Back to resultsA Research Study Comparing Blood Levels of Medicines NNC0194-0499 and Semaglutide Administered as a Combination Formulation Versus Two Separate Formulations
Primary Purpose
Non-alcoholic Steatohepatitis
Status
Recruiting
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
NNC0194-0499
Semaglutide
NNC0194-0499/Semaglutide A (40/3.20 mg/mL)
NNC0194-0499/Semaglutide A (40/0.33mg/mL)
Sponsored by
About this trial
This is an interventional treatment trial for Non-alcoholic Steatohepatitis
Eligibility Criteria
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)
Sites / Locations
- Novo Nordisk Investigational SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group 1
Group 2
Group 3
Arm Description
Participants will receive separate injections of NNC0194-0499 B and Semaglutide B for 24 weeks. Dose escalation manner every 4 weeks for 20 weeks (30 mg NNC0194-0499 B and 0.24 mg Semaglutide B for Weeks 1-4, 30 mg NNC0194-0499 B and 0.5 mg Semaglutide B for Weeks 5-8, 30 mg NNC0194-0499 B and 1.0 mg Semaglutide B for Weeks 9-12, 30 mg NNC0194-0499 B and 1.7 mg Semaglutide B for Weeks 13-16 and 30 mg NNC0194-0499 B and 2.4 mg Semaglutide B for Weeks 17-20). Participants will receive NNC0194-0499/Semaglutide A 40/3.20 mg/mL co-formulation at the target dose of 30/2.4 mg during the weeks 21-24 (maintenance dosing period).
Participants will receive NNC0194-0499/Semaglutide A 40/3.20 mg/mL co-formulation for 24 weeks. Dose escalation manner every 4 weeks for 20 weeks (3.1mg/0.25mg for Weeks 1-4, 6.3mg/0.5mg for Weeks 5-8, 12.5mg/1.0mg for Weeks 9-12, 21.3mg/1.7mg for Weeks 13-16 and 30mg/2.4mg for weeks 17-20). Participants will receive NNC0194-0499/Semaglutide 40/3.20 mg/mL co-formulation at the target dose of 30mg/2.4mg during the weeks 21-24 (maintenance dosing period).
Participants will receive 4 weekly injections of NNC0194-0499/Semaglutide A 40/0.33 mg/mL co-formulation at the dose level of 30mg/0.25 mg.
Outcomes
Primary Outcome Measures
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)
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
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)
Cmax,sema, SS: Maximum concentration of semaglutide at steady state after dosing of NNC0194-0499 in combination with semaglutide
Measured as nmol/L
Secondary Outcome Measures
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
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
Cmax, 0499, SS: Maximum concentration of NNC0194-0499 at steady state after dosing of NNC0194-0499 in combination with semaglutide
Measured as nmol/L
Cmax, sema , SS: Maximum concentration of semaglutide at steady state after dosing of semaglutide in combination with NNC0194-0499
Measured as nmol/L
Number of treatment emergent adverse events
Measured as count of events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05766709
Brief Title
A Research Study Comparing Blood Levels of Medicines NNC0194-0499 and Semaglutide Administered as a Combination Formulation Versus Two Separate Formulations
Official Title
Investigation of Pharmacokinetics Following Administration of NNC0194-0499 and Semaglutide as Co-formulation Versus Separate Injections in Healthy Participants
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2023 (Actual)
Primary Completion Date
November 8, 2023 (Anticipated)
Study Completion Date
November 8, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Steatohepatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Participants will receive separate injections of NNC0194-0499 B and Semaglutide B for 24 weeks. Dose escalation manner every 4 weeks for 20 weeks (30 mg NNC0194-0499 B and 0.24 mg Semaglutide B for Weeks 1-4, 30 mg NNC0194-0499 B and 0.5 mg Semaglutide B for Weeks 5-8, 30 mg NNC0194-0499 B and 1.0 mg Semaglutide B for Weeks 9-12, 30 mg NNC0194-0499 B and 1.7 mg Semaglutide B for Weeks 13-16 and 30 mg NNC0194-0499 B and 2.4 mg Semaglutide B for Weeks 17-20). Participants will receive NNC0194-0499/Semaglutide A 40/3.20 mg/mL co-formulation at the target dose of 30/2.4 mg during the weeks 21-24 (maintenance dosing period).
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Participants will receive NNC0194-0499/Semaglutide A 40/3.20 mg/mL co-formulation for 24 weeks. Dose escalation manner every 4 weeks for 20 weeks (3.1mg/0.25mg for Weeks 1-4, 6.3mg/0.5mg for Weeks 5-8, 12.5mg/1.0mg for Weeks 9-12, 21.3mg/1.7mg for Weeks 13-16 and 30mg/2.4mg for weeks 17-20). Participants will receive NNC0194-0499/Semaglutide 40/3.20 mg/mL co-formulation at the target dose of 30mg/2.4mg during the weeks 21-24 (maintenance dosing period).
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Participants will receive 4 weekly injections of NNC0194-0499/Semaglutide A 40/0.33 mg/mL co-formulation at the dose level of 30mg/0.25 mg.
Intervention Type
Drug
Intervention Name(s)
NNC0194-0499
Intervention Description
NNC0194-0499 will be administered subcutaneously once weekly.
Intervention Type
Drug
Intervention Name(s)
Semaglutide
Intervention Description
Semaglutide will be administered subcutaneously once weekly.
Intervention Type
Drug
Intervention Name(s)
NNC0194-0499/Semaglutide A (40/3.20 mg/mL)
Intervention Description
NNC0194-0499/Semaglutide A (40/3.20 mg/mL) co-formulation product will be administered subcutaneously once weekly.
Intervention Type
Drug
Intervention Name(s)
NNC0194-0499/Semaglutide A (40/0.33mg/mL)
Intervention Description
NNC0194-0499/Semaglutide A (40/0.33mg/mL) will be administered subcutaneously once weekly.
Primary Outcome Measure Information:
Title
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
Description
Measured as nanomoles*hours per liter (nmol*h/L)
Time Frame
Day 134 (pre-dose) to Day 141 (168 hours post-dose)
Title
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
Description
Measured as nmol*h/L
Time Frame
Day 134 (pre-dose) to Day 141 (168 hours post-dose)
Title
Cmax, 0499, SS: Maximum concentration of NNC0194-0499 at steady state after dosing of NNC0194-0499 in combination with semaglutide
Description
Measured as nanomoles per liter (nmol/L)
Time Frame
Day 134 (pre-dose) to Day 141 (168 hours post-dose)
Title
Cmax,sema, SS: Maximum concentration of semaglutide at steady state after dosing of NNC0194-0499 in combination with semaglutide
Description
Measured as nmol/L
Time Frame
Day 134 (pre-dose) to Day 141 (168 hours post-dose)
Secondary Outcome Measure Information:
Title
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
Description
Measured as nmol*h/L
Time Frame
Day 22 (pre-dose) to Day 29 (168 hours post-dose)
Title
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
Description
Measured as nmol*h/L
Time Frame
Day 22 (pre-dose) to Day 29 (168 hours post-dose)
Title
Cmax, 0499, SS: Maximum concentration of NNC0194-0499 at steady state after dosing of NNC0194-0499 in combination with semaglutide
Description
Measured as nmol/L
Time Frame
Day 22 (pre-dose) to Day 29 (168 hours post-dose)
Title
Cmax, sema , SS: Maximum concentration of semaglutide at steady state after dosing of semaglutide in combination with NNC0194-0499
Description
Measured as nmol/L
Time Frame
Day 22 (pre-dose) to Day 29 (168 hours post-dose)
Title
Number of treatment emergent adverse events
Description
Measured as count of events
Time Frame
Day 1 (post-dose) to Day 197 (Groups 1 and 2) and Day 1 (post-dose) to Day 57 (Group 3)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novo Nordisk
Phone
(+1) 866-867-7178
Email
clinicaltrials@novonordisk.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Transparency dept.2834
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3P 3P1
Country
Canada
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
IPD Sharing URL
http://novonordisk-trials.com
Learn more about this trial
A Research Study Comparing Blood Levels of Medicines NNC0194-0499 and Semaglutide Administered as a Combination Formulation Versus Two Separate Formulations
We'll reach out to this number within 24 hrs