GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A First-in-human Study Looking at the Safety of ZP8396 and How it Works in the Body of Healthy Trial Participants

A First-in-human, Randomised, Single Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZP8396 Administered to Healthy Subjects

Lead sponsor

Zealand Pharma

Asset

Petrelintide

Subcutaneous · Amylin analog

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 21-29.9•HbA1c ≤5.7%•Male•Healthy volunteers

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 IDNCT05096598

Org study IDZP8396-21037

Secondary ID2021-001712-28

Secondary IDU1111-1267-1489WHO

Timeline

Milestones

Study start2021-10-19actual

Study first posted2021-10-27actual

Primary completion2023-01-12actual

Study completion2023-01-12actual

Last update posted2023-01-17actual

Assets

Investigational agents

Petrelintide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

•Healthy male subject

•Body Mass Index (BMI) between 21.0 and 29.9 kg/m^2, both inclusive

•Body weight of at least 70.0 kg

•Glycosylated hemoglobin A1c (HbA1c) less than 5.7 percent

•Further inclusion criteria apply

Exclusion criteria

•History of metabolic diseases more frequently associated with obesity, e.g. type-2-diabetes mellitus, hypertension, dyslipidemia, heart disease or stroke

•Systolic blood pressure < 90 mmHg or >139 mmHg and/or diastolic blood pressure less than 50 mmHg or greater than 89 mmHg

•Symptoms of arterial hypotension

•Further exclusion criteria apply

Endpoints (29)

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

Glycemic / diabetes

Other (unclassified)

Glycemic / diabetes

7 endpoints

Secondary/protocol endpoint

Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax, Plasma Glucose [PG])

Time frame:0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5

concentration, descriptive

Secondary/protocol endpoint

Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax, Plasma Glucose [PG])

Time frame:0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5

descriptive

Secondary/protocol endpoint

Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCPG,0-60 min)

Time frame:0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5

Postprandial glucose

concentration, descriptive

Secondary/protocol endpoint

Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCPG,0-240 min)

Time frame:0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5

Postprandial glucose

concentration, descriptive

Secondary/protocol endpoint

Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCinsulin,0-60 min)

Time frame:0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5

concentration, descriptive

Secondary/protocol endpoint/low confidence

Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCinsulin,0-240 min)

Time frame:0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5

C-peptide AUC

concentration, descriptive

Secondary/protocol endpoint/low confidence

Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCglucagon,0-60 min)

Time frame:0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5

concentration, descriptive

Safety / tolerability / PK

21 endpoints

Primary/protocol endpoint

Incidence of treatment emergent adverse events (TEAEs)

Time frame:From dosing (Day 1) to end of trial (Day 50)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Pharmacokinetics (PK) of ZP8396 (AUCτ)

Time frame:Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK) of ZP8396 (AUCinf)

Time frame:Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK) of ZP8396 (AUClast)

Time frame:Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK) of ZP8396 (Cmax)

Time frame:Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

Cmax

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK) of ZP8396 (tmax)

Time frame:Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

Tmax

descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK) of ZP8396 (λz)

Time frame:Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK) of ZP8396 (t½)

Time frame:Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

Half-life

descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK) of ZP8396 (Vz/f)

Time frame:Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK) of ZP8396 (Vz)

Time frame:Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK) of ZP8396 (CL/f)

Time frame:Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK) of ZP8396 (CL)

Time frame:Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK) of ZP8396 (MRT)

Time frame:Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

descriptive

Secondary/protocol endpoint

Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax acetaminophen)

Time frame:0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5

Cmax

concentration, descriptive

Secondary/protocol endpoint

Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax acetaminophen)

Time frame:0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5

Tmax

descriptive

Secondary/protocol endpoint

Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCacetaminophen, 0-60 min)

Time frame:0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCacetaminophen, 0-240 min)

Time frame:0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax, insulin)

Time frame:0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5

concentration, descriptive

Secondary/protocol endpoint

Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax, insulin)

Time frame:0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5

Tmax

descriptive

Secondary/protocol endpoint

Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax, glucagon)

Time frame:0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5

concentration, descriptive

Secondary/protocol endpoint

Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax, glucagon)

Time frame:0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5

Tmax

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCglucagon,0-240 min)

Time frame:0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5

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.