DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT06064006

CompletedPhase 2

A Research Study to See How a New Medicine (NNC0487-0111) Works in People With Overweight or Obesity When Injected Under the Skin

A Randomised, Placebo-controlled and Double-blinded Study Assessing the Safety, Tolerability, Pharmacokinetics, and Efficacy of Subcutaneous Administrations 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

125

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 IDNCT06064006
Org study IDNN9490-7613
Secondary IDU1111-1289-3282World Health Organization (WHO)

Timeline

Milestones

Study start2023-09-15actual
Study first posted2023-10-03actual
Primary completion2024-11-27actual
Study completion2024-11-27actual
Last update posted2025-11-19actual

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 volunteersNot accepted

Inclusion criteria

•Male or female
•Aged 18-55 years (both inclusive) at the time of signing informed consent.
•Body Mass Index (BMI) between 27.0 and 39.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
•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

•Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
•HbA1c equal to or greater than 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) below 12 ng/mL (30 nM) at screening
–Parathyroid hormone (PTH) outside normal range at screening
–Total calcium outside normal range at screening
–Amylase equal to or greater than 2 times upper limit of normal at screening
–Lipase equal to or greater than 2 times upper limit of normal at screening
–Calcitonin equal to or greater than 50 ng/L 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.

Coverage by outcome category

Safety / tolerability / PK
6
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

PART B to E: Relative change in body weight

Time frame:From pre-dose on Day 1 until end of treatment (V34) up to Day 255

Body weight, % change

percent change from baseline, improvement

Safety / tolerability / PK

6 endpoints
Primary/protocol endpoint

PART A: Number of treatment emergent adverse events (TEAE)

Time frame:From pre-dose on Day 1 until completion of the end of study visit, up to Day 25

Treatment-emergent AEs (any)

event count, event

Primary/protocol endpoint

PARTS B to E: Number of treatment emergent adverse events (TEAE)

Time frame:From pre-dose on Day 1 until completion of the end of study visit (V37) up to Day 270

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, up to Day 25

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

PART A: Cmax,SD; the maximum plasma concentration of NNC0487-0111 after a single dose and the corresponding time tmax

Time frame:From pre-dose on Day 1 until completion of the end of study visit, up to Day 25

Cmax

concentration, descriptive

Secondary/protocol endpoint

PARTS B to E: AUC0-168h,SS; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to 168 hours after last multiple dose

Time frame:From pre-dose on V33D1 until end of treatment (V34) up to 9 days

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

PARTS B to E: Cmax,SS; the maximum plasma concentration of NNC0487-0111 after last multiple dose and the corresponding time tmax

Time frame:From pre-dose on V33D1 until end of study visit (V37) up to 24 days

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.