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TerminatedPhase 1

A Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP7570

A Randomised, Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP7570 Administered in Subjects With Overweight or Obesity

Lead sponsor

Zealand Pharma

Assets

Dapiglutide / GLP-1 / incretin class catch-all

Listed sites

1

Recruiting sites

Enrollment

84

actual

Study population

Obesity / overweight

Key I/E criterion

BMI 27-39.9

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 IDNCT06000891
Org study IDZP7570-23012
Secondary ID2022-500614-26

Timeline

Milestones

Study first posted2023-08-21actual
Study start2023-09-15actual
Primary completion2025-02-11actual
Study completion2025-03-21actual
Last update posted2025-04-25actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age64 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

Age between 18 and 64 years, both inclusive.
Body Mass Index (BMI) between 27.0 and 39.9 kg/m^2, both inclusive.
In overall good health according to age (medical history, physical and neurological examination, vital signs, and laboratory assessments), as judged by the investigator at screening.

Exclusion criteria

History of gastrointestinal (GI) diseases including functional complaints that could interfere with the pharmacokinetics of the IMP or auxiliary medicinal product (acetaminophen) of the trial.
Any relevant abnormal renal parameters in the following ranges:

Serum creatinine above UNL+10% or normalised estimated glomerular filtration rate (eGFR) below 60.0 l/min/1.73m2, as defined by CKD-EPI.

Endpoints (11)

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
9
Weight & body composition
2

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Absolute change in body weight

Time frame:Day 1 and Day 92 in Part 1. Day 1 and Day 197 in Part 2.

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percent change in body weight

Time frame:Day 1 and Day 92 in Part 1. Day 1 and Day 197 in Part 2.

Body weight, % change

percent change from baseline, improvement

Safety / tolerability / PK

9 endpoints
Primary/protocol endpoint

Incidence of treatment emergent adverse events (TEAEs)

Time frame:Day 1 to Day 127 in Part 1. Day 1 to Day 232 in Part 2

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Pharmacokinetics endpoints related to ZP7570 exposure

Time frame:Area under the drug concentration curve from baseline (Day 1) to 18 weeks (Day 127) in Part 1 and to 33 weeks (Day 232) in Part 2.

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics endpoints related to ZP7570 exposure

Time frame:Maximum drug concentration (Cmax) from baseline (Day 1) to 18 weeks (Day 127) in Part 1 and to 33 weeks (Day 232) in Part 2.

Cmax

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics endpoints related to ZP7570 exposure

Time frame:Time to maximum plasma concentration from baseline (Day 1) to 18 weeks (Day 127) in Part 1 and to 33 weeks (Day 232) in Part 2.

Tmax

descriptive

Secondary/protocol endpoint

Pharmacokinetics endpoints related to ZP7570 exposure

Time frame:Elimination rate constant from baseline baseline (Day 1) to 18 weeks (Day 127) in Part 1 and to 33 weeks (Day 232) in Part 2.

descriptive

Secondary/protocol endpoint

Pharmacokinetics endpoints related to ZP7570 exposure

Time frame:Elimination half-life from baseline baseline (Day 1) to 18 weeks (Day 127) in Part 1 and to 33 weeks (Day 232) in Part 2.

Half-life

descriptive

Secondary/protocol endpoint

Pharmacokinetics endpoints related to ZP7570 exposure

Time frame:Apparent volume of distribution from baseline baseline (Day 1) to 18 weeks (Day 127) in Part 1 and to 33 weeks (Day 232) in Part 2.

descriptive

Secondary/protocol endpoint

Pharmacokinetics endpoints related to ZP7570 exposure

Time frame:Apparent total clearance of the drug from plasma from baseline baseline (Day 1) to 18 weeks (Day 127) in Part 1 and to 33 weeks (Day 232) in Part 2.)

descriptive

Secondary/protocol endpoint

Pharmacokinetics endpoints related to ZP7570 exposure

Time frame:Trough concentration measured from baseline baseline (Day 1) to 18 weeks (Day 127) in Part 1 and to 33 weeks (Day 232) in Part 2.

Plasma concentration (steady state)

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.