Clinical Trial Details

Trial ID: L0192
Source ID: NCT05016882
Associated Drug: Semaglutide
Title: Research Study on Whether a Combination of 2 Medicines (NNC0194 0499 and Semaglutide) Works in People With Non-alcoholic Steatohepatitis (NASH)
Acronym: --
Status: Recruiting
Study Results: No Results Available
Results: --
Conditions: Non-alcoholic Steatohepatitis
Interventions: Drug: NNC0194 0499 50 mg/mL|Drug: Placebo (NNC0194-0499)|Drug: Semaglutide 3 mg/mL|Drug: Semaglutide placebo|Drug: NNC0174 0833 10 mg/mL|Drug: NNC0174 0833 placebo
Outcome Measures: Improvement in liver fibrosis and no worsening of NASH (Yes/No)|Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No)|Improvement in steatohepatitis with at least a 2-point reduction in NAS and no worsening of fibrosis (Yes/No)|Change in histology-assessed liver collagen proportionate area|Resolution of steatohepatitis and improvement in liver fibrosis (Yes/No)|Improvement in liver fibrosis (Yes/No)|Progression of liver fibrosis (Yes/No)|Worsening in steatohepatitis (Yes/No)|Improvement in ballooning (Yes/No)|Improvement in inflammation (Yes/No)|Improvement in steatosis (Yes/No)|Change in ALT (alanine aminotransferase)|Change in AST (aspartate aminotransferase)|Change in inflammation assessed by HsCRP (high sensitivity C-reactive protein)|Change in ELF (Enhanced Liver Fibrosis) score|Change in HbA1c. For subjects with type 2 diabetes|Change in triglycerides|Change in free fatty acids|Change in LDL (low density lipoprotein) cholesterol|Change in HDL (high density lipoprotein) cholesterol|Relative change in body weight|Change in SF-36 (36-item Short Form Survey) bodily pain|Change in NASH-CHECK (patient-reported outcome measure for non-alcoholic steatohepatitis)pain|Change in PROMIS (Patient-Reported Outcomes Measurement Information System) Fatigue score|Number of treatment emergent adverse events (TEAEs)
Sponsor/Collaborators: Novo Nordisk A/S
Gender: All
Age: 18 Years and older ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 672
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
Start Date: August 31, 2021
Completion Date: September 20, 2024
Results First Posted: --
Last Update Posted: March 15, 2022
Locations: Novo Nordisk Investigational Site, Chandler, Arizona, United States|Novo Nordisk Investigational Site, Peoria, Arizona, United States|Novo Nordisk Investigational Site, Tucson, Arizona, United States|Novo Nordisk Investigational Site, Canoga Park, California, United States|Novo Nordisk Investigational Site, Lancaster, California, United States|Novo Nordisk Investigational Site, Long Beach, California, United States|Novo Nordisk Investigational Site, Hialeah, Florida, United States|Novo Nordisk Investigational Site, Inverness, Florida, United States|Novo Nordisk Investigational Site, Miami, Florida, United States|Novo Nordisk Investigational Site, Zephyrhills, Florida, United States|Novo Nordisk Investigational Site, Atlanta, Georgia, United States|Novo Nordisk Investigational Site, Macon, Georgia, United States|Novo Nordisk Investigational Site, Marietta, Georgia, United States|Novo Nordisk Investigational Site, Snellville, Georgia, United States|Novo Nordisk Investigational Site, South Bend, Indiana, United States|Novo Nordisk Investigational Site, Topeka, Kansas, United States|Novo Nordisk Investigational Site, Marrero, Louisiana, United States|Novo Nordisk Investigational Site, Shreveport, Louisiana, United States|Novo Nordisk Investigational Site, Baltimore, Maryland, United States|Novo Nordisk Investigational Site, Omaha, Nebraska, United States|Novo Nordisk Investigational Site, Florham Park, New Jersey, United States|Novo Nordisk Investigational Site, Philadelphia, Pennsylvania, United States|Novo Nordisk Investigational Site, Philadelphia, Pennsylvania, United States|Novo Nordisk Investigational Site, Pittsburgh, Pennsylvania, United States|Novo Nordisk Investigational Site, Hermitage, Tennessee, United States|Novo Nordisk Investigational Site, Nashville, Tennessee, United States|Novo Nordisk Investigational Site, Arlington, Texas, United States|Novo Nordisk Investigational Site, Houston, Texas, United States|Novo Nordisk Investigational Site, Houston, Texas, United States|Novo Nordisk Investigational Site, Round Rock, Texas, United States|Novo Nordisk Investigational Site, San Antonio, Texas, United States|Novo Nordisk Investigational Site, Wichita Falls, Texas, United States|Novo Nordisk Investigational Site, Richmond, Virginia, United States|Novo Nordisk Investigational Site, Roanoke, Virginia, United States|Novo Nordisk Investigational Site, Darlinghurst, New South Wales, Australia|Novo Nordisk Investigational Site, Westmead, New South Wales, Australia|Novo Nordisk Investigational Site, Fitzroy, Victoria, Australia|Novo Nordisk Investigational Site, Melbourne, Victoria, Australia|Novo Nordisk Investigational Site, Murdoch, Western Australia, Australia|Novo Nordisk Investigational Site, Bruxelles, Belgium|Novo Nordisk Investigational Site, Bruxelles, Belgium|Novo Nordisk Investigational Site, Edegem, Belgium|Novo Nordisk Investigational Site, Gent, Belgium|Novo Nordisk Investigational Site, Sofia, Bulgaria|Novo Nordisk Investigational Site, Sofia, Bulgaria|Novo Nordisk Investigational Site, Sofia, Bulgaria|Novo Nordisk Investigational Site, Calgary, Alberta, Canada|Novo Nordisk Investigational Site, Toronto, Ontario, Canada|Novo Nordisk Investigational Site, Angers, France|Novo Nordisk Investigational Site, Clichy, France|Novo Nordisk Investigational Site, Lyon Cedex 4, France|Novo Nordisk Investigational Site, NICE cedex 3, France|Novo Nordisk Investigational Site, Paris, France|Novo Nordisk Investigational Site, Saint Herblain, France|Novo Nordisk Investigational Site, Venissieux, France|Novo Nordisk Investigational Site, L??beck, Germany|Novo Nordisk Investigational Site, Mainz, Germany|Novo Nordisk Investigational Site, T??bingen, Germany|Novo Nordisk Investigational Site, W??rzburg, Germany|Novo Nordisk Investigational Site, Athens, Greece|Novo Nordisk Investigational Site, Goudi, Athens, Greece|Novo Nordisk Investigational Site, Thessaloniki, Greece|Novo Nordisk Investigational Site, Thessaloniki, Greece|Novo Nordisk Investigational Site, Secunderabad, Andhra Pradesh, India|Novo Nordisk Investigational Site, Mangalore, Karnataka, India|Novo Nordisk Investigational Site, Nagpur, Maharashtra, India|Novo Nordisk Investigational Site, Jaipur, Rajasthan, India|Novo Nordisk Investigational Site, Ancona, Italy|Novo Nordisk Investigational Site, Bergamo, Italy|Novo Nordisk Investigational Site, Firenze, Italy|Novo Nordisk Investigational Site, Padova, Italy|Novo Nordisk Investigational Site, Pisa, Italy|Novo Nordisk Investigational Site, Chiba-shi, Chiba, Japan|Novo Nordisk Investigational Site, Fukui-shi, Fukui, Japan|Novo Nordisk Investigational Site, Hamamatsu-shi, Shizuoka, Japan|Novo Nordisk Investigational Site, Hatsukaichi-shi, Hiroshima, Japan|Novo Nordisk Investigational Site, Kamigyo-ku, Kyoto, Japan|Novo Nordisk Investigational Site, Kawasaki-shi, Kanagawa, Japan|Novo Nordisk Investigational Site, Kumamoto-shi, Kumamoto, Japan|Novo Nordisk Investigational Site, Minato-ku, Tokyo, Japan|Novo Nordisk Investigational Site, Okayama-shi, Okayama, Japan|Novo Nordisk Investigational Site, Saga-shi, Saga, Japan|Novo Nordisk Investigational Site, Sendai-shi, Miyagi, Japan|Novo Nordisk Investigational Site, Suita-shi, Osaka, Japan|Novo Nordisk Investigational Site, Toon-shi, Ehime, Japan|Novo Nordisk Investigational Site, Wakayama-shi, Wakayama, Japan|Novo Nordisk Investigational Site, Yokohama-shi, Kanagawa, Japan|Novo Nordisk Investigational Site, Daegu, Korea, Republic of|Novo Nordisk Investigational Site, Daegu, Korea, Republic of|Novo Nordisk Investigational Site, Gangwon-do, Korea, Republic of|Novo Nordisk Investigational Site, Gyeonggi-do, Korea, Republic of|Novo Nordisk Investigational Site, Gyeonggi-do, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, Korea, Republic of|Novo Nordisk Investigational Site, Batu Caves, Malaysia|Novo Nordisk Investigational Site, Kuala Lumpur, Malaysia|Novo Nordisk Investigational Site, Bydgoszcz, Poland|Novo Nordisk Investigational Site, Katowice, Poland|Novo Nordisk Investigational Site, Katowice, Poland|Novo Nordisk Investigational Site, Krakow, Poland|Novo Nordisk Investigational Site, Krak??w, Poland|Novo Nordisk Investigational Site, Mys??owice, Poland|Novo Nordisk Investigational Site, Rzeszow, Poland|Novo Nordisk Investigational Site, Wroclaw, Poland|Novo Nordisk Investigational Site, Wroclaw, Poland|Novo Nordisk Investigational Site, Wroclaw, Poland|Novo Nordisk Investigational Site, San Juan, Puerto Rico|Novo Nordisk Investigational Site, Ekaterinburg, Russian Federation|Novo Nordisk Investigational Site, Novosibirsk, Russian Federation|Novo Nordisk Investigational Site, Novosibirsk, Russian Federation|Novo Nordisk Investigational Site, Omsk, Russian Federation|Novo Nordisk Investigational Site, Omsk, Russian Federation|Novo Nordisk Investigational Site, Penza, Russian Federation|Novo Nordisk Investigational Site, Saint Petersburg, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, Russian Federation|Novo Nordisk Investigational Site, Yoshkar-Ola, Russian Federation|Novo Nordisk Investigational Site, Singapore, Singapore|Novo Nordisk Investigational Site, Singapore, Singapore|Novo Nordisk Investigational Site, Singapore, Singapore|Novo Nordisk Investigational Site, Barcelona, Spain|Novo Nordisk Investigational Site, Majadahonda, Spain|Novo Nordisk Investigational Site, Pontevedra, Spain|Novo Nordisk Investigational Site, Santander, Spain|Novo Nordisk Investigational Site, Sevilla, Spain|Novo Nordisk Investigational Site, Exeter, United Kingdom|Novo Nordisk Investigational Site, London, United Kingdom
URL: https://ClinicalTrials.gov/show/NCT05016882

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D327 Semaglutide Chemical drug DB13928 GLP1R agonist Antidiabetic drug Under clinical trials Details
D094 Cysteamine Chemical drug DB00847 GSS stimulant Renal drug Under clinical trials Details
D095 Cysteamine bitartrate Chemical drug DB00847 -- -- Under clinical trials Details
D199 L-alanine Chemical drug DB00160 KYNU -- Failed in clinical trials Details
D498 NNC0194-0499 Chemical drug -- -- -- Under clinical trials Details