A Phase 1 Study to Evaluate Safety and Effects of Single Subcutaneous Doses of NNC4005-0001 in Adults with Fatty Liver Disease and Increased Body Weight

What this Trial Is About

Researchers are evaluating the safety and tolerability of a new medicine called NNC4005-0001 in adults who have increased body weight and liver fat, specifically those with fatty liver disease. This early phase 1 clinical trial aims to understand how the medicine behaves in the body and whether it causes any side effects. The study is sponsored by Novo Nordisk AS and is designed as a randomized, double-blind, placebo-controlled trial to ensure reliable results. Participants will receive a single injection of either NNC4005-0001 or a matching placebo under the skin. The trial includes up to six groups with increasing doses of the medicine to assess its effects at different levels. Each participant will only receive one dose, and the study will monitor them closely for about 7 to 8 months. During the study, participants will have various assessments to track safety and how the medicine is processed in the body. Researchers will record any side effects from the day of dosing until the end of the study visit on day 169. Blood samples will be taken to measure the concentration of the medicine over time, including the highest level reached and how quickly it is cleared from the body. The study involves regular visits and evaluations to ensure participant safety and gather important information about the treatment.

A Research Study of a Potential New Medicine (NNC4005-0001) for Liver Disease in Adult Participants With Increased Body Weight and Liver Fat