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

NCT ID: NCT05766709

Last Updated: 2024-02-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-02
• Study Completion Date: 2024-02-09

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.

Conditions

Non-alcoholic Steatohepatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

NNC0194-0499

Intervention Type: DRUG

NNC0194-0499 will be administered subcutaneously once weekly.

Semaglutide

Intervention Type: DRUG

Semaglutide will be administered subcutaneously once weekly.

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

Intervention Type: DRUG

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

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).

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Interventions

NNC0194-0499

NNC0194-0499 will be administered subcutaneously once weekly.

Intervention Type: DRUG

Semaglutide

Semaglutide will be administered subcutaneously once weekly.

Intervention Type: 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.

Intervention Type: DRUG

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

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

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency dept.2834

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Altasciences Company Inc.

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

U1111-1285-5065

Identifier Type: OTHER

Identifier Source: secondary_id

NN9500-4932

Identifier Type: -

Identifier Source: org_study_id