Loading clinical trials...

A Research Study of a New Medicine NNC0113-6856 in Healthy Males | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A First Human Dose Study Investigating Safety, Tolerability, and Pharmacokinetics of Oral Single Doses of NNC0113-6856 in Healthy Male Participants

NCT05521256•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

18 - 55 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•Male.
•Aged 18-55 years (both inclusive) at the time of signing informed consent.
•Body mass index between 20.0 and 27.0 kilogram per meter square (kg/m\^2)(both inclusive).

Exclusion Criteria

•Glycated haemoglobin (HbA1c) greater than or equal to (\>=) 6.5 percent (%) (48 millimoles per moles \[mmol/mol\]) at screening.
•Use of tobacco and nicotine products, defined as any of the below:
•* Smoking more than 5 cigarettes or the equivalent per day.
•* Not willing to refrain from smoking and use of nicotine substitute products during the inpatient periods.
•Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.
•History of major surgical procedures involving the stomach potentially affecting absorption of trial products (example: subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant
•Presence or history of pancreatitis (acute or chronic).
•Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
•Any of the below laboratory safety parameters at screening outside the below laboratory range, see "Log of laboratory ranges used for laboratory parameter exclusion criterion" for specific values:
•* Alanine Aminotransferase (ALT) greater than (\>) upper normal limit (UNL)
+5 more criteria

Locations (3)

Profil Institut für Stoffwechselforschung GmbH

Neuss, North Rhine-Westphalia, Germany

Profil GmbH & Co. KG

Mainz, Germany

Profil Institut für Stoffwechselforschung GmbH

Neuss, Germany

Key Dates

Start Date

August 26, 2022

Primary Completion Date

March 27, 2023

Completion Date

March 27, 2023

Last Updated

December 31, 2025

Enrollment

ACTUAL participants

Conditions

Healthy VolunteersType 2 Diabetes

Interventions

NNC0113-6856

DRUG

Placebo

DRUG

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

NCT07310264

Healthy Volunteers (HV)Parkinson's Disease (PD)

View study

RECRUITINGNA

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 31, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

Feasibility of a Tailored Online Self-compassion Intervention

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

iGlarLixi CGM Study in Chinese T2D Individuals After OADs

High Intensity Interval Training and Insulin Sensitivity in Type 2 Diabetes