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

NCT ID: NCT05521256

Last Updated: 2025-12-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-26
• Study Completion Date: 2023-03-27

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

NNC0113-6856 (i.v. Cohort)

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

Group Type: EXPERIMENTAL

NNC0113-6856

Intervention Type: DRUG

Participants will receive NN0113-6856 orally or intravenously.

NNC0113-6856 (Oral Cohort)

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

Group Type: EXPERIMENTAL

NNC0113-6856

Intervention Type: DRUG

Participants will receive NN0113-6856 orally or intravenously.

Interventions

NNC0113-6856

Participants will receive NN0113-6856 orally or intravenously.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency dept. 2834

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Profil Institut für Stoffwechselforschung GmbH

Neuss, North Rhine-Westphalia, Germany

Profil GmbH & Co. KG

Mainz, , Germany

Profil Institut für Stoffwechselforschung GmbH

Neuss, , Germany

Countries

Germany

Other Identifiers

U1111-1270-0813

Identifier Type: OTHER

Identifier Source: secondary_id

2021-005397-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN9904-4825

Identifier Type: -

Identifier Source: org_study_id