GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Research Study Looking at a New Study Medicine (NNC0194-0499) for Weight Control in People With Overweight or Obesity

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

Lead sponsor

Novo Nordisk A/S

Asset

NNC0194-0499

Subcutaneous · FGF21 analog

Listed sites

Recruiting sites

—

Enrollment

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 IDNCT03479892

Org study IDNN9499-4287

Secondary IDU1111-1193-7228World Health Organization (WHO)

Timeline

Milestones

Study start2018-03-13actual

Study first posted2018-03-27actual

Primary completion2019-06-04actual

Study completion2019-06-04actual

Last update posted2019-06-26actual

Assets

Investigational agents

NNC0194-0499

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age22 Years

Maximum age55 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male aged 22-55 years (both inclusive) or female aged 22-45 years (both inclusive) at the time of signing informed consent

•Female must have regular menstrual cycle(defined as 24-35 days between 1st day of menses for two most recent menstrual periods, self-reported)

•Female must have bilateral tubal ligation or must be willing to use non-hormonal intrauterine device or diaphragm /cervical cap with spermicide in combination with condom for male partner(s)

•Body mass index (BMI) between 27.0 and 39.9 kg/sqm (both inclusive). Overweight should be due to excess adipose tissue, as judged by the investigator

•Considered by the investigator to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG, and clinical laboratory tests performed during the screening visit

Exclusion criteria

•Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol

•Use of prescription or non-prescription medicinal products including herbal products and non-routine vitamins, within 2 weeks prior to screening. Mild painkillers are allowed until 24 hours prior to screening

•History or presence of bone disease or otherwise increased risk of bone fracture as evaluated by dual-energy x-ray absorptiometry and as judged by the investigator

Endpoints (16)

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.

Coverage by outcome category

Safety / tolerability / PK

Cardiometabolic biomarkers

4 endpoints

Secondary/protocol endpoint

Change in heart rate

Time frame:Baseline (Day 1), Follow-up (Day 112)

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change in fibrinogen

Time frame:Baseline (Day -1), Follow-up (Day 112)

Fibrinogen, change

change from baseline, improvement

Secondary/protocol endpoint

Change in systolic blood pressure

Time frame:Baseline (Day 1), Follow-up (Day 112)

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in diastolic blood pressure

Time frame:Baseline (Day 1), Follow-up (Day 112)

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Safety / tolerability / PK

12 endpoints

Primary/protocol endpoint

Number of treatment emergent adverse events (TEAEs)

Time frame:From first administration of NNC0194-0499 (Day 1) to follow-up (Day 112)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Change in biochemistry

Time frame:Baseline (Day -1), Follow-up (Day 112)

change from baseline, descriptive

Secondary/protocol endpoint

Change in haematology

Time frame:Baseline (Day -1), Follow-up (Day 112)

change from baseline, descriptive

Secondary/protocol endpoint

Change in prothrombin time read as international normalised ratio (INR)

Time frame:Baseline (Day -1), Follow-up (Day 112)

change from baseline, descriptive

Secondary/protocol endpoint

Change in activated partial thromboplastin time (APTT)

Time frame:Baseline (Day -1), Follow-up (Day 112)

change from baseline, descriptive

Secondary/protocol endpoint

Changes in electrocardiogram (ECG)

Time frame:Baseline (Day 1), Follow-up (Day 112)

change from baseline, descriptive

Secondary/protocol endpoint

Number of injection site reactions

Time frame:From baseline (Day 1) to follow-up (Day 112)

event count, event

Secondary/protocol endpoint

Occurrence of anti-NNC0194-0499 antibodies

Time frame:From baseline (Day 1) to follow-up (Day 112)

Immunogenicity (ADA)

categorical status, event

Secondary/protocol endpoint

t½,SS: the terminal serum half-life of NNC0194-0499 at steady state

Time frame:From last dose (Day 78, pre-dose) until the follow-up (Day 112)

Half-life

descriptive

Secondary/protocol endpoint

Cmax,SS: the maximum concentration of NNC0194-0499 in serum at steady state

Time frame:From last dose (Day 78, pre-dose) until the follow-up (Day 112)

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax,SS: the time to maximum concentration of NNC0194-0499 in serum at steady state

Time frame:From last dose (Day 78, pre-dose) until the follow-up (Day 112)

Tmax

descriptive

Secondary/protocol endpoint

CL/F SS: the apparent total serum clearance of NNC0194-0499 at steady state

Time frame:From last dose (Day 78, pre-dose) until the follow-up (Day 112)

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.