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

December 24, 2025 updated by: Novo Nordisk A/S

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mainz, Germany, 55116
        • Profil GmbH & Co. KG
      • Neuss, Germany, 41460
        • Profil Institut für Stoffwechselforschung GmbH
    • North Rhine-Westphalia
      • Neuss, North Rhine-Westphalia, Germany, 41460
        • Profil Institut für Stoffwechselforschung GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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)
    • Aspartate aminotransferase (AST) > UNL
    • Bilirubin > UNL
    • Creatinine > UNL
    • International normalized ratio (INR) > UNL
  • Precence or history of hepatitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NNC0113-6856 (Oral Cohort)
Participants will receive single oral dose of NNC0113-6856 tablets in dose escalated manner.
Drug: NNC0113-6856
Participants will receive NN0113-6856 orally or intravenously.
Placebo Comparator: Placebo
Participants will receive single oral dose of placebo (NNC0113-6856) tablets in dose escalated manner.
Drug: Placebo
Participants will receive matching placebo of NNC0113-6856 for each of the oral cohorts.
Experimental: NNC0113-6856 (i.v. Cohort)
Participants will receive single dose of 1.5 milligrams (mg) NNC0113-6856 intravenously (i.v.).
Drug: NNC0113-6856
Participants will receive NN0113-6856 orally or intravenously.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of adverse events
Time Frame: From time of dosing (day 1) until completion of the follow-up visit (Day 42)
Measured as number of events.
From time of dosing (day 1) until completion of the follow-up visit (Day 42)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
For oral cohorts- AUC0-tz,sema,single dose (SD): Area under the semaglutide plasma concentration-time curve from time 0 to tz after a single dose, where tz is the time of last quantifiable concentration
Time Frame: From pre-dose (day 1) to completion of follow-up visit (Day 42)
Measured in hours*nanomoles per liter (h*nmol/L).
From pre-dose (day 1) to completion of follow-up visit (Day 42)
For oral cohorts- AUC0-infinity (∞),sema,SD: Area under the semaglutide plasma concentration-time curve from time 0 to infinity after a single dose
Time Frame: From pre-dose (day 1) to completion of follow-up visit (Day 42)
Measured in hours*nanomoles per liter (h*nmol/L).
From pre-dose (day 1) to completion of follow-up visit (Day 42)
For oral cohorts- Cmax,sema,SD: Maximum observed plasma concentration of semaglutide after a single dose
Time Frame: From pre-dose (day 1) to completion of follow-up visit (day 42)
Measured in nanomoles per liter (nmol/L).
From pre-dose (day 1) to completion of follow-up visit (day 42)
For oral cohorts- tmax,sema,SD: Time to maximum observed concentration of semaglutide after a single dose
Time Frame: From pre-dose (day 1) to completion of follow-up visit (day 42)
Measured in hours (h).
From pre-dose (day 1) to completion of follow-up visit (day 42)
For oral cohorts- t½,sema,SD: Terminal half-life of semaglutide after a single dose
Time Frame: From pre-dose (day 1) to completion of follow-up visit (day 42)
Measured in hours (h).
From pre-dose (day 1) to completion of follow-up visit (day 42)
For oral cohorts- AUC0-tz,6856,SD: Area under the NNC0113-6856 plasma concentration-time curve from time 0 to tz after a single dose, where tz is the time of last quantifiable concentration
Time Frame: From pre-dose (day 1) to completion of visit 5 (day 22)
Measured in hours*nanomoles per liter (h*nmol/L).
From pre-dose (day 1) to completion of visit 5 (day 22)
For oral cohorts- AUC0-∞,6856,SD: Area under the NNC0113-6856 plasma concentration-time curve from time 0 to infinity after a single dose
Time Frame: From pre-dose (day 1) to completion of visit 5 (day 22)
Measured as hours*nanomoles per liter (h*nmol/L).
From pre-dose (day 1) to completion of visit 5 (day 22)
For oral cohorts- Cmax,6856,SD: Maximum observed plasma concentration of NNC0113-6856 after a single dose
Time Frame: From pre-dose (day 1) to completion of visit 5 (day 22)
Measured as nanomoles per liter (nmol/L).
From pre-dose (day 1) to completion of visit 5 (day 22)
For oral cohorts- tmax,6856,SD: Time to maximum observed concentration of NNC0113-6856 after a single dose
Time Frame: From pre-dose (day 1) to completion of visit 5 (Day 22)
Measured in hours (h).
From pre-dose (day 1) to completion of visit 5 (Day 22)
For oral cohorts- t½,6856,SD: Terminal half-life of NNC0113-6856 after a single dose
Time Frame: From pre-dose (day 1) to completion of visit 5 (Day 22)
Measured in hours (h).
From pre-dose (day 1) to completion of visit 5 (Day 22)
For oral cohorts- AUC0-tz,4768,SD: Area under the NNC0113-4768 plasma concentration-time curve from time 0 to tz after a single dose, where tz is the time of last quantifiable concentration
Time Frame: From pre-dose (day 1) to completion of visit 5 (Day 22)
Measured in hours*nanomoles per liter (h*nmol/L).
From pre-dose (day 1) to completion of visit 5 (Day 22)
For oral cohorts- AUC0-∞,4768,SD: Area under the NNC0113-4768 plasma concentration-time curve from time 0 to infinity after a single dose
Time Frame: From pre-dose (day 1) to completion of visit 5 (Day 22)
Measured in hours*nanomoles per liter (h*nmol/L).
From pre-dose (day 1) to completion of visit 5 (Day 22)
For oral cohorts- Cmax,4768,SD: Maximum observed plasma concentration of NNC0113-4768 after a single dose
Time Frame: From pre-dose (day 1) to completion of visit 5 (Day 22)
Measured in nanomoles per liter (nmol/L).
From pre-dose (day 1) to completion of visit 5 (Day 22)
For oral cohorts- tmax,4768,SD: Time to maximum observed concentration of NNC0113-4768 after a single dose
Time Frame: From pre-dose (day 1) to completion of visit 5 (Day 22)
Measured in hours (h).
From pre-dose (day 1) to completion of visit 5 (Day 22)
For oral cohorts- t½,4768,SD: Terminal half-life of NNC0113-4768 after a single dose
Time Frame: From pre-dose (day 1) to completion of visit 5 (Day 22)
Measured in hours (h).
From pre-dose (day 1) to completion of visit 5 (Day 22)
For intravenous (i.v.) cohort- AUC0-infinity (∞),sema,SD: Area under the semaglutide plasma concentration-time curve from time 0 to infinity after a single dose
Time Frame: From pre-dose (day 1) to completion of follow-up visit (day 42)
Measured in hours*nanomoles per liter (h*nmol/L).
From pre-dose (day 1) to completion of follow-up visit (day 42)
For i.v. cohort- t½,sema,SD: Terminal half-life of semaglutide after a single dose
Time Frame: From pre-dose (day 1) to completion of follow-up visit (day 42)
Measured in hours (h).
From pre-dose (day 1) to completion of follow-up visit (day 42)
For i.v. cohort- Cmax,sema,SD: Maximum observed plasma concentration of semaglutide after a single dose
Time Frame: From pre-dose (day 1) to completion of follow-up visit (day 42)
Measured in nanomoles per liter (nmol/L).
From pre-dose (day 1) to completion of follow-up visit (day 42)
For i.v. cohort- AUC0-∞,6856,SD: Area under the NNC0113-6856 plasma concentration-time curve from time 0 to infinity after a single dose
Time Frame: From pre-dose (day 1) to completion of visit 5 (day 22)
Measured as hours*nanomoles per liter (h*nmol/L)
From pre-dose (day 1) to completion of visit 5 (day 22)
For i.v. cohort- t½,6856,SD: Terminal half-life of NNC0113-6856 after a single dose
Time Frame: From pre-dose (day 1) to completion of visit 5 (day 22)
Measured in hours (h).
From pre-dose (day 1) to completion of visit 5 (day 22)
For i.v. cohort- CL6856,SD: Total plasma clearance of NNC0113-6856 after a single dose
Time Frame: From pre-dose (day 1) to completion of visit 5 (Day 22)
Measured in liters per hour (L/h).
From pre-dose (day 1) to completion of visit 5 (Day 22)
For i.v. cohort- Vz6856,SD: Apparent volume of distribution of NNC0113-6856 after a single dose based on plasma concentration values
Time Frame: From pre-dose (day 1) to completion of visit 5 (Day 22)
Measured in liters (L).
From pre-dose (day 1) to completion of visit 5 (Day 22)
For i.v. cohort- MRT6856,SD: Mean residence time for NNC0113-6856 after a single dose
Time Frame: From pre-dose (day 1) to completion of visit 5 (Day 22)
Measured in hours (h).
From pre-dose (day 1) to completion of visit 5 (Day 22)
For i.v. cohort- AUC0-infinity (∞),4768,SD: Area under the NNC0113-4768 plasma concentration-time curve from time 0 to infinity after a single dose
Time Frame: From pre-dose (day 1) to completion of visit 5 (Day 22)
Measured in hours*nanomoles per liter (h*nmol/L).
From pre-dose (day 1) to completion of visit 5 (Day 22)
For i.v. cohort- t½,4768,SD: Terminal half-life of NNC0113-4768 after a single dose
Time Frame: From pre-dose (day 1) to completion of visit 5 (Day 22)
Measured in hours (h).
From pre-dose (day 1) to completion of visit 5 (Day 22)
For i.v. cohort and oral cohort- AUC0-∞,6856,SD/dose: Area under the NNC0113-6856 plasma concentration-time curve from 0 to infinity after a single dose divided by the dose administered
Time Frame: From pre-dose (day 1) to completion of visit 5 (Day 22)
Measured in hours*nanomoles per liter per milligram (h*nmol/L/mg).
From pre-dose (day 1) to completion of visit 5 (Day 22)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 26, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 27, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 27, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN9904-4825
  • U1111-1270-0813 (Other Identifier: World Health Organization (WHO))
  • 2021-005397-26 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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