An Early Phase 1 interventional study of ZP6590, solution for injection and Placebo, solution for injection in Healthy Participants Study, Overweight and Obese Adults and First in Man Study to Evaluate Initial Safety, sponsored by Zealand Pharma. Recruiting at 1 site in Germany. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Zealand Pharma · Early Phase 1, Interventional, and Treatment
The goal of this clinical trial is to learn about the safety and tolerability of drug ZP6590 and to learn how the body processes the drug ZP6590 in adults. The main questions it aims to answer are:
In the first Part of the study:
Participants will:
In the second Part of the study:
Participants will:
The main objective of this randomized, double-blind, placebo-controlled trial is to assess the safety and tolerability of drug ZP6590 as single ascending doses and multiple ascending doses in healthy participants living with normal weight, overweight and obesity.
In addition, the study will investigate the pharmacokinetics of the drug ZP6590.
The trial is divided in two parts:
SAD-Part 1: Participants will be administered a single subcutaneous dose of the drug ZP6590 or placebo and will have an observation period of 4 weeks.
MAD-Part 2: Participants will be administered multiple dosages of the drug ZP6590 or placebo for 6 or 12 weeks followed by an observation period of 6 weeks after last dosing.
After informed consent has been obtained, eligibility of the participants will be assessed during a screening visit.
SAD- and MAD-Part: Eligible participants will be admitted to the site in the morning on Day before dosing and will have ambulatory visits or remain under in-house conditions after dosing.
Safety evaluation for dose escalation:
The safety and exposure assessments of each cohort will take place before dose escalation to the next dose level will start.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 88 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Zealand Pharma is the lead sponsor of 43 studies on the registry; 5 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 8 (47%) have results posted.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
SAD-Part:
MAD-Part:
Exclusion Criteria:
SAD-Part and MAD-Part:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ZP6590 will be administered as single dose administration and as multiple dose administrations.
Drug: ZP6590, solution for injection
Placebo will be administered as single dose administration and as multiple dose administrations.
Drug: Placebo, solution for injection
Participants will receive single or multiple subcutaneous dose administrations of ZP6590.
Participants will receive single or multiple subcutaneous dose administrations of Placebo.
Safety and Tolerability
Incidence of treatment emergent adverse events (TEAEs) from first dose to end of trial
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
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
Area under the plasma concentration versus time curve from 0 to infinity (AUCinf)
Time frame: SAD-Part: From Day 1 to Day 29
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
Area under the plasma concentration versus time curve from 0 to last (AUClast)
Time frame: SAD Part: From Day 1 to Day 29
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
Peak Plasma Concentration (Cmax)
Time frame: SAD-Part: From Day 1 to Day 29
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
Time to Peak Plasma Concentration (Tmax)
Time frame: SAD-Part: From Day 1 to Day 29
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
Terminal rate constant (λz)
Time frame: SAD-Part: From Day 1 to Day 29
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
Terminal half-life (t½)
Time frame: SAD-Part: From Day 1 to Day 29
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
Apparent volume of distribution during terminal phase (Vz/f)
Time frame: SAD-Part: From Day 1 to Day 29
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
apparent total clearance of ZP6590 from plasma for SAD cohorts (CL/f)
Time frame: SAD-Part: From Day 1 to Day 29
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Area under the plasma concentration versus time curve from 0 to trough (AUCτ)
Time frame: MAD-Part: After 1st and 4th doses (6-Weeks and 12-Weeks Cohorts) and after 6th dose (12-Weeks Cohort), dosing interval in hours.
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Peak Plasma Concentration (Cmax)
Time frame: MAD-Part: After 1st and 4th doses (6-Weeks and 12-Weeks Cohorts) and after 6th dase (12-Weeks Cohort), dosing interval in hours
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Time to Peak Plasma Concentration (Tmax)
Time frame: MAD-Part: After 1st and 4th doses (6-Weeks and 12-Weeks Cohorts) and after 6th dase (12-Weeks Cohort), dosing interval in hours
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Trough concentration measured predose for MAD cohorts (Cτ)
Time frame: MAD-Part: After 2nd, 3rd, 4th, 5th doses (6-Weeks Cohorts and 12-Weeks Cohort) and 6th, 7th, 8th, 9th, 10th, 11th and 12th doses (12-Weeks Cohort)
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Area under the plasma concentration versus time curve from 0 to infinity (AUCinf)
Time frame: MAD-Part: After 6th (6-Weeks Cohorts) and 12th (12-Weeks-Cohort) doses
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Area under the plasma concentration versus time curve from 0 to last (AUClast)
Time frame: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Peak Plasma Concentration (Cmax)
Time frame: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Time to Peak Plasma Concentration (Tmax)
Time frame: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Terminal rate constant (λz)
Time frame: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Terminal half-life (t½)
Time frame: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Apparent volume of distribution during terminal phase (Vz/f)
Time frame: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Apparent total clearance of ZP6590 from plasma at steady state (SS) for MAD-cohorts (CLss/f)
Time frame: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Mean residence time of plasma ZP6590 concentration at steady state (SS) for MAD cohorts (MRTss)
Time frame: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Sep 2027, 13 months after the start.
Of 334 industry-sponsored phase 1 interventional studies under Obesity, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 15. This study's planned 13 months is above that.
Counting every sponsor, half of 439 studies reached it within 11 months; a quarter within 6 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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