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

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: Completed
• Conditions: Type 2 Diabetes; Healthy Volunteers
• Intervention / Treatment: Drug: NNC0113-6856; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 1

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Number of adverse events	Measured as number of events.	From time of dosing (day 1) until completion of the follow-up visit (Day 42)

Secondary Outcome Measures

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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2022
• Primary Completion (Actual): March 27, 2023
• Study Completion (Actual): March 27, 2023

Study Registration Dates

• First Submitted: August 27, 2022
• First Submitted That Met QC Criteria: August 27, 2022
• First Posted (Actual): August 30, 2022

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID 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