A Research Study of a New Medicine NNC0113-6856 in Healthy Males

NCT05521256 · Completed

Last updated 2026-05-28

This study tests a new experimental medicine called NNC0113-6856 in healthy adult men to evaluate its safety and side effects.

Status Completed The study has finished.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 70 people

Who can join Ages 18–55 · male only Healthy volunteers accepted.

Timeline Started 2022-08 · est. completion 2023-03

Where 3 sites · Germany

What this study is testing ClinicalTrials.gov NCT05521256 ↗

Description as written by the study sponsor.

In this study NN0113-6856 will be given to humans for the first time. We will be looking into how safe different single doses of the new investigational product NNC0113-6856 is and we will measure its amount as well as the amount of specific parts of the new investigational product in blood. The study will look at the effects of different single doses of NNC0113-6856. This could either be as an oral dose (cohort 1 to 5) or one injection into the vein (intravenous \[IV\]-cohort). Participant will get the investigational product either as one or two tablets (oral dose in cohort 1 to 5) or as injection into the vein (IV cohort). The study will last for about 6-10 weeks (up to 14 weeks in case of rescheduling for stand-by participants).

Treatments tested

NNC0113-6856 Drug

Participants will receive NN0113-6856 orally or intravenously.
Placebo Drug

Participants will receive matching placebo of NNC0113-6856 for each of the oral cohorts.

Main thing measured	Number of adverse events
Sponsor	Novo Nordisk A/S
Conditions studied	Healthy Volunteers, Type 2 Diabetes
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05521256 ↗