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CompletedPhase 1

A Research Study Looking at Different Oral Formulations and the Effect of Food Intake on How the Medicine NNC0487-0111 Behaves in the Body of Participants Living With Overweight or Obesity

Investigating the Exposure of NNC0487-0111 in Different Oral Formulations and the Effect of Food Intake on Pharmacokinetics of NNC0487-0111 in Participants With Overweight or Obesity

Lead sponsor

Novo Nordisk A/S

Asset

Amycretin / zenagamtide

Oral · GLP-1 / amylin

Listed sites

1

Recruiting sites

Enrollment

133

actual

Study population

Obesity / overweight

Key I/E criterion

BMI 27-39.9

Primary endpoint

Plasma concentration (steady state)

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 IDNCT06478563
Org study IDNN9487-7980
Secondary IDU1111-1300-3720Universal Trial Number

Timeline

Milestones

Study first posted2024-06-27actual
Study start2024-06-27actual
Primary completion2025-06-05actual
Study completion2025-07-01actual
Last update posted2025-08-11actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age64 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Male or female
Age 18-64 years (both inclusive)
Body mass index (BMI) between 27.0 and 39.9 kilogram per meter square (kg/m^2) (both inclusive)
Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion criteria

Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:
Vitamin D (25-hydroxycholecalciferol) less than (<) 12 ng/mL (30 Nanometer (nM)) at screening
Parathyroid hormone (PTH) outside normal range at screening
Total calcium outside normal range at screening
Calcitonin greater than or equal to (≥) 50 pg/mL at screening
Amylase greater than or equal to (≥) 2 times upper limit of normal
Lipase greater than or equal to (≥) 2 times upper limit of normal
Glycated hemoglobin (HbA1c) greater than or equal to (≥) 6.5 % (48 millimoles per mole (mmol/mol)) at screening

Endpoints (8)

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

8 endpoints
Primary/protocol endpoint

Phase A: The area under the NNC0487-0111 plasma concentration-time curve during a dosing interval at steady state

Time frame:From pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Phase A: The maximum observed plasma concentration of NNC0487-0111 at steady state

Time frame:From pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Phase A: The time from dose administration to maximum observed plasma concentration of NNC0487-0111 at steady state

Time frame:From pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126

Tmax

concentration, descriptive

Secondary/protocol endpoint

Phase B: The area under the NNC0487-0111 plasma concentration-time curve

Time frame:From pre-dose to after dosing on day 132

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Phase B: The maximum plasma concentration of NNC0487-0111 after the last dose

Time frame:From pre-dose to after dosing on day 132

Cmax

concentration, descriptive

Secondary/protocol endpoint

Phase B: The time to maximum observed plasma concentration of NNC0487-0111 after the last dose

Time frame:From pre-dose to after dosing on day 132

Tmax

descriptive

Secondary/protocol endpoint

Phase B:The terminal half-life of NNC0487-0111 after the last dose

Time frame:From pre-dose on day 132 until completion of the end of study visit (day 153)

Half-life

descriptive

Secondary/protocol endpoint

Number of treatment emergent adverse events (TEAE)

Time frame:From time of trial product administration (Visit 2, day 1) until completion of the end of study visit (day 153)

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.