GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Research Study Comparing Blood Levels of Medicines NNC0194-0499 and Semaglutide Administered as a Combination Formulation Versus Two Separate Formulations

Investigation of Pharmacokinetics Following Administration of NNC0194-0499 and Semaglutide as Co-formulation Versus Separate Injections in Healthy Participants

Lead sponsor

Novo Nordisk A/S

Assets

NNC0194-0499 / Semaglutide

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers, Obesity / overweight

Key I/E criteria

•BMI ≥25•Healthy volunteers

Primary endpoints

•AUC 0-168 hour (h), 0499, steady state (SS)•AUC 0-168h,sema,SS•Cmax, 0499, SS

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 IDNCT05766709

Org study IDNN9500-4932

Secondary IDU1111-1285-5065World Health Organization (WHO)

Timeline

Milestones

Study start2023-03-02actual

Study first posted2023-03-13actual

Primary completion2024-01-05actual

Study completion2024-02-09actual

Last update posted2024-02-29actual

Assets

Investigational agents

NNC0194-0499 Semaglutide

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Male or female

•Aged 18-55 years (both inclusive) at the time of signing informed consent

•Body mass index (BMI) between greater than or equal to 25 and less than or equal to 35 kilogram per meter square (kg/m^2) (both inclusive)

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

Exclusion criteria

•Known or suspected hypersensitivity to study intervention(s) or related products

•Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method

•Participation (that is, signed informed consent) in any other interventional clinical study within 90 days before first trial product administration (Visit 2, Day 1)

•Use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medication, highly effective contraceptives and occasional use of paracetamol, acetylsalicylic acid within 14 days before first trial product administration (Visit 2, Day 1)

Endpoints (9)

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

9 endpoints

Primary/protocol endpoint

AUC 0-168 hour (h), 0499, steady state (SS): Area under the NNC0194-0499 concentration time curve during a dosing interval (0-168 hours) at steady state after dosing of NNC0194-0499 in combination with semaglutide

Time frame:Day 134 (pre-dose) to Day 141 (168 hours post-dose)

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

AUC 0-168h,sema,SS: Area under the semaglutide concentration time curve during a dosing interval (0-168 hours) at steady state after dosing of NNC0194-0499 in combination with semaglutide

Time frame:Day 134 (pre-dose) to Day 141 (168 hours post-dose)

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Cmax, 0499, SS: Maximum concentration of NNC0194-0499 at steady state after dosing of NNC0194-0499 in combination with semaglutide

Time frame:Day 134 (pre-dose) to Day 141 (168 hours post-dose)

Cmax

concentration, descriptive

Primary/protocol endpoint

Cmax,sema, SS: Maximum concentration of semaglutide at steady state after dosing of NNC0194-0499 in combination with semaglutide

Time frame:Day 134 (pre-dose) to Day 141 (168 hours post-dose)

Cmax

concentration, descriptive

Secondary/protocol endpoint

AUC 0-168h, 0499, SS: Area under the NNC0194-0499 concentration-time curve during a dosing interval (0-168 hours) at steady state after dosing of NNC0194-0499 in combination with semaglutide

Time frame:Day 22 (pre-dose) to Day 29 (168 hours post-dose)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

AUC 0-168h, sema , SS: Area under the semaglutide concentration-time curve during a dosing interval (0-168 hours) at steady state after dosing of semaglutide in combination with NNC0194-0499

Time frame:Day 22 (pre-dose) to Day 29 (168 hours post-dose)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax, 0499, SS: Maximum concentration of NNC0194-0499 at steady state after dosing of NNC0194-0499 in combination with semaglutide

Time frame:Day 22 (pre-dose) to Day 29 (168 hours post-dose)

Cmax

concentration, descriptive

Secondary/protocol endpoint

Cmax, sema , SS: Maximum concentration of semaglutide at steady state after dosing of semaglutide in combination with NNC0194-0499

Time frame:Day 22 (pre-dose) to Day 29 (168 hours post-dose)

Cmax

concentration, descriptive

Secondary/protocol endpoint

Number of treatment emergent adverse events

Time frame:Day 1 (post-dose) to Day 197 (Groups 1 and 2) and Day 1 (post-dose) to Day 57 (Group 3)

Treatment-emergent AEs (any)

event count, event

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.