DelfaGLP-1 Atlas

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CompletedPhase 1

A Research Study on How NNC0487-0111 Works in People With Overweight or Obesity

Safety, Tolerability and 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

2

Recruiting sites

—

Enrollment

144

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI 25-34.9

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 IDNCT05369390
Org study IDNN9487-4830
Secondary IDU1111-1270-0852World Health Organization (WHO)

Timeline

Milestones

Study first posted2022-05-11actual
Study start2022-05-11actual
Primary completion2024-01-09actual
Study completion2024-01-09actual
Last update posted2025-06-15actual

Assets

Investigational agents

Amycretin / zenagamtide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

Part A and B:

•Male or female aged 18-55 years (both inclusive) at time of signing informed consent
•Body mass index (BMI) of 25.0 to 34.9 kilogram per square meter (kg/m^2) (both inclusive) at screening
•Considered eligible 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.

Part C and D:

•Male or female aged 18-55 years (both inclusive) at time of signing informed consent
•Body mass index (BMI) of 27.0 to 39.9 kg/m^2 (both inclusive) at screening
•Considered eligible 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

Part A and B:

•Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
•HbA1c greater than or equal to 6.5 % (48 millimoles per mole (mmol/mol)) at screening
•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 20 Nanograms per milliliter (ng/mL) (50 nano molar (NM)) at screening
•Parathyroid hormone (PTH) outside normal range at screening
•Total calcium outside normal range at screening
•Amylase greater than or equal to 2 times upper limit of normal at screening
•Lipase greater than or equal to 2 times upper limit of normal at screening

Part C and D:

•Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
•HbA1c greater than or equal to 6.5 % (48 mmol/mol) at screening
•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 20 ng/mL (50 nM) at screening
•Parathyroid hormone (PTH) outside normal range at screening
•Total calcium outside normal range at screening
•Amylase greater than or equal to 2 times upper limit of normal at screening
•Lipase greater than or equal to 2 times upper limit of normal at screening

Endpoints (7)

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

7 endpoints
Primary/protocol endpoint

Number of treatment emergent adverse events (TEAE)

Time frame:Part A: From pre-dose on Day 1 to 22 days; Part B: From pre-dose on Day 1 to 31 days; Part C and D: From pre-dose on Day 1 to 105 days

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Part A: AUC0-∞,SD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose

Time frame:From pre-dose on Day 1 until completion of the end of study visit (Day 22)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Part A: Cmax,SD; the maximum plasma concentration of NNC0487- 0111 after a single dose

Time frame:From pre-dose on Day 1 until completion of the end of study visit (Day 22)

Cmax

concentration, descriptive

Secondary/protocol endpoint

Part B: AUC0-24h,MD; the area under the NNC0487-011 plasma concentration-time curve from time 0 to 24 hours after last multiple dose

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

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:From pre-dose on Day 10 until Day 22

Cmax

concentration, descriptive

Secondary/protocol endpoint

Part C and D: AUC0-24h,MD; the area under the NNC0487-011 plasma concentration-time curve from time 0 to 24 hours after last multiple dose

Time frame:From pre-dose on Day 84 until Day 85 (24 hours post-dose)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Part C and D: Cmax,MD; the maximum plasma concentration of NNC0487- 0111 after last multiple dose

Time frame:From pre-dose on Day 84 until completion of the end of study visit (Day 105)

Cmax

concentration, 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.