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

Novo Nordisk A/S170 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

170

Conditions

Healthy Participants

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of adverse events (AEs)

Measured as number of events.

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

Secondary Outcomes

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

Measured in hours\*nanomoles per liter (h\*nmol/L).

Time frame: 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

Measured in nanomoles per liter(nmol/L).

Time frame: 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

Measured in h\*nmol/L.

Time frame: 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

Measured in nmol/L.

Time frame: 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

Measured in h\*nmol/L.

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

Part 1 (MAD): Cmax,4768,SS: maximum observed plasma concentration of NNC0113-4768 at steady state

Measured in nmol/L.

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

Part 2 Dosing condition (DC): AUCτ,sema,SS: area under the semaglutide plasma concentration-time curve during a dosing interval τ at steady state

Measured in h\*nmol/L.

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

Part 2 (DC): Cmax,sema,SS: maximum observed plasma concentration of semaglutide at steady state

Measured in nmol/L.

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

Part 2 (DC): AUCτ,6856,SS: area under the NNC0113-6856 plasma concentration-time curve during a dosing interval τ at steady state

Measured in h\*nmol/L.

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

Part 2 (DC): Cmax,6856,SS: maximum observed plasma concentration of NNC0113-6856 at steady state

Measured in nmol/L.

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

Part 2 (DC): AUCτ,4768,SS: area under the NNC0113-4768 plasma concentration-time curve during a dosing interval τ at steady state

Measured in h\*nmol/L.

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

Part 2 (DC): Cmax,4768,SS: maximum observed plasma concentration of NNC0113-4768 at steady state

Measured in nmol/L.

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

Part 3 Japanese (JP): AUCτ,sema,SS: area under the semaglutide plasma concentration-time curve during a dosing interval τ at steady state

Measured in h\*nmol/L.

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

Part 3 (JP): Cmax,sema,SS: maximum observed plasma concentration of semaglutide at steady state

Measured in nmol/L.

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

Part 3 (JP): AUCτ,6856,SS: area under the NNC0113-6856 plasma concentration-time curve during a dosing interval τ at steady state

Measured in h\*nmol/L.

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

Part 3 (JP): Cmax,6856,SS: maximum observed plasma concentration of NNC0113-6856 at steady state

Measured in nmol/L.

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

Part 3 (JP): AUCτ,4768,SS: area under the NNC0113-4768 plasma concentration-time curve during a dosing interval τ at steady state

Measured in h\*nmol/L.

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

Part 3 (JP): Cmax,4768,SS: maximum observed plasma concentration of NNC0113-4768 at steady state

Measured in nmol/L.

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes