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

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.

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