Investigation of Safety, Tolerability and Pharmacokinetics of Multiple Doses of NNC0113-6856 in Healthy Participants, Including a Subset of Healthy Japanese Participants

June 17, 2025 updated by: Novo Nordisk A/S
NNC0113-6856 is a new medicine which may help participants with type 2 diabetes to improve blood sugar control. NNC0113-6856 is slowly converted in the body to semaglutide, a substance similar to a hormone (signaling substance) in the body. The main purpose of this study will be to evaluate the safety of different strengths of NNC0113-6856 when given as multiple administrations, and the amount of NNC0113-6856 in the blood will be measured as well as the amount of specific parts (including semaglutide). Participants will either get multiple doses of the new medicine NNC0113-6856 or multiple doses of placebo (a "dummy" medicine that looks like the new medicine but is without any active ingredient). Whether participants get the new medicine or placebo is decided by chance. The duration of the study could last up to 25 weeks.

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.
170

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Neuss, 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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male or female.
  • Age 18-55 years (both inclusive) at the time of signing the informed consent.
  • Body mass index (BMI) between 21.0 and 29.9 kilograms per meter square (kg/m^2) (both inclusive) at screening.

Additional for healthy Japanese participants:

  • First generation Japanese (Japanese born participants).

Exclusion Criteria:

  • HbA1c greater than or equal to (≥) 6.5 percent (%) (48 millimoles per mole [mmol/mol]) at screening.

  • 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:

    1. Alanine Aminotransferase (ALT) greater than (>) upper normal limit (UNL) +10%
    2. Aspartate aminotransferase (AST) > UNL+20%
    3. Total bilirubin > UNL+20%
    4. Creatinine > UNL+10%
    5. International normalised ratio (INR) > UNL

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
Participants will receive NNC0113-6856 oral tablets.
Drug: NNC0113-6856
NNC0113-6856 will be administered as oral tablets.
Experimental: Placebo
Participants will receive NNC0113-6856 matching placebo oral tablets.
Drug: Placebo
NNC0113-6856 matching placebo will be administered as oral tablets.

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 (AEs)
Time Frame: From time of first dosing (day 1) until completion of the follow-up visit (day 148)
Measured as number of events.
From time of first dosing (day 1) until completion of the follow-up visit (day 148)

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
Part 1 Multiple ascending dose (MAD): AUCτ,sema,SS: area under the semaglutide plasma concentration-time curve during a dosing interval τ at steady state
Time Frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Measured in hours*nanomoles per liter (h*nmol/L).
From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 1 (MAD): Cmax,sema,SS: maximum observed plasma concentration of semaglutide at steady state
Time Frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Measured in nanomoles per liter(nmol/L).
From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 1 (MAD): AUCτ,6856,SS: area under the NNC0113-6856 plasma concentration-time curve during a dosing interval τ at steady state
Time Frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Measured in h*nmol/L.
From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 1 (MAD): Cmax,6856,SS: maximum observed plasma concentration of NNC0113-6856 at steady state
Time Frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Measured in nmol/L.
From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 1 (MAD): AUCτ,4768,SS: area under the NNC0113-4768 plasma concentration-time curve during a dosing interval τ at steady state
Time Frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Measured in h*nmol/L.
From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 1 (MAD): Cmax,4768,SS: maximum observed plasma concentration of NNC0113-4768 at steady state
Time Frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Measured in nmol/L.
From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 2 Dosing condition (DC): AUCτ,sema,SS: area under the semaglutide plasma concentration-time curve during a dosing interval τ at steady state
Time Frame: From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106
Measured in h*nmol/L.
From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106
Part 2 (DC): Cmax,sema,SS: maximum observed plasma concentration of semaglutide at steady state
Time Frame: From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106
Measured in nmol/L.
From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106
Part 2 (DC): AUCτ,6856,SS: area under the NNC0113-6856 plasma concentration-time curve during a dosing interval τ at steady state
Time Frame: From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106
Measured in h*nmol/L.
From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106
Part 2 (DC): Cmax,6856,SS: maximum observed plasma concentration of NNC0113-6856 at steady state
Time Frame: From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106
Measured in nmol/L.
From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106
Part 2 (DC): AUCτ,4768,SS: area under the NNC0113-4768 plasma concentration-time curve during a dosing interval τ at steady state
Time Frame: From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106
Measured in h*nmol/L.
From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106
Part 2 (DC): Cmax,4768,SS: maximum observed plasma concentration of NNC0113-4768 at steady state
Time Frame: From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106
Measured in nmol/L.
From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106
Part 3 Japanese (JP): AUCτ,sema,SS: area under the semaglutide plasma concentration-time curve during a dosing interval τ at steady state
Time Frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Measured in h*nmol/L.
From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 3 (JP): Cmax,sema,SS: maximum observed plasma concentration of semaglutide at steady state
Time Frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Measured in nmol/L.
From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 3 (JP): AUCτ,6856,SS: area under the NNC0113-6856 plasma concentration-time curve during a dosing interval τ at steady state
Time Frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Measured in h*nmol/L.
From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 3 (JP): Cmax,6856,SS: maximum observed plasma concentration of NNC0113-6856 at steady state
Time Frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Measured in nmol/L.
From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 3 (JP): AUCτ,4768,SS: area under the NNC0113-4768 plasma concentration-time curve during a dosing interval τ at steady state
Time Frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Measured in h*nmol/L.
From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 3 (JP): Cmax,4768,SS: maximum observed plasma concentration of NNC0113-4768 at steady state
Time Frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Measured in nmol/L.
From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106

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.
October 4, 2023

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.
April 23, 2025

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.
April 23, 2025

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).
September 29, 2023

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.
September 29, 2023

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.
October 6, 2023

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.
June 18, 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.
June 17, 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.
June 1, 2025

More Information

Terms related to this study

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.
  • NN9904-5008
  • U1111-1284-5743 (Other Identifier: World Health Organization (WHO))

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

No

Studies a U.S. FDA-regulated device product

No

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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