NNC0194-0499 + Semaglutide for Fatty Liver Disease

Recruiting at 406 trial locations

Overseen By Novo Nordisk

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Novo Nordisk A/S

Must not be taking: Vitamin E, Pioglitazone, GLP-1 RAs

Disqualifiers: Chronic liver disease, HIV, HCV, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 14

Duration: 52 weeks

698 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing if combining two medicines, NNC0194-0499 and semaglutide, can reduce liver damage in people with non-alcoholic steatohepatitis (NASH). Semaglutide, already used for diabetes and weight loss, and NNC0194-0499 work differently but may be more effective together. Another combination being tested includes semaglutide and NNC0174-0833. Participants will receive regular injections and undergo liver biopsies to measure the treatment's effectiveness.

Who Is on the Research Team?

Clinical Transparency (dept. 1452)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

Adults with a certain liver condition called NASH and evidence of liver scarring (fibrosis stages 2-4) can join this study. They must have had a recent biopsy confirming the disease. Pregnant women or those planning pregnancy, heavy drinkers, and people on unstable doses of certain medications are excluded.

Inclusion Criteria

My liver biopsy confirms I have NASH.

My liver disease score is high enough to meet the trial's requirements.

I am of legal age in my country to consent to participate in a clinical trial.

Exclusion Criteria

I have had serious liver problems or a liver transplant.

I haven't taken GLP-1 receptor agonists in the last 90 days.

My diabetes, cholesterol, or weight loss medication doses have been stable for the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly injections of either two active drugs, one active drug and one placebo, or two placebo injections for 52 weeks

52 weeks

14 clinic visits, 9 phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NNC0174 0833 10 mg/mL
• NNC0174 0833 placebo
• NNC0194 0499 50 mg/mL
• Placebo (NNC0194-0499)
• Semaglutide
• Semaglutide placebo

Trial Overview The trial is testing if two drugs, NNC0194-0499 and semaglutide, can help reduce liver damage in NASH patients when used together or separately compared to placebo injections. Participants will receive weekly injections for about 19 months with regular clinic visits and calls.

How Is the Trial Designed?

Group I: NNC0194-0499 7.5 mg + semaglutide 2.4 mg Experimental Treatment 2 Interventions

Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.

Group II: NNC0194-0499 30 mg + semaglutide placebo 2.4 mg Experimental Treatment 2 Interventions

Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.

Group III: NNC0194-0499 30 mg + semaglutide 2.4 mg Experimental Treatment 1 Intervention

Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.

Group IV: NNC0194-0499 15 mg + semaglutide 2.4 mg Experimental Treatment 2 Interventions

Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.

Group V: NNC0174-0833 2.4 mg + semaglutide 2.4 mg Experimental Treatment 2 Interventions

Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.

Group VI: Placebo (NNC0194-0499) 30 mg + semaglutide 2.4 mg Active Control 2 Interventions

Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.

Group VII: Placebo (NNC0194-0499) 7.5 mg + semaglutide placebo 2.4 mg Placebo Group 2 Interventions

Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.

Group VIII: Placebo (NNC0194-0499) 15 mg + semaglutide placebo 2.4 mg Placebo Group 2 Interventions

Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.

Group IX: Placebo (NNC0194-0499) 30 mg + semaglutide placebo 2.4 mg Placebo Group 2 Interventions

Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.

Group X: Placebo (NNC0174-0833) 2.4 mg + semaglutide placebo 2.4 mg Placebo Group 2 Interventions

Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1,578

Recruited

3,813,000+

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen