GLP-1 Peptide Atlas, by Delfa

CompletedPhase EARLY_1

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

A First in Human, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Dose of ZP7570 in Healthy Subjects

Lead sponsor

Zealand Pharma

Assets

Dapiglutide / GLP-1 / incretin class catch-all

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 IDNCT03994549

Org study IDZP7570-18144

Secondary ID2019-001128-36

Timeline

Milestones

Study start2019-06-14actual

Study first posted2019-06-21actual

Primary completion2020-11-02actual

Study completion2020-11-02actual

Last update posted2020-12-02actual

Assets

Investigational agents

Dapiglutide GLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Healthy male or female subject aged between 18 and 55 years, both inclusive.

•Body Mass Index (BMI) between 18.5 and 28.0 kg/m^2, both inclusive

•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 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.

•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 as evaluated by the investigator.

•History of severe hypersensitivity to medicines or foods or history of severe medicinal/food induced anaphylactic reaction or contraindication to the use of Indocyanine Green (e.g. hypersensitivity to iodine).

•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 who are not using a highly effective contraceptive method

•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 (25)

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

Cardiometabolic biomarkers

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Pharmacodynamics - Plasma glucose levels

Time frame:Time Frame: 0-240 minutes

Postprandial glucose

descriptive

Secondary/protocol endpoint

Pharmacodynamics - Insulin concentrations

Time frame:Time Frame: 0-240 minutes

concentration, descriptive

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Safety - Vital signs, blood pressure

Time frame:From time zero to 28 days after dosing

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Safety - Vital signs, pulse

Time frame:From time zero to 28 days after dosing

Heart rate, change

change from baseline, improvement

Safety / tolerability / PK

21 endpoints

Primary/protocol endpoint

Safety - Incidence of adverse events (AEs)

Time frame:From time zero to 28 days after dosing

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Pharmacokinetics - Area under the plasma concentration-time curve trough

Time frame:From time zero up to day 28

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics - Area under the plasma concentration-time curve infinity

Time frame:From time zero up to day 28

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics - Area under the plasma concentration-time curve last

Time frame:From time zero up to day 28

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics - Maximum plasma concentration

Time frame:From time zero to 28 days after dosing

Cmax

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics - Time to maximum plasma concentration (Tmax)

Time frame:From time zero to 28 days after dosing

Tmax

descriptive

Secondary/protocol endpoint

Pharmacokinetics - Half-life , t½

Time frame:From time zero to 28 days after dosing

Half-life

descriptive

Secondary/protocol endpoint

Pharmacokinetics - Volume of distribution

Time frame:From time zero to 28 days after dosing

descriptive

Secondary/protocol endpoint

Pharmacokinetics - Mean residence time

Time frame:From time zero to 28 days after dosing

descriptive

Secondary/protocol endpoint

Pharmacokinetics - Body clearance

Time frame:From time zero to 28 days after dosing

descriptive

Secondary/protocol endpoint

Pharmacokinetics - Elimination rate constant

Time frame:From time zero to 28 days after dosing

descriptive

Secondary/protocol endpoint

Pharmacodynamics - Plasma acetaminophen concentration-time curves

Time frame:Time Frame: 0-240 minutes

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Pharmacodynamics - Maximum acetaminophen concentration

Time frame:Time Frame: 0-240 minutes

Cmax

concentration, descriptive

Secondary/protocol endpoint

Pharmacodynamics - Time maximum acetaminophen concentration

Time frame:Time Frame: 0-240 minutes

Tmax

descriptive

Secondary/protocol endpoint

Safety - Safety lab, haematology

Time frame:From time zero to 28 days after dosing

descriptive

componentshematocrit, hemoglobin, erythrocyte count, mcv, mch, mchc, platelet count, leukocyte count, neutrophil count absolute, neutrophil percent, lymphocyte count absolute, lymphocyte percent, monocyte count absolute, monocyte percent, eosinophil count absolute, eosinophil percent, basophil count absolute, basophil percent

Secondary/protocol endpoint

Safety - Safety lab, clinical chemistry

Time frame:From time zero to 28 days after dosing

change from baseline, descriptive

componentsALT, change, AST, change, γ-GT, change, Total cholesterol, change, LDL-C, change, HDL-C, change, Triglycerides, change

Secondary/protocol endpoint

Safety - Safety lab, urinalysis

Time frame:From time zero to 28 days after dosing

descriptive

Secondary/protocol endpoint

Safety - Physical examination

Time frame:From time zero to 28 days after dosing

descriptive

Secondary/protocol endpoint

Safety - ECG

Time frame:From time zero to 28 days after dosing

descriptive

Secondary/protocol endpoint

Safety - Occurrence of Injection site reactions

Time frame:From time zero to 28 days after dosing

event count, event

Secondary/protocol endpoint

Safety - Immunogenicity: Occurrence of anti-drug antibodies

Time frame:From time zero to 28 days after dosing

Immunogenicity (ADA)

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.