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

Summary

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.

Conditions

• Non-alcoholic Steatohepatitis

Interventions

DRUG

NNC0194 0499 50 mg/mL

Patients will receive subcutaneous (s.c., under the skin) injections of NNC0194-0499 once weekly The study will last for about 19 months

DRUG

Placebo (NNC0194-0499)

Patients will receive subcutaneous (s.c., under the skin) injections of placebo once weekly The study will last for about 19 months

DRUG

Semaglutide 3 mg/mL

Patients will receive subcutaneous (s.c., under the skin) injections of semaglutide once weekly The study will last for about 19 months

DRUG

Semaglutide placebo

Patients will receive subcutaneous (s.c., under the skin) injections of semaglutide placebo once weekly The study will last for about 19 months

DRUG

NNC0174 0833 10 mg/mL

Patients will receive subcutaneous (s.c., under the skin) injections of NNC0174-0833 once weekly The study will last for about 19 months

DRUG

NNC0174 0833 placebo

Patients will receive subcutaneous (s.c., under the skin) injections of NNC0174-0833 placebo once weekly The study will last for about 19 months

Sponsors & Collaborators

• Novo Nordisk A/S

  lead INDUSTRY

Principal Investigators

• Clinical Transparency (dept. 1452) · Novo Nordisk A/S

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-31

Primary Completion

2024-12-17

Completion

2025-03-14

FDA Drug

Yes

Countries

• United States
• Australia
• Belgium
• Bulgaria
• Canada
• Czechia
• Denmark
• France
• Germany
• Greece
• India
• Italy
• Japan
• Malaysia
• Poland
• Portugal
• Puerto Rico
• Russia
• Singapore
• South Korea
• Spain
• Taiwan
• Turkey (Türkiye)
• United Kingdom

Study Locations