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

NCT07721597 | Recruiting Early Phase 1

• 1 other identifier: ZP6590-26033
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Participants Study; Overweight and Obese Adults; First in Man Study to Evaluate Initial Safety

Keywords

ZP6590; Safety and Tolerability; GIP-R agonist; obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection

  SAD-Part: From Day 1 to Day 29

• To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection

  SAD Part: From Day 1 to Day 29

• To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection

  SAD-Part: From Day 1 to Day 29

• To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection

  SAD-Part: From Day 1 to Day 29

• To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection

  SAD-Part: From Day 1 to Day 29

Study Arms (2)

Drug: ZP6590, solution for injection

ACTIVE COMPARATOR

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

Drug: ZP6590, solution for injection

Placebo, solution for injections

PLACEBO COMPARATOR

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

Drug: Placebo, solution for injection

Interventions

ZP6590, solution for injection DRUG

Participants will receive single or multiple subcutaneous dose administrations of ZP6590.

Drug: ZP6590, solution for injection

Placebo, solution for injection DRUG

Participants will receive single or multiple subcutaneous dose administrations of Placebo.

Placebo, solution for injections

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Male: People who were assigned male at birth based on their physical characteristics.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand Pharma: lead

Study Sites (1)

Profil, Institut für Stoffwechselforschung GmbH

Neuss, North Rhine-Westphalia, 41460, Germany

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Solutions; Injections

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Ulrike Hövelmann

  Profil Institut für Stoffwechselforschung GmbH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Regulatory Affairs Department Regulatory Affairs Department, MDRA

CONTACT

+49213140180; clinicaltrialservices@profil.com

Regulatory Affairs Department Regulatory Affairs Department

CONTACT

+49213140180; clinicaltrialservices@profil.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Trial safety group is masked to make decision on dose escalation.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, double-blind within cohorts, placebo-controlled, sequential single and multiple ascending dose trial.

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 23, 2026
• Study Start: July 9, 2026
• Primary Completion (Estimated): September 6, 2027
• Study Completion (Estimated): September 6, 2027
• Last Updated: July 23, 2026

Record last verified: 2026-07

Locations

DE (1)