NNC0194-0499 + Semaglutide for Fatty Liver Disease

Recruiting in Palo Alto (17 mi)

+404 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Novo Nordisk A/S

Prior Safety Data

Trial Summary

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.

Research Team

Clinical Transparency (dept. 1452)

Principal Investigator

Novo Nordisk A/S

Eligibility Criteria

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.

Treatment Details

Interventions

• NNC0174 0833 10 mg/mL (Other)
• NNC0174 0833 placebo (Other)
• NNC0194 0499 50 mg/mL (Other)
• Placebo (NNC0194-0499) (Other)
• Semaglutide (GLP-1 Receptor Agonist)
• Semaglutide placebo (GLP-1 Receptor Agonist)

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.

Participant Groups

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Digestive Hlth Res of SoCa Long Beach, CA

AIG Digestive Disease Research Florham Park, NJ

NYU Grossman School of Med New York, NY

Texas Clin Res Inst, LLC Arlington, TX

More Trial Locations

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1578

Patients Recruited

3,813,000+