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Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT05016882

Public ClinicalTrials.gov record NCT05016882. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 3:31 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Efficacy and Safety Investigation of NNC0194-0499 Co-administered With Semaglutide in Subjects With Non-alcoholic Steatohepatitis: a Dose-ranging, Placebo Controlled Trial

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05016882
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Novo Nordisk A/S
Industry
Enrollment
698 participants

Conditions and interventions

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 31, 2021 (Actual)
Primary completion
Dec 17, 2024 (Actual)
Completion
Mar 14, 2025 (Actual)
Last update posted
Nov 19, 2025

2021 – 2025

United States locations

U.S. sites
70
U.S. states
23
U.S. cities
62
Facility City State ZIP Site status
North AL Health Res, LLC Huntsville Alabama 35801 —
The Institute for Liver Health Chandler Arizona 85224 —
Inst-Liver Hlth dba AZ Liver H Peoria Arizona 85381 —
Del Sol Research Management, LLC Tucson Arizona 85715 —
Hope Clinical Research Canoga Park California 91303 —
UCSD NAFLD Research Center La Jolla California 92037 —
OM Research LLC Lancaster California 93534 —
Digestive Hlth Res of SoCa Long Beach California 90808 —
Stanford Medicine Redwood City California 94063 —
UC Davis Hlth -Midtwn Ambu Cen Sacramento California 95817 —
Peak Gastro Assoc-Col Springs Colorado Springs Colorado 80907 —
Hartford Hsptl_Hartford Hartford Connecticut 06106 —
Integrity Clinical Research, LLC Doral Florida 33122 —
Miguel Rebollar PA Hialeah Florida 33012 —
Nature Coast Clinical Research_Inverness Inverness Florida 34452 —
UF Hlth Jacksonville Jacksonville Florida 32224 —
Florida Research Institute, LLC Lakewood Rch Florida 34211 —
ClinCloud,LLC Maitland Florida 32751 —
Optimus U, Corp Miami Florida 33135 —
Univ of Miami/Schiff Ctr Miami Florida 33136 —
Covenant Metabolic Specialists LLC University Park Florida 34201 —
ClinCloud, LLC Viera E. Florida 32940 —
Florida Medical Clinic Orlando Health Zephyrhills Florida 33542 —
Florida Medical Clinic, LLC Zephyrhills Florida 33542 —
Piedmont Healthcare Atlanta Georgia 30309 —
Digestive Healthcare of Georgia Atlanta Georgia 30327 —
Gastroenterology Assoc_ CGA Macon Georgia 31201 —
Gastroint Spec of Georgia Marietta Georgia 30060 —
EBGS Clinical Research Center, LLC Snellville Georgia 30078 —
Grand Teton Gastroenterology Idaho Falls Idaho 83404-7590 —
Digestive Research Alliance of Michiana South Bend Indiana 46635 —
University Of Kansas Hospital Kansas City Kansas 66160 —
Kansas Medical Clinic, PA Topeka Kansas 66606 —
Tandem Clinical Research - Houma Houma Louisiana 70363 —
Tandem Clinical Research Marrero Louisiana 70072 —
Tandem Clinical Research - Metairie Metairie Louisiana 70006 —
Louisiana Research Center, LLC Shreveport Louisiana 71105 —
Mercy Medical Center, GI Research Baltimore Maryland 21202 —
Walter Reed Nat Mil Md Ctr Bethesda Maryland 20889 —
Henry Ford Hospital_Detroit Detroit Michigan 48202 —
Kansas City Research Institute Kansas City Missouri 64131 —
Univ of Nebraska Medical CTR Omaha Nebraska 68198-3020 —
AIG Digestive Disease Research Florham Park New Jersey 07932 —
NYU Grossman School of Med New York New York 10016 —
Weill Cornell Med Coll-NYPH New York New York 10065 —
Univ Hosp Cleveland Med Ctr Cleveland Ohio 44106 —
Ohio State Univ Wexner Med Ctr Columbus Ohio 43210 —
DSI Research,LLC Springboro Ohio 45066 —
Geisinger Clinic Danville Pennsylvania 17822-2111 —
Pennsylvania State University Hershey Pennsylvania 17033 —
University of Pennsylvania Hospital Philadelphia Pennsylvania 19104 —
Thomas Jefferson University Hospital Philadelphia Pennsylvania 19107-5244 —
UPMC Center for Liver Diseases Pittsburgh Pennsylvania 15213 —
UPMC_Center for Liver Care Pittsburgh Pennsylvania 15213 —
Digestive Health Res-TSMC Hermitage Tennessee 37076 —
Quality Medical Research Nashville Tennessee 37211 —
Texas Clin Res Inst, LLC Arlington Texas 76012 —
Liver Ins@ Mthdist DTX Med Cen Dallas Texas 75203 —
Centex Studies, Inc. Houston Texas 77058 —
Amir Ali Hassan, MD, PA Houston Texas 77089 —
Texas Diabetes &Endocrinology Round Rock Texas 78681 —
Amer. Rrsch Corp-TX Liver Inst San Antonio Texas 78215 —
Olympus Clinical Research Sugar Land Texas 77478 —
Impact Research Waco Texas 76710 —
Digestive Hlth Res of N Texas Wichita Falls Texas 76301 —
Inova Fairfax Medical Campus Falls Church Virginia 22042 —
Bon Secours Richmond Community Hospital LLC Richmond Virginia 23226 —
Gastroent Consult of SW VA Roanoke Virginia 24014 —
Swedish med ctr org trans-lvr ctr Seattle Washington 98104 —
Liver Institute NW Seattle Washington 98105 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 185 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05016882, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 19, 2025 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05016882 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →