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

Early Phase 1RecruitingNCT07721597

Zealand Pharma88 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

Eligibility

Sex: MALEMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

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

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

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

To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection

Terminal rate constant (λz)

Time frame: SAD-Part: From Day 1 to Day 29

To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection

Terminal half-life (t½)

Time frame: 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)

Time frame: 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)

Time frame: SAD-Part: From Day 1 to Day 29