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

NCT05521256 | Completed Phase 1 FDA Drug

• 3 other identifiers: NN9904-4825U1111-1270-08132021-005397-26
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Healthy Volunteers; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (26)

• 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

  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

  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

  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

  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

  From pre-dose (day 1) to completion of follow-up visit (day 42)

Study Arms (3)

NNC0113-6856 (Oral Cohort)

EXPERIMENTAL

Participants will receive single oral dose of NNC0113-6856 tablets in dose escalated manner.

Drug: NNC0113-6856

Placebo

PLACEBO COMPARATOR

Participants will receive single oral dose of placebo (NNC0113-6856) tablets in dose escalated manner.

Drug: Placebo

NNC0113-6856 (i.v. Cohort)

EXPERIMENTAL

Participants will receive single dose of 1.5 milligrams (mg) NNC0113-6856 intravenously (i.v.).

Drug: NNC0113-6856

Interventions

Placebo DRUG

Participants will receive matching placebo of NNC0113-6856 for each of the oral cohorts.

Placebo

NNC0113-6856 DRUG

Participants will receive NN0113-6856 orally or intravenously.

NNC0113-6856 (Oral Cohort); NNC0113-6856 (i.v. Cohort)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (3)

Profil Institut für Stoffwechselforschung GmbH

Neuss, North Rhine-Westphalia, 41460, Germany

Location

Profil GmbH & Co. KG

Mainz, 55116, Germany

Location

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2022
• First Posted: August 30, 2022
• Study Start: August 26, 2022
• Primary Completion: March 27, 2023
• Study Completion: March 27, 2023
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

DE (3)