Research Study on Whether a Combination of 2 Medicines (NNC0194 0499 and Semaglutide) Works in People With Non-alcoholic Steatohepatitis (NASH)

Conditions

• Non-alcoholic Steatohepatitis

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• NNC0194 0499 50 mg/mL — DRUG
  Patients will receive subcutaneous (s.c., under the skin) injections of NNC0194-0499 once weekly The study will last for about 19 months
• Placebo (NNC0194-0499) — DRUG
  Patients will receive subcutaneous (s.c., under the skin) injections of placebo once weekly The study will last for about 19 months
• Semaglutide 3 mg/mL — DRUG
  Patients will receive subcutaneous (s.c., under the skin) injections of semaglutide once weekly The study will last for about 19 months
• Semaglutide placebo — DRUG
  Patients will receive subcutaneous (s.c., under the skin) injections of semaglutide placebo once weekly The study will last for about 19 months
• NNC0174 0833 10 mg/mL — DRUG
  Patients will receive subcutaneous (s.c., under the skin) injections of NNC0174-0833 once weekly The study will last for about 19 months
• NNC0174 0833 placebo — DRUG
  Patients will receive subcutaneous (s.c., under the skin) injections of NNC0174-0833 placebo once weekly The study will last for about 19 months

Study Details

This study is being done to see if a combination of 2 medicines (called NNC0194-0499 and semaglutide) can reduce liver damage in patients with non alcoholic steatohepatitis (NASH). NNC0194-0499 is a new medicine which works in the liver. Semaglutide is a well-known medicine, which is already used by doctors to treat type 2 diabetes in many countries. It also helps with weight loss and may reduce liver damage, and so prevent future liver complications. It works in a different way to NNC0194 0499. The 2 medicines may work better together than on their own. The study will also look at a combination of semaglutide and another weight-loss medicine called NNC0174-0833, which may be another treatment option for NASH. Each week, participants will get 2 injections. These could be 2 of the 3 medicines OR 1 of the medicines and a placebo OR 2 placebo injections. Which treatment participants get is decided by chance. A placebo is a dummy medicine which looks like the real medicine but doesn't contain any active medicine. The study will last for about 19 months. Participants will have 14 clinic visits and 9 phone calls with the study doctor. Participants will have 1 or 2 liver biopsies (tiny pieces of liver tissue) - one at the start (if participants have not had a biopsy recently) and one at the end of the study treatment. Women: Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

Key Dates

Start date

Aug 31, 2021

Status verified

Nov 2025

Primary completion

Dec 17, 2024

Completion

Mar 14, 2025

Study Design

Enrollment

698 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: NNC0194-0499 7.5 mg + semaglutide 2.4 mg
  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.
• Placebo Comparator: Placebo (NNC0194-0499) 7.5 mg + semaglutide placebo 2.4 mg
  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.
• Experimental: NNC0194-0499 15 mg + semaglutide 2.4 mg
  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.
• Placebo Comparator: Placebo (NNC0194-0499) 15 mg + semaglutide placebo 2.4 mg
  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.
• Experimental: NNC0194-0499 30 mg + semaglutide 2.4 mg
  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.
• Experimental: NNC0194-0499 30 mg + semaglutide placebo 2.4 mg
  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.
• Active Comparator: Placebo (NNC0194-0499) 30 mg + semaglutide 2.4 mg
  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.
• Placebo Comparator: Placebo (NNC0194-0499) 30 mg + semaglutide placebo 2.4 mg
  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.
• Experimental: NNC0174-0833 2.4 mg + semaglutide 2.4 mg
  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.
• Placebo Comparator: Placebo (NNC0174-0833) 2.4 mg + semaglutide placebo 2.4 mg
  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.

Primary Outcome Measure

Improvement in liver fibrosis and no worsening of NASH (Yes/No) [ Time Frame: From baseline (week 0) to week 52 ]

Locations (70)

Find similar trials in Huntsville, AL

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