GLP-1 Peptide Atlas, by Delfa

CompletedPhase EARLY_1

A Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP7570

A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Subcutaneous Doses of ZP7570 in Healthy Subjects

Lead sponsor

Zealand Pharma

Asset

Dapiglutide

Subcutaneous · GLP-1 / GLP-2 dual

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 18.5-28•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 IDNCT04612517

Org study IDZP7570-18145

Secondary ID2019-001129-29

Timeline

Milestones

Study start2020-10-26actual

Study first posted2020-11-03actual

Primary completion2021-08-30actual

Study completion2021-08-30actual

Last update posted2021-09-02actual

Assets

Investigational agents

Dapiglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Signed and dated informed consent obtained before any trial-related activities. Trial-related activities are any procedures that would not have been done during normal management of the subject.

•Healthy male or female subject (only women not of childbearing potential) aged between 18 and 55 years, both inclusive.

•Body Mass Index (BMI) between 18.5 and 28.0 kg/m2, both inclusive

•A body weight of at least 60 kg.

•Heart rate after 5 minutes rest in supine position inside the range of 50-90 beats/min at screening

Exclusion criteria

•Any history of a disorder which in the investigator's opinion might jeopardize subjects safety, evaluation of results or compliance with the protocol.

•History of gallbladder disease or cholecystectomy.

•History of pancreatitis

•History of major depressive disorder or a Patient Health Questionnaire (PHQ-9) > 9 completed at screening, or a history of other severe psychiatric disorders (e.g. schizophrenia or bipolar disorder).

•Any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to screening.

•Family history of multiple endocrinological neoplasia type 2 (MEN2) or medullary thyroid carcinoma (MTC).

•Clinically significant abnormal standard 12-lead ECG after 5 min resting in supine position at screening, including a QTcF > 450 ms (males) or QTcF > 470 ms (females), PR ≥ 220 ms and QRS ≥ 110 ms.

•History of severe hypersensitivity to medicines or foods or history of severe medicinal/food induced anaphylactic reaction .

•Any clinically significant abnormal hematology, biochemistry, or urinalysis screening tests, as judged by the investigator.

•TSH values outside of normal reference ranges of safety laboratory

•Estimated glomerular filtration rate (eGFR) < 90 ml/min/1.73 m2, as defined by - Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).

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

•Systolic blood pressure < 90 mmHg or >139 mmHg and/or diastolic blood pressure < 50 mmHg or > 89 mmHg (one repeat test will be acceptable in case of suspected white-coat hypertension).

•Symptoms of arterial hypotension

•Women of childbearing potential

•Men with non-pregnant partner(s) of childbearing potential not willing to use male contraception (condom) in addition to a highly effective contraceptive method until 28 days after dosing

•Men with pregnant partner not willing to use male contraception (condom) until 28 days after dosing, in order to avoid exposure of the embryo/fetus to seminal fluid.

Endpoints (50)

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

Cardiometabolic biomarkers

Glycemic / diabetes

Other (unclassified)

Glycemic / diabetes

10 endpoints

Secondary/protocol endpoint

Pharmacodynamics - Plasma glucose concentration-time curves

Time frame:From time 0 to 240 minutes at baseline, 24 hours after a single dose and 24 hours after the the forth dose

Postprandial glucose

descriptive

Secondary/protocol endpoint

Pharmacodynamics - Maximum plasma glucose concentration - Cmax

Time frame:From time 0 to 240 minutes at baseline, 24 hours after a single dose and 24 hours after the the forth dose

Postprandial glucose

concentration, descriptive

Secondary/protocol endpoint

Pharmacodynamics - Time to maximum plasma glucose concentration - Tmax

Time frame:From time 0 to 240 minutes at baseline, 24 hours after a single dose and 24 hours after the forth dose

descriptive

Secondary/protocol endpoint

Pharmacodynamics - Area under the concentration-time curve - AUCplasma glucose,0-60min

Time frame:From time 0 to 60 minutes at baseline, 24 hours after a single dose and 24 hours after the forth dose

Postprandial glucose

concentration, improvement

Secondary/protocol endpoint

Pharmacodynamics - Area under the concentration-time curve - AUCplasma glucose,0-240min

Time frame:From time 0 to 240 minutes at baseline, 24 hours after a single dose and 24 hours after the forth dose

Postprandial glucose

concentration, descriptive

Secondary/protocol endpoint/low confidence

Pharmacodynamics - Insulin concentration-time curves

Time frame:From time 0 to 240 minutes at baseline, 24 hours after a single dose and 24 hours after the forth dose

descriptive

Secondary/protocol endpoint/low confidence

Pharmacodynamics - Area under the concentration-time curve - AUCinsulin,0-60min

Time frame:From time 0 to 60 minutes at baseline, 24 hours after a single dose and 24 hours after the forth dose

C-peptide AUC

concentration, descriptive

Secondary/protocol endpoint

Pharmacodynamics - Area under the concentration-time curve - AUCinsulin, 0-240min

Time frame:From time 0 to 240 minutes at baseline, 24 hours after a single dose and 24 hours after the forth dose

concentration, descriptive

Secondary/protocol endpoint

Pharmacodynamics - Area under the concentration-time curve - AUCglucagon,0-60min (optional)

Time frame:From time 0 to 60 minutes at baseline, 24 hours after a single dose and 24 hours after the forth dose

concentration, descriptive

Secondary/protocol endpoint

Pharmacodynamics - Area under the concentration-time curve - AUCglucagon, 0-240min (optional)

Time frame:From time 0 to 240 minutes at baseline, 24 hours after a single dose and 24 hours after the forth dose

concentration, descriptive

Cardiometabolic biomarkers

12 endpoints

Secondary/protocol endpoint

Pharmacodynamics - Free fatty acids concentration-time curves

Time frame:From time 0 to 240 minutes at baseline, 24 hours after a single dose and 24 hours after the forth dose

Free fatty acids, change

concentration, descriptive

Secondary/protocol endpoint

Pharmacodynamics - Maximum free fatty acids concentration - Cmax

Time frame:From time 0 to 240 minutes at baseline, 24 hours after a single dose and 24 hours after the forth dose

Free fatty acids, change

concentration, descriptive

Secondary/protocol endpoint

Pharmacodynamics - Time to maximum free fatty acids concentration - Tmax

Time frame:From time 0 to 240 minutes at baseline, 24 hours after a single dose and 24 hours after the forth dose

descriptive

Secondary/protocol endpoint

Pharmacodynamics - Area under the concentration-time curve - AUCfree fatty acids, 0-60min

Time frame:From time 0 to 60 minutes at baseline, 24 hours after a single dose and 24 hours after the forth dose

Free fatty acids, change

change from baseline, improvement

Secondary/protocol endpoint

Pharmacodynamics - Area under the concentration-time curve - AUCfree fatty acids, 0-240min

Time frame:From time 0 to 240 minutes at baseline, 24 hours after a single dose and 24 hours after the forth dose

Free fatty acids, change

concentration, descriptive

Secondary/protocol endpoint

Pharmacodynamics - Triglycerides concentration-time curves

Time frame:From time 0 to 240 minutes at baseline, 24 hours after a single dose and 24 hours after the forth dose

Triglycerides, change

descriptive

LOINC 2571-8

Secondary/protocol endpoint

Pharmacodynamics - Maximum triglycerides concentration - Cmax

Time frame:From time 0 to 240 minutes at baseline, 24 hours after a single dose and 24 hours after the forth dose

Triglycerides, change

concentration, descriptive

LOINC 2571-8

Secondary/protocol endpoint

Pharmacodynamics - Time to maximum triglycerides concentration - Tmax

Time frame:From time 0 to 240 minutes at baseline, 24 hours after a single dose and 24 hours after the forth dose

descriptive

LOINC 2571-8

Secondary/protocol endpoint

Pharmacodynamics - Area under the concentration-time curve - AUCtriglycerides, 0-60min

Time frame:From time 0 to 60 minutes at baseline, 24 hours after a single dose and 24 hours after the forth dose

Triglycerides, change

concentration, descriptive

LOINC 2571-8

Secondary/protocol endpoint

Pharmacodynamics - Area under the concentration-time curve - AUCtriglycerides,0-240min

Time frame:From time 0 to 240 minutes at baseline, 24 hours after a single dose and 24 hours after the forth dose

Triglycerides, change

descriptive

Secondary/protocol endpoint

Safety - Vital signs: blood pressure

Time frame:From time 0 to 51 days after first dosing (29 days after fourth dosing)

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Safety - Vital signs: pulse

Time frame:From time 0 to 51 days after first dosing (29 days after fourth dosing)

Heart rate, change

change from baseline, improvement

Safety / tolerability / PK

27 endpoints

Primary/protocol endpoint

Safety and Tolerability - Incidence of treatment emergent adverse events as assessed by type and severity

Time frame:From time 0 to 51 days after first dosing (29 days after fourth dosing) ]

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Pharmacokinetics - Area under the plasma concentration-time curve - through

Time frame:From time 0 to 51 days after first dosing (29 days after fourth dosing)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics - Area under the plasma concentration-time curve - infinity

Time frame:From time 0 to 51 days after first dosing (29 days after fourth dosing)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics - Area under the plasma concentration-time curve - last

Time frame:From time 0 to 51 days after first dosing (29 days after fourth dosing)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics - Maximum plasma concentration - Cmax

Time frame:From time 0 to 51 days after first dosing (29 days after fourth dosing)

Cmax

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics - Time to maximum plasma concentration - Tmax

Time frame:From time 0 to 51 days after first dosing (29 days after fourth dosing)

Tmax

descriptive

Secondary/protocol endpoint/low confidence

Pharmacokinetics - Elimination rate constant - λz

Time frame:From time 0 to 51 days after first dosing (29 days after fourth dosing)

descriptive

Secondary/protocol endpoint

Pharmacokinetics - Half-life - t½

Time frame:From time 0 to 51 days after first dosing (29 days after fourth dosing)

Half-life

descriptive

Secondary/protocol endpoint

Pharmacokinetics - Volume of distribution - Vz/f

Time frame:From time 0 to 51 days after first dosing (29 days after fourth dosing)

descriptive

Secondary/protocol endpoint

Pharmacokinetics - Body clearance - CL/f

Time frame:From time 0 to 51 days after first dosing (29 days after fourth dosing)

descriptive

Secondary/protocol endpoint

Pharmacokinetics - Mean residence time - MRT

Time frame:From time 0 to 51 days after first dosing (29 days after fourth dosing)

descriptive

Secondary/protocol endpoint

Pharmacodynamics - Acetaminophen concentration-time curves

Time frame:From time 0 to 240 minutes at baseline, 24 hours after a single dose and 24 hours after the the forth dose

concentration, descriptive

Secondary/protocol endpoint

Pharmacodynamics - Maximum acetaminophen concentration - Cmax

Time frame:From time 0 to 240 minutes at baseline, 24 hours after a single dose and 24 hours after the the forth dose

Cmax

concentration, descriptive

Secondary/protocol endpoint

Pharmacodynamics - Time to maximum acetaminophen concentration - Tmax

Time frame:From time 0 to 240 minutes at baseline, 24 hours after a single dose and 24 hours after the forth dose

Tmax

descriptive

Secondary/protocol endpoint

Pharmacodynamics - Area under the concentration-time curve - AUCacetaminohen,0-60min

Time frame:From time 0 to 60 minutes at baseline, 24 hours after a single dose and 24 hours after the the forth dose

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Pharmacodynamics - Area under the concentration-time curve - AUCacetaminohen,0-240min

Time frame:From time 0 to 240 minutes at baseline, 24 hours after a single dose and 24 hours after the forth dose

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Pharmacodynamics - Maximum insulin concentration - Cmax

Time frame:From time 0 to 240 minutes at baseline, 24 hours after a single dose and 24 hours after the forth dose

Cmax

concentration, descriptive

Secondary/protocol endpoint

Pharmacodynamics - Time to maximum insulin concentration - Tmax

Time frame:From time 0 to 240 minutes at baseline, 24 hours after a single dose and 24 hours after the forth dose

Tmax

descriptive

Secondary/protocol endpoint

Pharmacodynamics - Maximum glucagon concentration - Cmax (optional)

Time frame:From time 0 to 240 minutes at baseline, 24 hours after a single dose and 24 hours after the forth dose

concentration, descriptive

Secondary/protocol endpoint

Pharmacodynamics - Time to maximum glucagon concentration - Tmax (optional)

Time frame:From time 0 to 240 minutes at baseline, 24 hours after a single dose and 24 hours after the forth dose

Tmax

descriptive

Secondary/protocol endpoint

Anti-ZP7570 antibodies - Incidence and titres

Time frame:From time 0 to 51 days after first dosing (29 days after fourth dosing)

Immunogenicity (ADA)

descriptive

Secondary/protocol endpoint

Safety Lab - Haematological values vs. reference ranges and baseline

Time frame:From time 0 to 51 days after first dosing (29 days after fourth dosing)

descriptive

Secondary/protocol endpoint

Safety Lab - Clinical chemistry values vs. reference ranges and baseline

Time frame:From time 0 to 51 days after first dosing (29 days after fourth dosing)

descriptive

Secondary/protocol endpoint

Safety Lab - Urinalysis values vs. reference ranges and baseline

Time frame:From time 0 to 51 days after first dosing (29 days after fourth dosing)

descriptive

Secondary/protocol endpoint

Safety - Physical Examination

Time frame:From time 0 to 51 days after first dosing (29 days after fourth dosing)

categorical status, descriptive

Secondary/protocol endpoint

Safety - ECG

Time frame:From time 0 to 51 days after first dosing (29 days after fourth dosing)

change from baseline, descriptive

Secondary/protocol endpoint

Safety - Injection site reactions

Time frame:From time 0 to 51 days after first dosing (29 days after fourth dosing)

descriptive, event

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Pharmacodynamics - Glucagon concentration-time curves (optional)

Time frame:From time 0 to 240 minutes at baseline, 24 hours after a single dose and 24 hours after the forth dose

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.