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

Condition(s) studied

Investigational drug(s) / intervention(s)

ZP6590, solution for injection: Participants will receive single or multiple subcutaneous dose administrations of ZP6590.

Placebo, solution for injection: Participants will receive single or multiple subcutaneous dose administrations of Placebo.

Study 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.

Eligibility

Primary outcome measure(s)

• Safety and Tolerability — 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
  Incidence of treatment emergent adverse events (TEAEs) from first dose to end of trial

Trial sites (1)

More Zealand Pharma trials in Germany