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CompletedPhase 1

A Research Study of How a New Medicine Called Amycretin, Given as Tablets, Works in Japanese Men With Obesity

Investigation of Safety, Tolerability and Pharmacokinetic Properties of Multiple Doses of Oral NNC0487-0111 in Japanese Participants With Obesity

Lead sponsor

Novo Nordisk A/S

Asset

Amycretin / zenagamtide

Oral · GLP-1 / amylin

Listed sites

1

Recruiting sites

Enrollment

36

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 IDNCT06049329
Org study IDNN9487-5022
Secondary IDU1111-1284-5901World Health Organization (WHO)

Timeline

Milestones

Study start2023-09-14actual
Study first posted2023-09-22actual
Primary completion2023-12-15actual
Study completion2023-12-15actual
Last update posted2025-03-05actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexMale
Healthy volunteersNot accepted

Eligibility criteria

Key inclusion criteria

Male with both parents of Japanese descent
Body mass index (BMI) between 25.0 and 34.9 kg/m^2 (both inclusive). Body weight equal to or greater than 65.0 kg
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

Key exclusion criteria

Any disorder that in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, or as judged by the investigator

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 (TEAE)

Time frame:From pre-dose on Day 1 until completion of the end of study visit Day 31

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

AUC,MD; the area under the NNC0487-0111 plasma concentration-time curve after last multile dose

Time frame:From pre-dose on Day 10 until Day 11 (24 hours post-dose)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,MD; the maximum plasma concentration of NNC0487-0111 after last multiple dose

Time frame:From pre-dose on Day 10 until completion of the end of study visit Day 31

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax,MD; the time of maximum plasma concentration of NNC0487-0111 after last multiple dose

Time frame:From pre-dose on Day 10 until completion of the end of study visit Day 31

Tmax

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.