A Research Study on How NNC0638-0355, a New Medicine, Works in People Living With Overweight or Obesity

Launched by NOVO NORDISK A/S · Aug 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called NNC0638-0355, which aims to help people who are living with overweight or obesity. The main goals of the study are to find out if this medicine is safe and how it works in your body. Participants in the trial will receive either the new medicine or a placebo, which is a "dummy" treatment that looks like the real medicine but doesn’t contain any active ingredients. Participants will receive these treatments through an injection under the skin, and which one you get will be decided randomly.

To be eligible for the study, you should be between 18 and 55 years old and have a body mass index (BMI) between 25.0 and 34.9, which means you are considered overweight. You also need to be generally healthy, with no serious medical conditions that could affect your safety during the study. If you decide to participate, you can expect to undergo some medical tests to ensure you qualify, and you will be closely monitored throughout the trial. It's important to note that this new medicine is still being tested and is not yet available for doctors to prescribe.

Gender

ALL

Eligibility criteria

• • Key inclusion criteria
• • Male or female.
• • Age 18-55 years (both inclusive) at the time of signing the informed consent.
• • BMI between 25.0 and 34.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
• • Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
• • Key exclusion criteria
• • Known or suspected hypersensitivity to study intervention(s) or related products.
• • Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
• • HbA1c greater than or equal to 6.5 percentage (48 mmol/mol) at screening.
• * Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:
• • 1. Vitamin D (25-hydroxycholecalciferol) less than 12 ng/mL (30 nM) at screening
• • 2. Parathyroid hormone (PTH) outside normal range at screening
• • 3. Total calcium outside normal range at screening