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Completed

NCT Number: NCT05766709

A Research Study Comparing Blood Levels of Medicines NNC0194-0499 and Semaglutide Administered as a Combination Formulation Versus Two Separate Formulations

Novo Nordisk is developing a combination of 2 medicines (NNC0194-0499 and semaglutide) for the treatment of nonalcoholic steatohepatitis (NASH). NASH is a serious disease where fat, inflammation and scar tissue builds up in the liver. NNC0194-0499 is a new medicine which works in the liver. Semaglutide is a well-known medicine, which is already used to treat type 2 diabetes and obesity. The study is being done to see how 2 medicines (NNC0194-0499 and semaglutide) are absorbed, transported, and eliminated from the body in a combination formulation. Participants will either get NNC0194-0499 and semaglutide in a combination formulation or the separate formulations. Which treatment participants get is decided by chance. The study will last for either 13 or 33 weeks. The duration is decided by chance.

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Key information

Conditions

Non-alcoholic Steatohepatitis Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences Company Inc.

Montreal, Quebec, H3P 3P1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female
  • Aged 18-55 years (both inclusive) at the time of signing informed consent
  • Body mass index (BMI) between greater than or equal to 25 and less than or equal to 35 kilogram per meter square (kg/m^2) (both inclusive)
  • Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion criteria

  • Known or suspected hypersensitivity to study intervention(s) or related products
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method
  • Participation (that is, signed informed consent) in any other interventional clinical study within 90 days before first trial product administration (Visit 2, Day 1)
  • Use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medication, highly effective contraceptives and occasional use of paracetamol, acetylsalicylic acid within 14 days before first trial product administration (Visit 2, Day 1)

Treatment and study plan

NNC0194-0499

Drug

NNC0194-0499 will be administered subcutaneously once weekly.

semaglutide

Drug

Semaglutide will be administered subcutaneously once weekly.

NNC0194-0499/Semaglutide A (40/3.20 mg/mL)

Drug

NNC0194-0499/Semaglutide A (40/3.20 mg/mL) co-formulation product will be administered subcutaneously once weekly.

NNC0194-0499/Semaglutide A (40/0.33mg/mL)

Drug

NNC0194-0499/Semaglutide A (40/0.33mg/mL) will be administered subcutaneously once weekly.

Primary outcomes

  1. AUC 0-168 hour (h), 0499, steady state (SS): Area under the NNC0194-0499 concentration time curve during a dosing interval (0-168 hours) at steady state after dosing of NNC0194-0499 in combination with semaglutide

    Time frame: Day 134 (pre-dose) to Day 141 (168 hours post-dose)

    Measured as nanomoles*hours per liter (nmol*h/L)

  2. AUC 0-168h,sema,SS: Area under the semaglutide concentration time curve during a dosing interval (0-168 hours) at steady state after dosing of NNC0194-0499 in combination with semaglutide

    Time frame: Day 134 (pre-dose) to Day 141 (168 hours post-dose)

    Measured as nmol*h/L

  3. Cmax, 0499, SS: Maximum concentration of NNC0194-0499 at steady state after dosing of NNC0194-0499 in combination with semaglutide

    Time frame: Day 134 (pre-dose) to Day 141 (168 hours post-dose)

    Measured as nanomoles per liter (nmol/L)

  4. Cmax,sema, SS: Maximum concentration of semaglutide at steady state after dosing of NNC0194-0499 in combination with semaglutide

    Time frame: Day 134 (pre-dose) to Day 141 (168 hours post-dose)

    Measured as nmol/L

Secondary outcomes

  1. AUC 0-168h, 0499, SS: Area under the NNC0194-0499 concentration-time curve during a dosing interval (0-168 hours) at steady state after dosing of NNC0194-0499 in combination with semaglutide

    Time frame: Day 22 (pre-dose) to Day 29 (168 hours post-dose)

    Measured as nmol*h/L

  2. AUC 0-168h, sema , SS: Area under the semaglutide concentration-time curve during a dosing interval (0-168 hours) at steady state after dosing of semaglutide in combination with NNC0194-0499

    Time frame: Day 22 (pre-dose) to Day 29 (168 hours post-dose)

    Measured as nmol*h/L

  3. Cmax, 0499, SS: Maximum concentration of NNC0194-0499 at steady state after dosing of NNC0194-0499 in combination with semaglutide

    Time frame: Day 22 (pre-dose) to Day 29 (168 hours post-dose)

    Measured as nmol/L

  4. Cmax, sema , SS: Maximum concentration of semaglutide at steady state after dosing of semaglutide in combination with NNC0194-0499

    Time frame: Day 22 (pre-dose) to Day 29 (168 hours post-dose)

    Measured as nmol/L

  5. Number of treatment emergent adverse events

    Time frame: Day 1 (post-dose) to Day 197 (Groups 1 and 2) and Day 1 (post-dose) to Day 57 (Group 3)

    Measured as count of events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Investigation of Pharmacokinetics Following Administration of NNC0194-0499 and Semaglutide as Co-formulation Versus Separate Injections in Healthy Participants

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 13, 2023
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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