RecruitingPhase EARLY_1

A Single and Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP6590 in Participants With Normal Weight, Overweight and Obesity

A First-in-human, Randomized, Single and Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP6590 in Participants With Normal Weight, Overweight and Obesity

Lead sponsor

Zealand Pharma

Asset

ZP6590

Subcutaneous · GIP agonist

Listed sites

Recruiting sites

Estimated enrollment

Study population

Healthy volunteers, Obesity / overweight

Eligibility highlights

•BMI 20-29.9•Male

Primary endpoint

•Safety and Tolerability

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07721597

Org study IDZP6590-26033

Timeline

Milestones

Study start2026-07-09actual

Study first posted2026-07-23actual

Last update posted2026-08-13actual

Primary completion2027-09-06estimated

Study completion2027-09-06estimated

Assets

Investigational agents

ZP6590

Who this study enrolls

Healthy volunteersObesity / overweight

Who can enroll

Minimum age18 Years

Maximum age60 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

SAD-Part:

•Male participant

•Age between 18 and 55 years, both inclusive

•Body Mass Index (BMI) between 20.0 and 29.9 kg/m^2, both inclusive

MAD-Part:

•Male participant

•Age between 18 and 60 years, both inclusive

•Body Mass Index (BMI) between 27.0 and 39.9 kg/m^2, both inclusive

Exclusion criteria

SAD-Part and MAD-Part:

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

•Treatment for weight management within 3 months before randomization in this trial

Endpoints (22)

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.

Safety / tolerability / PK

22 endpoints

Primary/protocol endpoint

Safety and Tolerability

Time frame:Single ascending Dose (SAD)-Part: From Day 1 to Day 29 (4 weeks) Multiple ascending Dose (MAD)-Part: MAD-cohorts (6-Weeks): From Day 1 to Day 78 MAD-cohort (12-Weeks): Day 1 to Day 120

descriptive

Secondary/protocol endpoint

To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection

Time frame:SAD-Part: From Day 1 to Day 29

descriptive

Secondary/protocol endpoint

To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection

Time frame:SAD Part: From Day 1 to Day 29

descriptive

Secondary/protocol endpoint

To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection

Time frame:SAD-Part: From Day 1 to Day 29

descriptive

Secondary/protocol endpoint

To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection

Time frame:SAD-Part: From Day 1 to Day 29

descriptive

Secondary/protocol endpoint

To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection

Time frame:SAD-Part: From Day 1 to Day 29

descriptive

Secondary/protocol endpoint

To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection

Time frame:SAD-Part: From Day 1 to Day 29

descriptive

Secondary/protocol endpoint

To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection

Time frame:SAD-Part: From Day 1 to Day 29

descriptive

Secondary/protocol endpoint

To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection

Time frame:SAD-Part: From Day 1 to Day 29

descriptive

Secondary/protocol endpoint