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

Non-alcoholic Steatohepatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05766709
• Other study ID #: NN9500-4932
• Secondary ID: U1111-1285-5065
• Status: Completed
• Phase: Phase 1
• Start date: March 2, 2023
• Est. completion date: February 9, 2024

Study information

• Verified date: February 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: February 9, 2024
• Est. primary completion date: January 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Non-alcoholic Steatohepatitis

Intervention

Drug:
• NNC0194-0499
NNC0194-0499 will be administered subcutaneously once weekly.
• Semaglutide
Semaglutide will be administered subcutaneously once weekly.
• NNC0194-0499/Semaglutide A (40/3.20 mg/mL)
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)
NNC0194-0499/Semaglutide A (40/0.33mg/mL) will be administered subcutaneously once weekly.

Locations

Country	Name	City	State
Canada	Altasciences Company Inc.	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Measured as nanomoles*hours per liter (nmol*h/L)	Day 134 (pre-dose) to Day 141 (168 hours post-dose)
Primary	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	Measured as nmol*h/L	Day 134 (pre-dose) to Day 141 (168 hours post-dose)
Primary	Cmax, 0499, SS: Maximum concentration of NNC0194-0499 at steady state after dosing of NNC0194-0499 in combination with semaglutide	Measured as nanomoles per liter (nmol/L)	Day 134 (pre-dose) to Day 141 (168 hours post-dose)
Primary	Cmax,sema, SS: Maximum concentration of semaglutide at steady state after dosing of NNC0194-0499 in combination with semaglutide	Measured as nmol/L	Day 134 (pre-dose) to Day 141 (168 hours post-dose)
Secondary	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	Measured as nmol*h/L	Day 22 (pre-dose) to Day 29 (168 hours post-dose)
Secondary	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	Measured as nmol*h/L	Day 22 (pre-dose) to Day 29 (168 hours post-dose)
Secondary	Cmax, 0499, SS: Maximum concentration of NNC0194-0499 at steady state after dosing of NNC0194-0499 in combination with semaglutide	Measured as nmol/L	Day 22 (pre-dose) to Day 29 (168 hours post-dose)
Secondary	Cmax, sema , SS: Maximum concentration of semaglutide at steady state after dosing of semaglutide in combination with NNC0194-0499	Measured as nmol/L	Day 22 (pre-dose) to Day 29 (168 hours post-dose)
Secondary	Number of treatment emergent adverse events	Measured as count of events	Day 1 (post-dose) to Day 197 (Groups 1 and 2) and Day 1 (post-dose) to Day 57 (Group 3)