Recruiting

Safety and Tolerability Assessment of ZP6590 in Adults with Normal Weight, Overweight and Obesity

Study Aim

This study aims to evaluate the safety and tolerability of ZP6590 in adults with normal weight, overweight, and obesity, by observing the incidence of treatment-emergent adverse events from the first dose to the end of the trial.

What is being tested

ZP6590, solution for injection

+ Placebo, solution for injection

Drug

Who is being recruted

Body Weight+5

+ Nutrition Disorders

+ Nutritional and Metabolic Diseases

From 18 to 60 Years

+10 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledEarly Phase 1

Interventional

Study Start: July 2026

See protocol details

Summary

Principal SponsorZealand Pharma

Study ContactRegulatory Affairs Department Regulatory Affairs Department, MDRAMore contacts

Last updated: July 23, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 9, 2026

Actual date on which the first participant was enrolled.

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.

NCT07721597

Principal SponsorZealand Pharma

Study ContactRegulatory Affairs Department Regulatory Affairs Department, MDRAMore contacts

Last updated: July 23, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

88 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionObesityOverweight

Criteria

7 inclusion criteria required to participate

Age between 18 and 55 years, both inclusive

Age between 18 and 60 years, both inclusive

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

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

Show More Criteria

3 exclusion criteria prevent from participating

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

SAD-Part and MAD-Part

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator

ZP6590 will be administered as single dose administration and as multiple dose administrations.

Group II

Placebo

Placebo will be administered as single dose administration and as multiple dose administrations.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Profil, Institut für Stoffwechselforschung GmbH

Neuss, GermanyOpen Profil, Institut für Stoffwechselforschung GmbH in Google Maps

Recruiting

One Study Center