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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: NNC0113-6856; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06069895

NN9904-5008

U1111-1284-5743 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 170 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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170 participants in 2 patient groups

NNC0113-6856

Experimental group

Description:

Participants will receive NNC0113-6856 oral tablets.

Treatment:

Drug: NNC0113-6856

Placebo

Experimental group

Description:

Participants will receive NNC0113-6856 matching placebo oral tablets.

Treatment:

Drug: Placebo