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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05766709

Collaborator

(none)

Enrollment

Location

Arms

8.3

Anticipated Duration (Months)

5.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Non-alcoholic Steatohepatitis	Drug: NNC0194-0499 Drug: Semaglutide Drug: NNC0194-0499/Semaglutide A (40/3.20 mg/mL) Drug: NNC0194-0499/Semaglutide A (40/0.33mg/mL)	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 28, 2023

Anticipated Primary Completion Date :

Nov 8, 2023

Anticipated Study Completion Date :

Nov 8, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 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).	Drug: NNC0194-0499 NNC0194-0499 will be administered subcutaneously once weekly. Drug: Semaglutide Semaglutide will be administered subcutaneously once weekly. Drug: 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.
Experimental: Group 2 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).	Drug: 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.
Experimental: Group 3 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.	Drug: NNC0194-0499/Semaglutide A (40/0.33mg/mL) NNC0194-0499/Semaglutide A (40/0.33mg/mL) will be administered subcutaneously once weekly.

Arm

Intervention/Treatment

Experimental: Group 1

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).

Drug: NNC0194-0499

NNC0194-0499 will be administered subcutaneously once weekly.

Drug: Semaglutide

Semaglutide will be administered subcutaneously once weekly.

Drug: 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.

Experimental: Group 2

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).

Drug: 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.

Experimental: Group 3

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.

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

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

Outcome Measures

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 [Day 134 (pre-dose) to Day 141 (168 hours post-dose)]
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 [Day 134 (pre-dose) to Day 141 (168 hours post-dose)]
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 [Day 134 (pre-dose) to Day 141 (168 hours post-dose)]
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 [Day 134 (pre-dose) to Day 141 (168 hours post-dose)]
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 [Day 22 (pre-dose) to Day 29 (168 hours post-dose)]
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 [Day 22 (pre-dose) to Day 29 (168 hours post-dose)]
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 [Day 22 (pre-dose) to Day 29 (168 hours post-dose)]
Measured as nmol/L
Cmax, sema , SS: Maximum concentration of semaglutide at steady state after dosing of semaglutide in combination with NNC0194-0499 [Day 22 (pre-dose) to Day 29 (168 hours post-dose)]
Measured as nmol/L
Number of treatment emergent adverse events [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Montreal	Quebec	Canada	H3P 3P1

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director: Clinical Transparency dept.2834, Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT05766709

Other Study ID Numbers:

NN9500-4932
U1111-1285-5065

First Posted:

Mar 13, 2023

Last Update Posted:

Mar 13, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Fatty Liver

Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Mar 13, 2023