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
CT
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.
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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.
See 5 more
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 OverviewThe 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
10Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: NNC0194-0499 7.5 mg + semaglutide 2.4 mgExperimental Treatment2 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 mgExperimental Treatment2 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 mgExperimental Treatment1 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 mgExperimental Treatment2 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 mgExperimental Treatment2 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 mgActive Control2 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 mgPlacebo Group2 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 mgPlacebo Group2 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 mgPlacebo Group2 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 mgPlacebo Group2 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 NearbySelect from list below to view details:
Digestive Hlth Res of SoCaLong Beach, CA
AIG Digestive Disease ResearchFlorham Park, NJ
NYU Grossman School of MedNew York, NY
Texas Clin Res Inst, LLCArlington, TX
More Trial Locations
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Who Is Running the Clinical Trial?
Novo Nordisk A/S
Lead Sponsor
Trials
1578
Patients Recruited
3,813,000+