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

NCT06069895 | Completed Phase 1

• 2 other identifiers: NN9904-5008U1111-1284-5743
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

• Number of adverse events (AEs)

  Measured as number of events.

  From time of first dosing (day 1) until completion of the follow-up visit (day 148)

Secondary Outcomes (18)

• 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

  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

  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

  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

  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

  From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106

Study Arms (2)

NNC0113-6856

EXPERIMENTAL

Participants will receive NNC0113-6856 oral tablets.

Drug: NNC0113-6856

Placebo

EXPERIMENTAL

Participants will receive NNC0113-6856 matching placebo oral tablets.

Drug: Placebo

Interventions

NNC0113-6856 DRUG

NNC0113-6856 will be administered as oral tablets.

NNC0113-6856

Placebo DRUG

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

Placebo

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• HbA1c greater than or equal to (≥) 6.5 percent (%) (48 millimoles per mole \[mmol/mol\]) at screening.
• Alanine Aminotransferase (ALT) greater than (\>) upper normal limit (UNL) +10%
• Aspartate aminotransferase (AST) \> UNL+20%
• Total bilirubin \> UNL+20%
• Creatinine \> UNL+10%
• International normalised ratio (INR) \> UNL

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

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: September 29, 2023
• First Posted: October 6, 2023
• Study Start: October 4, 2023
• Primary Completion: April 23, 2025
• Study Completion: April 23, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)