DelfaGLP-1 Atlas

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CompletedPhase 1

First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Male Subjects With Overweight or Obesity

A Randomised, Double-blinded, Single-dose, Dose-escalation, First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Male Subjects With Overweight or Obesity

Lead sponsor

Novo Nordisk A/S

Asset

NNC0194-0499

Subcutaneous · FGF21 analog

Listed sites

1

Recruiting sites

—

Enrollment

56

actual

Study population

Obesity / overweight

Key I/E criteria

•BMI 25-34.9•Male

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 IDNCT03015207
Org study IDNN9499-4277
Secondary IDU1111-1181-9045WHO

Timeline

Milestones

Study start2017-01-06actual
Study first posted2017-01-09estimated
Primary completion2017-10-26actual
Study completion2017-10-26actual
Last update posted2018-09-05actual

Assets

Investigational agents

NNC0194-0499

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age22 Years
Maximum age55 Years
SexMale
Healthy volunteersNot accepted

Inclusion criteria

•Male, aged 22-55 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). Overweight should be due to excess adipose tissue, as judged by the investigator

Exclusion criteria

•Any concomitant illness or disorder, which in the investigator's opinion might jeopardise the subject's safety or compliance with the protocol
•Subjects aged above or equal to 40 years with an estimated 10-year atherosclerotic cardiovascular disease (ASCVD according to ACC/AHA (American College of Cardiology /American Heart Association) guideline) risk above or equal to 5%
•Male subjects who are not sexually abstinent or surgically sterilised (vasectomy) and are sexually active with female partner(s) and who are 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 (visit 1) until 3 months following administration of the investigational medical product
•Use of prescription or non-prescription medicinal products including herbal products and non-routine vitamins, within 2 weeks prior to screening, with the exception of occasional use of acetaminophen, ibuprofen or acetylsalicylic acid

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 administration of NNC0194-0499 (day 1) to completion of the post-treatment period at follow-up (day 36)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

The area under the NNC0194-0499 serum concentration-time curve after a single subcutaneous administration

Time frame:From pre-dose (day 1) until the followup (day 36)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

The maximum concentration of NNC0194-0499 in serum after a single subcutaneous administration

Time frame:From pre-dose (day 1) until the followup (day 36)

Cmax

concentration, descriptive

Secondary/protocol endpoint

The time to maximum concentration of NNC0194-0499 in serum after a single subcutaneous administration

Time frame:From pre-dose (day 1) until the followup (day 36)

Tmax

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.

Registry references + supporting bibliography

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.