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

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:

• Is the drug ZP6590 safe and well tolerated when administered as escalating single and multiple doses of the ZP6590?
• How quickly and to what extent the administered investigational drug is absorbed and distributed, and how long it takes to be eliminated from the body?

In the first Part of the study:

Participants will:

• Get a single ascending dose of the drug ZP6590 or placebo and will have an observation period of 4 weeks.

In the second Part of the study:

Participants will:

• Get multiple dosages of the drug ZP6590 or placebo for 6 or 12 weeks followed by an observation period of 6 weeks after last dosing.

Study Overview

• Status: Recruiting
• Conditions: Healthy Participants Study; First in Man Study to Evaluate Initial Safety; Overweight and Obese Adults
• Intervention / Treatment: Drug: ZP6590, solution for injection; Drug: Placebo, solution for injection

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Regulatory Affairs Department Regulatory Affairs Department, MDRA; Phone Number: +49213140180; Email: clinicaltrialservices@profil.com
• Study Contact Backup: Name: Regulatory Affairs Department Regulatory Affairs Department; Phone Number: +49213140180; Email: clinicaltrialservices@profil.com

Study Locations

• Germany
  • North Rhine-Westphalia
    • Neuss, North Rhine-Westphalia, Germany, 41460
      • Recruiting
      • Profil, Institut für Stoffwechselforschung GmbH
      • Contact: Regulatory Affairs Department Regulatory Affairs Department; Phone Number: +49213140180; Email: clinicaltrialservices@profil.com
      • Contact: Project Management Project Management; Phone Number: +49213140180; Email: clinicaltrialservices@profil.com
      • Principal Investigator: Ulrike Hövelmann, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Drug: ZP6590, solution for injection; ZP6590 will be administered as single dose administration and as multiple dose administrations.	Drug: ZP6590, solution for injection; Participants will receive single or multiple subcutaneous dose administrations of ZP6590.
Placebo Comparator: Placebo, solution for injections; 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 Placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability	Incidence of treatment emergent adverse events (TEAEs) from first dose to end of trial	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection	Area under the plasma concentration versus time curve from 0 to infinity (AUCinf)	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)	SAD Part: From Day 1 to Day 29
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection	Peak Plasma Concentration (Cmax)	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)	SAD-Part: From Day 1 to Day 29
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection	Terminal rate constant (λz)	SAD-Part: From Day 1 to Day 29
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection	Terminal half-life (t½)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses

Collaborators and Investigators

• Sponsor: Zealand Pharma
• Investigators: Principal Investigator: Ulrike Hövelmann, Profil Institut für Stoffwechselforschung GmbH

Study record dates

Study Major Dates

• Study Start (Estimated): July 9, 2026
• Primary Completion (Estimated): September 6, 2027
• Study Completion (Estimated): September 6, 2027

Study Registration Dates

• First Submitted: July 16, 2026
• First Submitted That Met QC Criteria: July 22, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 22, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: obesity; Safety and Tolerability; ZP6590; GIP-R agonist
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Pharmaceutical Preparations; Therapeutics; Drug Administration Routes; Drug Therapy; Injections; Solutions
• Other Study ID Numbers: ZP6590-26033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No