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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-04

Study Completion Date

2025-04-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NNC0113-6856

Participants will receive NNC0113-6856 oral tablets.

Group Type EXPERIMENTAL

NNC0113-6856

Intervention Type DRUG

NNC0113-6856 will be administered as oral tablets.

Placebo

Participants will receive NNC0113-6856 matching placebo oral tablets.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

NNC0113-6856 matching placebo will be administered as oral tablets.

Interventions

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NNC0113-6856

NNC0113-6856 will be administered as oral tablets.

Intervention Type DRUG

Placebo

NNC0113-6856 matching placebo will be administered as oral tablets.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes