame:1-36 days

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,1875,SD; the maximum plasma concentration of NNC0165-1875 after a single s.c. dose

Time frame:1-36 days

Cmax

concentration, descriptive

Secondary/protocol endpoint

AUC0-∞,sema,SD; the area under the semaglutide plasma concentration-time curve from time 0 to infinity after a single s.c. dose

Time frame:1-36 days

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,sema,SD; the maximum plasma concentration of semaglutide after a single s.c. dose

Time frame:1-36 days

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.