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

ConditionsHealthy Participants StudyOverweight and Obese AdultsFirst in Man Study to Evaluate Initial Safety
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexMale
Age18-60
SponsorZealand Pharma

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male participant

Age between 18 and 55 years, both inclusive

Body Mass Index (BMI) between 20.0 and 29.9 kg/m², both inclusive

Male participant

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • ZP6590, solution for injection

    Drug

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

  • Placebo, solution for injection

    Drug

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

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: Drug: ZP6590, solution for injectionActive comparator 1 intervention
Group B: Placebo, solution for injectionsPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zealand Pharma

Lead sponsor

Source ClinicalTrials.gov
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