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HealthyEarly Phase 1NCT03994549

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

A Early Phase 1 study testing Dual GLP-1/GLP-2 Receptor agonists in people with Healthy, run by Zealand Pharma at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, double-blind, placebo-controlled, single ascending dose trial in healthy subjects, randomized to ZP7570 or placebo within each cohort. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Dual GLP-1/GLP-2 Receptor agonists
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
1 siteGermany
Study dates
14 Jun 2019to 2 Nov 2020
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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).
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  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Profil Institut für Stoffwechselforschung GmbH

    Neuss, North Rhine-Westphalia, 41460

Other trials in Germany

About this study

Official title: 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

This is a randomized, double-blind, placebo-controlled, single ascending dose trial in healthy subjects, randomized to ZP7570 or placebo within each cohort.

Read the detailed description

Sixty-four subjects are planned to be studied in eight cohorts in this first-in human trial. Eight subjects will be allocated to the to eight dose levels. The entire observation period comprise 28 days starting with a 96 hours in-house stay, where discharge is planned for Day 5, followed by five outpatient visits and an End of Trial Visit at Day 28. A blinded evaluation of each cohort will be performed by a Trial Safety Group to determine whether the trial will progress to the next dose level based on the stopping rules specified in protocol.

Conditions
Healthy
Being tested
Dual GLP-1/GLP-2 Receptor agonists
Keywords
Dual GLP-1R/GLP-2 Receptor agonist

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dual GLP-1/GLP-2 Receptor agonistsDrug

    Also called ZP7570

    Eight ascending doses of ZP7570

Study groups in NCT03994549
Study groupRoleWhat they receive
ZP7570Active comparatorSingle subcutaneous injection
Receives: Drug: Dual GLP-1/GLP-2 Receptor agonists
PlaceboPlacebo comparatorSingle subcutaneous injection
Receives: Drug: Dual GLP-1/GLP-2 Receptor agonists

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety - Incidence of adverse events (AEs)

    The incidence, type and severity of adverse events (AEs)

    Measured: From time zero to 28 days after dosing

Secondary outcomes (24)

  1. Pharmacokinetics - Area under the plasma concentration-time curve trough

    AUCτ, Area under the plasma concentration-time curve (AUC) from zero up to trough concentration.

    Measured: From time zero up to day 28

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

    AUCinf, Area under the plasma concentration-time curve (AUC) from zero up to last concentration.

    Measured: From time zero up to day 28

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

    AUClast, Area under the plasma concentration-time curve (AUC) from zero up to last concentration

    Measured: From time zero up to day 28

  4. Pharmacokinetics - Maximum plasma concentration

    Measured maximum plasma drug concentration after dosing, Cmax

    Measured: From time zero to 28 days after dosing

  5. Pharmacokinetics - Time to maximum plasma concentration (Tmax)

    Sampling time until reaching Cmax, Tmax

    Measured: From time zero to 28 days after dosing

  6. Pharmacokinetics - Half-life , t½

    Half-life of ZP7570, t½

    Measured: From time zero to 28 days after dosing

  7. Pharmacokinetics - Volume of distribution

    Apparent volume of distribution of ZP7570, Vz/f

    Measured: From time zero to 28 days after dosing

  8. Pharmacokinetics - Mean residence time

    Mean residence time, MRT

    Measured: From time zero to 28 days after dosing

  9. Pharmacokinetics - Body clearance

    Total body clearance, CL/f

    Measured: From time zero to 28 days after dosing

  10. Pharmacokinetics - Elimination rate constant

    Elimination rate constant, λz

    Measured: From time zero to 28 days after dosing

  11. Pharmacodynamics - Plasma glucose levels

    Plasma glucose levels included with the acetaminophen at specific timepoints relative to a Mixed Test Meal

    Measured: Time Frame: 0-240 minutes

  12. Pharmacodynamics - Insulin concentrations

    Insulin concentrations included with the acetaminophen at specific timepoints relative to a Mixed Test Meal

    Measured: Time Frame: 0-240 minutes

  13. Pharmacodynamics - Plasma acetaminophen concentration-time curves

    Plasma acetaminophen concentration-time curves following ingestion of acetaminophen

    Measured: Time Frame: 0-240 minutes

  14. Pharmacodynamics - Maximum acetaminophen concentration

    Change from baseline acetaminophen to maximum acetaminophen

    Measured: Time Frame: 0-240 minutes

  15. Pharmacodynamics - Time maximum acetaminophen concentration

    Time to maximum change in acetaminophen measure from baseline, Tmax

    Measured: Time Frame: 0-240 minutes

  16. Safety - Safety lab, haematology

    Changes in haematology parameters: Haematocrit, Haemoglobin, Erythrocytes, MCV, MCH, MCHC, platelets, Leucocytes, Neutrophile granulocytes (total count and relative), Lymphocytes (total count and relative), Monocytes (total count and relative), Eosinophile granulocytes (total count and relative), Basophile granulocytes (total count and relative)

    Measured: From time zero to 28 days after dosing

  17. Safety - Safety lab, clinical chemistry

    Changes in clinical chemistry parameters: Sodium, Potassium, Calcium, Creatinine, Urea, AST, ALT, gamma-GT, Uric acid, Total protein, Albumin, Total bilirubin, Creatine kinase, Alkaline phosphatase, LDH, Total cholesterol, LDL, HDL, Amylase, Triglycerides, Lipase

    Measured: From time zero to 28 days after dosing

  18. Safety - Safety lab, urinalysis

    Changes in urinalysis: Protein, Glucose Erythrocytes, Leucocytes, pH, ketones

    Measured: From time zero to 28 days after dosing

  19. Safety - Vital signs, blood pressure

    Changes in vital signs, blood pressure (in mmHG)

    Measured: From time zero to 28 days after dosing

  20. Safety - Vital signs, pulse

    Changes in pulse (beats per minute)

    Measured: From time zero to 28 days after dosing

  21. Safety - Physical examination

    Changes in physical examination of body sections (head, chest and heart, abdomen, skin and mucosae, musculoskeletal system, nervous system, lymph node)

    Measured: From time zero to 28 days after dosing

  22. Safety - ECG

    Occurrence of ECG findings, Changes in ECG parameters (in ms). ECG components: Heart rate, PR, QRS, QT and QTcF.

    Measured: From time zero to 28 days after dosing

  23. Safety - Occurrence of Injection site reactions

    Occurrence of injection site reactions

    Measured: From time zero to 28 days after dosing

  24. Safety - Immunogenicity: Occurrence of anti-drug antibodies

    Occurrence of anti-drug antibodies

    Measured: From time zero to 28 days after dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2019
  2. Study start14 Jun 2019
  3. Primary completion2 Nov 2020
  4. Study completion2 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A randomized, double-blind, placebo-controlled, single ascending dose trial in healthy subjects, randomized to ZP7570 or placebo
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03994549
Sponsor's protocol ID
ZP7570-18144
Other IDs
2019-001128-36, 2019
Status last verified
Nov 2020
First submitted
15 May 2019
Last updated
2 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Dual GLP-1/GLP-2 Receptor agonists in people with Healthy, run by Zealand Pharma at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety - Incidence of adverse events (AEs) (time frame: From time zero to 28 days after dosing). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03994549.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2020.

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