Efficacy and Safety Investigation of NNC0194-0499 Co-administered With Semaglutide in Subjects With Non-alcoholic Steatohepatitis: a Dose-ranging, Placebo Controlled Trial
Efficacy and Safety Investigation of NNC0194-0499 Co-administered With Semaglutide in Subjects With Non-alcoholic Steatohepatitis: a Dose-ranging, Placebo Controlled Trial
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.
Inclusion Criteria:
Exclusion Criteria:
Viera E., Florida 32940, United States
Goudi, Athens, 115 27, Greece
Secunderabad, Andhra Pradesh 500003, India
New Dehli, New Delhi 110029, India
Chandigarh,, Punjab 160062, India
Chandigarh, Punjab 160012, India
Chiba-shi, Chiba, 260-8677, Japan
Fukui-shi, Fukui, 918-8503, Japan
Hamamatsu-shi, Shizuoka, 431-3192, Japan
Hatsukaichi-shi, Hiroshima, 783-8503, Japan
Kamigyo-ku, Kyoto, 602-8566, Japan
Kumamoto-shi, Kumamoto, 862-8655, Japan
Minato-ku, Tokyo, 105-8470, Japan
Okayama-shi, Okayama, 700-8505, Japan
Saga-shi, Saga, 849-8501, Japan
Sendai-shi, Miyagi, 981-0914, Japan
Toon-shi, Ehime, 791-0295, Japan
Toon-shi, Ehime, 791-0295, Japan
Wakayama-shi, Wakayama, 640-8158, Japan
Wakayama-shi, Wakayama, 640-8158, Japan
Yokohama-shi, Kanagawa, 236-0004, Japan
Lembah Pantai, Kuala Lumpur 59100, Malaysia
Myslowice, Lesser Poland Voivodeship 41-400, Poland
Senhora Da Hora, Matosinhos, Matosinhos 4464-513, Portugal
Moscow, 117292, Russia
Gangwon-do, 26426, South Korea
Yüreğir/Adana, 1370, Turkey (Türkiye)