GLP-1 Peptide Atlas, by Delfa

Active not recruitingPhase 1

A Research Study on How NNC0638-0355, a New Medicine, Works in People Living With Overweight or Obesity

A Randomised, Placebo Controlled, Double Blinded Study Assessing the Safety, Tolerability and Pharmacokinetics of Single and Multiple Subcutaneous Doses of NNC0638-0355 in Participants With Overweight or Obesity

Lead sponsor

Novo Nordisk A/S

Asset

NNC0638-0355

Subcutaneous · Amylin analog

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI 25-34.9

Primary endpoints

•Part•Part B,C,D and E

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 IDNCT06577766

Org study IDNN9638-7569

Secondary IDU1111-1296-8015World Health Organization (WHO)

Timeline

Milestones

Study first posted2024-08-29actual

Study start2024-09-03actual

Last update posted2026-03-17actual

Primary completion2026-09-24estimated

Study completion2026-09-24estimated

Assets

Investigational agents

NNC0638-0355

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersNot accepted

Eligibility criteria

Key inclusion criteria

•Male or female.

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

•BMI between 25.0 and 34.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.

•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.

Key exclusion criteria

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

•Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

•HbA1c greater than or equal to 6.5 percentage (48 mmol/mol) at screening.

•Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:

1. Vitamin D (25-hydroxycholecalciferol) less than 12 ng/mL (30 nM) at screening

2. Parathyroid hormone (PTH) outside normal range at screening

3. Total calcium outside normal range at screening

Endpoints (6)

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

6 endpoints

Primary/protocol endpoint

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

Time frame:From NNC0638-0355 administration (day 1) to completion of the end of study visit (6 weeks)

event count, event

Primary/protocol endpoint

Part B,C,D and E : Number of treatment emergent adverse events (TEAE)

Time frame:From first NNC0638-0355 administration (day 1) to completion of the end of study visit (20 weeks)

event count, event

Secondary/protocol endpoint

Part A: AUC; area under the NNC0638-0355 plasma concentration-time curve

Time frame:From NNC0638-0355 administration (day 1) to completionof the end of study visit (6 weeks)

concentration, descriptive

Secondary/protocol endpoint

Part A: Cmax; maximum observed NNC0638-0355 plasma concentration

Time frame:From NNC0638-0355 administration (day 1) to completionof the end of study visit (6 weeks)

concentration, descriptive

Secondary/protocol endpoint

Part B,C,D and E: AUC; area under the NNC0638-0355 plasma concentration-time curve

Time frame:From first NNC0638-0355 administration (day 1) to completionof the end of study visit (20 weeks)

concentration, descriptive

Secondary/protocol endpoint

Part B,C,D and E: Cmax; maximum observed NNC0638-0355 plasma concentration

Time frame:From first NNC0638-0355 administration (day 1) to completionof the end of study visit (20 weeks)

concentration, 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.