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

January 7, 2024 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

170

Phase

  • 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 Locations

  • Germany
      • Neuss, Germany, 41460
        • Recruiting
        • Novo Nordisk Investigational Site

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

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
Intervention / Treatment
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

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

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

Novo Nordisk A/S

Investigators

  • 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)

October 4, 2023

Primary Completion (Estimated)

June 6, 2025

Study Completion (Estimated)

June 6, 2025

Study Registration Dates

First Submitted

September 29, 2023

First Submitted That Met QC Criteria

September 29, 2023

First Posted (Actual)

October 6, 2023

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 7, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID 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.

Clinical Trials on Healthy Participants

Clinical Trials on NNC0113-6856

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe