DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT05613387

CompletedPhase 1

A Research Study Looking at the Safety of Multiple Doses of ZP8396 and How it Works in the Body of Healthy Participants

A Randomized, Multiple 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

1

Recruiting sites

—

Enrollment

68

actual

Study population

Healthy volunteers, Obesity / overweight

Key I/E criteria

•BMI 21-29.9•HbA1c ≤5.7%

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 IDNCT05613387
Org study IDZP8396-21038

Timeline

Milestones

Study start2022-11-07actual
Study first posted2022-11-14actual
Primary completion2024-06-13actual
Study completion2024-06-13actual
Last update posted2024-06-18actual

Assets

Investigational agents

Petrelintide

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age64 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

Part 1:

•Body Mass Index (BMI) between 21.0 and 29.9 kg/m^2, both inclusive
•Glycosylated hemoglobin (HbA1c) below 5.7 percent

Further inclusion criteria apply

Part 2:

•Body Mass Index (BMI) between 27.0 and 39.9 kg/m^2, both inclusive
•Glycosylated hemoglobin (HbA1c) below 6.5 percent

Further inclusion criteria apply

Exclusion criteria

Part 1:

•History of metabolic diseases more frequently associated with obesity, e.g. type-2-diabetes mellitus, hypertension, dyslipidemia, heart disease or stroke
•Systolic blood pressure below 90 mmHg or above 139 mmHg and/or diastolic blood pressure below 50 mmHg or above 89 mmHg
•Symptoms of arterial hypotension

Further exclusion criteria apply

Part 2:

•History of metabolic diseases more frequently associated with obesity, e.g. type-2-diabetes mellitus, hypertension, dyslipidemia, heart disease or stroke
•Systolic blood pressure below 90 mmHg or above 159 mmHg and/or diastolic blood pressure below 50 mmHg or above 99 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
19
Glycemic / diabetes
6
Other (unclassified)
4

Glycemic / diabetes

6 endpoints
Secondary/protocol endpoint

Pharmacodynamics (PD) of ZP8396 (Emax, Plasma Glucose [PG])

Time frame:Part 1: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40; Part 2: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1, Day 110 for cohort 1 and 2, Day -1, Day 1, Day 107 for cohort 3

Postprandial glucose

concentration, descriptive

Secondary/protocol endpoint

Pharmacodynamics (PD) of ZP8396 (Tmax, Plasma Glucose [PG])

Time frame:Part 1: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40; Part 2: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1, Day 110 for cohort 1 and 2, Day -1, Day 1, Day 107 for cohort 3

descriptive

Secondary/protocol endpoint

Pharmacodynamics (PD) of ZP8396 (Emax, insulin)

Time frame:Part 1: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40

concentration, descriptive

Secondary/protocol endpoint

Pharmacodynamics (PD) of ZP8396 (AUEinsulin,0-60 minutes)

Time frame:Part 1: 0-60 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40

concentration, descriptive

Secondary/protocol endpoint

Pharmacodynamics (PD) of ZP8396 (AUEinsulin,0-240 min)

Time frame:Part 1: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40

concentration, descriptive

Secondary/protocol endpoint

Pharmacodynamics (PD) of ZP8396 (AUEglucagon,0-60 minutes)

Time frame:Part 1: 0-60 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40

concentration, descriptive

Safety / tolerability / PK

19 endpoints
Primary/protocol endpoint

Incidence of treatment emergent adverse events (TEAEs)

Time frame:Part 1: From dosing (Day 1) to end of trial (Day 92); Part 2: From dosing (Day 1) to end of trial (Day 169 for Cohort 1 and 2, Day 176 for Cohort 3)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Pharmacokinetics (PK) of ZP8396 (AUCτ)

Time frame:Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK) of ZP8396 (AUCinf)

Time frame:Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK) of ZP8396 (AUClast)

Time frame:Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK) of ZP8396 (Cmax)

Time frame:Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3

Cmax

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK) of ZP8396 (tmax)

Time frame:Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3

Tmax

descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK) of ZP8396 (λz)

Time frame:Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3

descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK) of ZP8396 (t½)

Time frame:Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3

Half-life

descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK) of ZP8396 (Vz/f)

Time frame:Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3

descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK) of ZP8396 (CL/f)

Time frame:Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3

descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK) of ZP8396 (Ctrough)

Time frame:Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Accumulation Ratio for AUCτ

Time frame:Part 1: Day 1 (pre-dose) to Day 92

AUC₀–∞

descriptive

Secondary/protocol endpoint

Accumulation Ratio for Cmax

Time frame:Part 1: Day 1 (pre-dose) to Day 92

Cmax

ratio, descriptive

Secondary/protocol endpoint

Pharmacodynamics (PD) of ZP8396 (Cmax acetaminophen)

Time frame:Part 1: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40; Part 2: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1, Day 110 for cohort 1 and 2, Day -1, Day 1, Day 107 for cohort 3

Cmax

concentration, descriptive

Secondary/protocol endpoint

Pharmacodynamics (PD) of ZP8396 (Tmax acetaminophen)

Time frame:Part 1: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40; Part 2: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1, Day 110 for cohort 1 and 2, Day -1, Day 1, Day 107 for cohort 3

Tmax

descriptive

Secondary/protocol endpoint

Pharmacodynamics (PD) of ZP8396 (AUCacetaminophen, 0-60 min)

Time frame:Part 1: 0-60 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40; Part 2: 0-60 minutes, relative to ingestion of MTM/acetaminophen on Day -1, Day 110 for cohort 1 and 2, Day -1, Day 1, Day 107 for cohort 3

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Pharmacodynamics (PD) of ZP8396 (AUCacetaminophen, 0-240 min)

Time frame:Part 1: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40; Part 2: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1, Day 110 for cohort 1 and 2, Day -1, Day 1, Day 107 for cohort 3

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Pharmacodynamics (PD) of ZP8396 (Tmax, insulin)

Time frame:Part 1: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40

Tmax

descriptive

Secondary/protocol endpoint

Pharmacodynamics (PD) of ZP8396 (Tmax, glucagon)

Time frame:Part 1: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40

Tmax

descriptive

Other (unclassified)

4 endpoints
Secondary/protocol endpoint/low confidence

Pharmacodynamics (PD) of ZP8396 (AUE, Plasma Glucose [PG], 0-60 minutes)

Time frame:Part 1: 0-60 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40; Part 2: 0-60 minutes, relative to ingestion of MTM/acetaminophen on Day -1, Day 110 for cohort 1 and 2, Day -1, Day 1, Day 107 for cohort 3

concentration, descriptive

Secondary/protocol endpoint/low confidence

Pharmacodynamics (PD) of ZP8396 (AUE, Plasma Glucose [PG], 0-240 minutes)

Time frame:Part 1: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40; Part 2: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1, Day 110 for cohort 1 and 2, Day -1, Day 1, Day 107 for cohort 3

descriptive

Secondary/protocol endpoint

Pharmacodynamics (PD) of ZP8396 (Emax, glucagon)

Time frame:Part 1: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40

concentration, descriptive

Secondary/protocol endpoint/low confidence

Pharmacodynamics (PD) of ZP8396 (AUEglucagon,0-240 minutes)

Time frame:Part 1: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40

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.