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AzTrials

Non-alcoholic Steatohepatitis (NASH)Phase 2NCT04771273

A Study to Test Safety and Efficacy of Survodutide (BI456906) in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)

A Phase 2 study testing Survodutide in people with Non-alcoholic Steatohepatitis (NASH), run by Boehringer Ingelheim at 154 sites in 25 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is open for men and women with a liver disease called nonalcoholic steatohepatitis (NASH) and liver fibrosis. The purpose of the study is to find out whether a medicine called BI 456906 helps patients with NASH and liver fibrosis. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Non-alcoholic Steatohepatitis (NASH)
What is being tested?
Survodutide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
295 participants
Where
154 sitesin 25 countries
Study dates
27 Apr 2021to 21 Dec 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients ≥ 18 years (or who are of legal age in countries where that is greater than 18 years) and ≤ 80 years of age at time of consent.
  • Diagnosis of non-alcoholic steatohepatitis (NASH) (Non-alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) ≥ 4, with at least 1 point in inflammation and ballooning each) and fibrosis stage F1-F3 proven by a biopsy conducted during the screening period or by a historical biopsy conducted within the last 6 months prior to randomization and stable body weight defined as less than 5% self-reported change in body weight between the historical biopsy and randomization, if a historical biopsy is used.
  • Liver fat fraction ≥ 8% measured by Magnetic Resonance Imaging (MRI)-Proton Density Fat Fraction (PDFF) and liver stiffness > 6.0 kPa measured by FibroScan® at Visit 1 (if biopsy is scheduled during the screening period MRI-PDFF and FibroScan® assessments have to be performed prior to the biopsy). However, the diagnosis of NASH and fibrosis at liver biopsy (including historical biopsy) is the primary assessment to establish patient eligibility.
  • Patients willing and able to undergo liver biopsies per protocol as judged by the Investigator.
  • Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
  • Women of childbearing potential (WOCBP)1 must be willing and able to use two forms of effective contraception where at least one form is highly effective methods of birth control per International Council on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
  • Further inclusion criteria apply.

Who cannot join

  • Current or history of significant alcohol consumption (defined as intake of > 210 g/ week in males and > 140 g/ week in females on average over a consecutive period of more than 3 months) or inability to reliably quantify alcohol consumption based on Investigator judgement within the last 5 years.
  • Intake of medications historically associated with liver injury, hepatic steatosis or steatohepatitis within 12 weeks prior to Visit 1. Intake of restricted medications or any medications considered likely to interfere with the safe conduct of the trial.
  • History of other forms of chronic liver disease (e.g., viral hepatitis, autoimmune liver disease, primary biliary sclerosis, primary sclerosing cholangitis, Wilson's disease, hemochromatosis, Alpha-1 Antitrypsin (A1At) deficiency, history of liver transplantation). Hepatitis B and C testing will be done at Visit 1. Patients with positive Hepatitis B surface antigen (HBsAg) should be excluded. Patients treated for hepatitis C must have a negative RNA test at screening and also be Hepatitis C Virus (HCV) RNA negative for at least 3 years prior to screening in order to be eligible for the trial.
  • Suspicion, diagnosis, or history of hepatocellular carcinoma (HCC), or any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix.
  • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, manifest hypo- or hyperthyroidism at Visit 1.
  • History of chronic or acute pancreatitis or elevation of serum lipase/amylase > 2x ULN or fasting serum triglyceride levels of > 500 mg/dL (> 5.65 mmol/L) at screening.
  • Known history of HIV (Human Immunodeficiency Virus) infection and/or tuberculosis and/or an acute COVID-19 infection at Visit 1 (confirmed by SARS CoV-2 RT-PCR test). Further exclusion criteria apply.

Trial locations and contacts

154 sites in 25 countries.

154 sites in 25 countries

United States36 sites

  • Texas Clinical Research Institute, LLC

    Arlington, Texas, 76012

  • Texas Liver Institute

    Austin, Texas, 78757

  • Delta Research Partners, LLC

    Bastrop, Louisiana, 71220

  • National Diabetes and Obesity Research Institute

    Biloxi, Mississippi, 39532

  • South Texas Research Institute

    Brownsville, Texas, 78520

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907

  • Northeast GI Research Division

    Concord, North Carolina, 28027

  • Southern California Research Center

    Coronado, California, 92118

  • Integrity Clinical Research, LLC

    Doral, Florida, 33166

  • South Texas Research Institute

    Edinburg, Texas, 78539

  • NECCR PrimaCare Research, LLC

    Fall River, Massachusetts, 02721

  • AIG Digestive Disease Research

    Florham Park, New Jersey, 07932

  • Gastrointestinal Associates

    Flowood, Mississippi, 39232

  • Covenant Metabolic Specialists, LLC

    Fort Myers, Florida, 33912

  • Digestive Diseases Research Center

    Greenwood, South Carolina, 29646

  • Digestive Health Research, LLC

    Hermitage, Tennessee, 37076

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Velocity Clinical Research

    Huntington Park, California, 90255

  • North Alabama Health Research, LLC

    Huntsville, Alabama, 35801

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Centex Studies, Inc.

    Lake Charles, Louisiana, 70601

  • Gastrointestinal Specialists of Georgia

    Marietta, Georgia, 30060

  • Tandem Clinical Research

    Marrero, Louisiana, 70072

  • Optimus U Corporation

    Miami, Florida, 33135

  • Sanchez Clinical Research ,Inc

    Miami, Florida, 33157

  • Lucas Research, Inc.

    Morehead City, North Carolina, 28557

  • Ocala GI Research

    Ocala, Florida, 34471

  • Omega Research Orlando, LLC

    Orlando, Florida, 32808

  • Velocity Clinical Research

    Panorama City, California, 91402

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • American Research Corporation at the Texas Liver Institute

    San Antonio, Texas, 78215

  • Pinnacle Clinical Research

    San Antonio, Texas, 78229

  • Quest Clinical Research

    San Francisco, California, 94115

  • Covenant Metabolic Specialists, LLC

    Sarasota, Florida, 34240

  • Digestive Research Alliance of Michiana

    South Bend, Indiana, 46635

  • Palmetto Clinical Research

    Summerville, South Carolina, 29485

Other trials in United States

Japan21 sites

  • Ehime University Hospital

    Ehime, Toon, 791-0295

  • Fukuiken Saiseikai Hospital

    Fukui, Fukui, 918-8503

  • Kurume University Hospital

    Fukuoka, Kurume, 830-0011

  • Ogaki Municipal Hospital

    Gifu, Ogaki, 503-8502

  • Japan Community Health Care Organization Hokkaido Hospital

    Hokkaido, Sapporo, 062-8618

  • Kagawa University Hospital

    Kagawa, Kita-gun, 761-0793

  • Kagawa Prefectural Central Hospital

    Kagawa, Takamatsu, 760-8557

  • St. Marianna University Hospital

    Kanagawa, Kawasaki, 216-8511

  • Kitasato University Hospital

    Kanagawa, Sagamihara, 252-0375

  • Yokohama City University Hospital

    Kanagawa, Yokohama, 236-0004

  • National Hospital Organization Yokohama Medical Center

    Kanagawa, Yokohama, 245-8575

  • Kumamoto University Hospital

    Kumamoto, Kumamoto, 860-8556

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, Kyoto, 602-8566

  • Shinshu University Hospital

    Nagano, Matsumoto, 390-8621

  • Nagano Municipal Hospital

    Nagano, Nagano, 381-8551

  • Nara Medical University Hospital

    Nara, Kashihara, 634-8522

  • Suita Hospital

    Osaka, Suita, 564-0013

  • Saga University Hospital

    Saga, Saga, 849-8501

  • Hamamatsu University Hospital

    Shizuoka, Hamamatsu, 431-3192

  • Juntendo University Shizuoka Hospital

    Shizuoka, Izunokuni, 410-2295

  • Tokyo Medical and Dental University Hospital

    Tokyo, Bunkyo-ku, 113-8519

Other trials in Japan

China13 sites

  • Beijing Ditan Hospital Capital Medical University

    Beijing, 100015

  • Beijing Tsinghua Changgung Hospital

    Beijing, 100044

  • Peking University People's Hospital

    Beijing, 100044

  • Beijing Friendship Hospital

    Beijing, 100050

  • The First Hospital of Jilin University

    Changchun, 130021

  • The First Afiliated Hospital, Sun Yet-sen University

    Guangzhou, 510080

  • NanFang Hosptial

    Guangzhou, 510515

  • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

    Hangzhou, 310016

  • First People's hospital of Yunann Province

    Kunming, 650032

  • The Second Hospital of Nanjing

    Nanjing, 210003

  • Shanghai Public Health Clinical Center

    Shanghai, 201508

  • Tianjin Third Central Hospital

    Tianjin, 300170

  • The First Affiliated Hospital of Wenzhou Med College

    Wenxzhou, 325000

Other trials in China

Poland11 sites

  • INTERCORE Medical Center

    Bydgoszcz, 85-605

  • Synexus Poland, Branch in Czestochowa

    Częstochowa, 42202

  • Private health care facility "Your Health EL" LLC

    Elblag, 82-300

  • Synexus Polska SCM Sp. z o.o. Gdansku, Gdansk

    Gdansk, 80-382

  • Synexus Polska Sp. z o.o. Oddzial w Gdyni, Gdynia

    Gdynia, 81-384

  • University Clinical Center Professor Gibinskiego

    Katowice, 40-752

  • University Hospital in Krakow

    Krakow, 30688

  • Medicome Limited Liability Company

    Oświęcim, 32600

  • Centrum Medyczne Synexus

    Warsaw, 01-192

  • Synexus Poland, Branch in Wroclaw

    Wroclaw, 50-088

  • ETG Zamosc

    Zamość, 22400

Other trials in Poland

Germany9 sites

  • Universitätsklinikum Aachen, AöR

    Aachen, 52074

  • Synexus Clinical Research GmbH

    Berlin, 12627

  • Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH

    Bochum, 44892

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

  • Synexus Clinical Research GmbH

    Frankfurt, 60313

  • Synexus Clinical Research GmbH

    Leipzig, 04103

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131

  • Universitätsklinikum Mannheim GmbH

    Mannheim, 68167

  • Universitätsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Italy6 sites

  • Ospedale Civile di Baggiovara

    Baggiovara (MO), 41126

  • A.O. Univ. Policlinico "Paolo Giaccone"

    Palermo, 90127

  • Poli Univ A. Gemelli

    Roma, 00195

  • Istituto Clinico Humanitas

    Rozzano (MI), 20089

  • IRCCS Ospedale "Casa Sollievo della Sofferenza"

    SAN Giovanni Rotondo (FG), 71013

  • AO Città della Salute e Scienza

    Torino, 10126

Other trials in Italy

Spain6 sites

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Puerta de Hierro

    Majadahonda, 28222

  • Hospital de Montecelo

    Pontevedra, 36071

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

  • Hospital Virgen del Rocío

    Seville, 41013

  • Hospital General Universitario de Valencia

    Valencia, 46014

Other trials in Spain

Israel5 sites

  • Shaare Zedek Medical Center, Jerusalem 91031

    Jerusalem, 9103102

  • Western Galilee Hospital

    Nahariya, 22100

  • Rabin Medical Center Beilinson

    Petah Tikva, 49100

  • Sourasky Medical Center

    Tel Aviv, 64239

  • The Chaim Sheba Medical Center

    Tel HaShomer, 5265601

Other trials in Israel

United Kingdom5 sites

  • Queen Elizabeth Hospital

    Birmingham, B15 2TH

  • Synexus - Hexham

    Hexham, NE46 1QJ

  • Aintree University Hospital

    Liverpool, L9 7AL

  • King's College Hospital

    London, SE5 9RS

  • Queen's Medical Centre

    Nottingham, NG7 2RD

Other trials in United Kingdom

France4 sites

  • HOP l'Archet

    Nice, 06200

  • HOP La Pitié Salpêtrière

    Paris, 75651

  • HOP Haut-Lévêque

    Pessac, 33604

  • HOP Civil

    Strasbourg, 67091

Other trials in France

Taiwan4 sites

  • Chia Yi Christian Hospital

    Chiayi City, 60002

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • National Chen Kung University, Dept of Neurology

    Tainan, 704

  • Chang Gung Memorial Hospital(Linkou)

    Taoyuan County, 333

Other trials in Taiwan

Australia3 sites

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Gold Coast University Hospital

    Southport, Queensland, 4215

Other trials in Australia

Austria3 sites

  • Medical University of Graz State Hospital - University Hospital Graz

    Graz, 8036

  • Medical University of Innsbruck

    Innsbruck, A-6020

  • Ordensklinikum Linz GmbH - Barmherzige Schwestern

    Linz, A-4010

Other trials in Austria

Canada3 sites

  • Ecogene-21

    Chicoutimi, Quebec, G7H 7K9

  • University Hospital (LHSC)

    London, Ontario, N6A 5A5

  • Toronto Liver Centre

    Toronto, Ontario, M6H 3M1

Other trials in Canada

Hungary3 sites

  • Synexus Hungary Healthcare Service Ltd.

    Budapest, 1036

  • Fed.St. Istvan&Szent Laszlo Hospital

    Budapest, 1097

  • Synexus Hungary Healthcare Service Ltd

    Gyula, 5700

Other trials in Hungary

Malaysia3 sites

  • Universiti Sains Malaysia Hospital

    Kelantan, 16150

  • University of Malaya Medical Centre

    Kuala Lumpur, 59100

  • Hospital Selayang

    Kuala Selangor, 68100

Other trials in Malaysia

Netherlands3 sites

  • Amsterdam UMC, location VUMC

    Amsterdam, 1105 AZ

  • Leids Universitair Medisch Centrum (LUMC)

    Leiden, 2333 ZA

  • Sint Franciscus, Locatie Vlietland

    Rotterdam, 3045 PM

Other trials in Netherlands

South Korea3 sites

  • Pusan National Univ. Hosp

    Busan, 49241

  • Keimyung University Dongsan Hospital

    Daegu, 42601

  • Seoul National University Hospital

    Seoul, 03080

Other trials in South Korea

Czechia2 sites

  • Regional Hospital Liberec

    Liberec, 460 63

  • General Faculty Hospital, Prague

    Prague, 128 08

Other trials in Czechia

Greece2 sites

  • Attikon University Hospital

    Haidari-Athens, 12462

  • General Hospital of Thessaloniki "Hippokrateio"

    Thessaloniki, 54642

Other trials in Greece

Hong Kong2 sites

  • Prince of Wales Hospital

    Hong Kong, 999077

  • Queen Mary Hospital

    Hong Kong, 999077

Other trials in Hong Kong

New Zealand2 sites

  • New Zealand Clinical Research (NZCR)

    Auckland, 1010

  • Middlemore Clinical Trials

    Papatoetoe, 2025

Other trials in New Zealand

Portugal2 sites

  • ULS de Santa Maria, E.P.E

    Lisbon, 1649-035

  • Centro Hospitalar Universitário São João,EPE

    Porto, 4202-451

Other trials in Portugal

Singapore2 sites

  • National University Hospital

    Singapore, 119074

  • Singapore General Hospital

    Singapore, 168753

Other trials in Singapore

Belgium1 site

  • Edegem - UNIV UZ Antwerpen

    Edegem, 2650

Other trials in Belgium

About this study

Official title: Multicenter, Double-blind, Parallel-group, Randomized, 48 Weeks, Dose-ranging, Placebo-controlled Phase II Trial to Evaluate Efficacy, Safety and Tolerability of Multiple Subcutaneous (s.c.) Doses of BI 456906 in Patients With Non-alcoholic Steatohepatitis (NASH) and Fibrosis.

This study is open for men and women with a liver disease called nonalcoholic steatohepatitis (NASH) and liver fibrosis. The purpose of the study is to find out whether a medicine called BI 456906 helps patients with NASH and liver fibrosis. The study tests 3 different doses of BI 456906 to find the dose that helps best. Participants are put into 4 groups randomly, which means by chance. There are 3 groups that each receive a different dose of BI 456906 and there is 1 group that receives placebo. BI 456906 and placebo are given as an injection under the skin once per week. The placebo injection looks like the BI 456906 injection but does not contain any medicine.

Participants are in the study for a little over 1 year (60 weeks). During this time, they visit the study site several times and have some video calls in addition. At the visits, the study doctors take different measurements. To see whether the treatment works, the doctors take a very small sample of liver tissue (biopsy) from each participant at the start and at the end of the study. They also examine the liver by ultrasound and MRI. The doctors also regularly check the general health of the participants.

Being tested
Survodutide, Placebo
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurvodutideDrug

    Also called BI 456906

    Survodutide

  • PlaceboDrug

    Placebo

Study groups in NCT04771273
Study groupRoleWhat they receive
Survodutide 2.4 mg - planned maintenance treatmentExperimentalNot described
Receives: Drug: Survodutide
Survodutide 4.8 mg - planned maintenance treatmentExperimentalNot described
Receives: Drug: Survodutide
Survodutide 6.0 mg - planned maintenance treatmentExperimentalNot described
Receives: Drug: Survodutide
Placebo - planned maintenance treatmentPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement (Yes/ no) From Baseline in Liver Histological Findings Based on Liver Biopsy After 48 Weeks of Treatment in Patients With NASH (NAS ≥ 4, Fibrosis F1-F3) - Actual Maintenance Treatment

    Percentage of patients who had an improvement from baseline in liver histological findings based on liver biopsy after 48 weeks of treatment is reported. Percentages were rounded to one decimal place.

    Improvement in histological findings was defined as a composite of improvement in NASH and no worsening of fibrosis.

    Improvement in non-alcoholic steatohepatitis (NASH) was defined as decrease of at least 2 points in non-alcoholic fatty liver disease (NAFLD) activity score (NAS) with at least 1 point decrease in NAS subscore of either lobular inflammation or ballooning.

    The NAS represents the sum of subscores for steatosis (scored from 0-3), lobular inflammation (scored from 0-3) and ballooning (scored from 0-2), and the total score ranges from 0 to 8 with higher scores representing worsening of the disease.

    The total score for the fibrosis stage ranges from 0 to 4 with higher score indication worsening of the disease.

    Patients without post-baseline data were considered non-responders.

    Measured: At baseline and at 48 weeks.

  2. Improvement (Yes/ no) From Baseline in Liver Histological Findings Based on Liver Biopsy After 48 Weeks of Treatment in Patients With NASH (NAS ≥ 4, Fibrosis F1-F3) - Planned Maintenance Treatment

    Percentage of patients who had an improvement from baseline in liver histological findings based on liver biopsy after 48 weeks of treatment is reported. Percentages were rounded to one decimal place.

    Improvement in histological findings was defined as a composite of improvement in non-alcoholic steatohepatitis (NASH) and no worsening of fibrosis.

    Improvement in NASH was defined as decrease of at least 2 points in non-alcoholic fatty liver disease (NAFLD) activity score (NAS) with at least 1 point decrease in NAS subscore of either lobular inflammation or ballooning.

    The NAS represents the sum of subscores for steatosis (scored from 0-3), lobular inflammation (scored from 0-3) and ballooning (scored from 0-2), and the total score ranges from 0 to 8 with higher scores representing worsening of the disease.

    The total score for the fibrosis stage ranges from 0 to 4 with higher score indication worsening of the disease.

    Patients without post-baseline data were considered non-responders.

    Measured: At baseline and after 48 weeks of treatment.

Secondary outcomes (10)

  1. Improvement of Liver Fat Content (Yes/ no) Defined as at Least 30% Relative Reduction in Liver Fat Content After 48 Weeks of Treatment Compared to Baseline Assessed by MRI-PDFF - Actual Maintenance Treatment

    Percentage of participants with improvement in liver fat content is reported. Improvement in liver fat content was defined as percentage reduction from baseline of ≥30% in liver fat content after 48 weeks of treatment compared to baseline. Percentages were rounded to one decimal place.

    Liver fat content was assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF).

    Patients without post-baseline values were imputed as non-responders.

    Measured: At baseline and after 48 weeks.

  2. Improvement of Liver Fat Content (Yes/ no) Defined as at Least 30% Relative Reduction in Liver Fat Content After 48 Weeks of Treatment Compared to Baseline Assessed by MRI-PDFF - Planned Maintenance Treatment

    Percentage of participants with improvement in liver fat content is reported. Improvement in liver fat content was defined as percentage reduction from baseline of ≥30% in liver fat content after 48 weeks of treatment compared to baseline.

    Liver fat content was assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF).

    Patients without post-baseline values were imputed as non-responders.

    Measured: At baseline and at 48 weeks.

  3. Absolute Change of Liver Fat Content From Baseline After 48 Weeks of Treatment Assessed by MRI-PDFF - Actual Maintenance Treatment

    Absolute change of liver fat content (percentage [%]) from baseline after 48 weeks of treatment is reported. Liver fat content was assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF).

    Least Squares Mean (Standard error) were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type [yes, no], baseline fibrosis score [F1, F2, F3], visit, treatment by visit interaction and baseline by visit interaction as factors.

    Measured: MMRM included measurements from baseline and at Week 28 and at Week 48 after first drug administration. MMRM estimates of absolute change from baseline to Week 48 is reported.

  4. Absolute Change of Liver Fat Content From Baseline After 48 Weeks of Treatment Assessed by MRI-PDFF - Planned Maintenance Treatment

    Absolute change of liver fat content from baseline after 48 weeks of treatment is reported. Liver fat content was assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF).

    Least Squares Mean (Standard error) were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type [yes, no], baseline fibrosis score [F1, F2, F3], visit, treatment by visit interaction and baseline by visit interaction as factors.

    Measured: MMRM included measurements from baseline and at Week 28 and at Week 48 after first drug administration. MMRM estimates of absolute change from baseline to Week 48 is reported.

  5. Percent Change of Liver Fat Content From Baseline After 48 Weeks of Treatment Assessed by MRI-PDFF - Actual Maintenance Treatment

    Percent change of liver fat content (percentage [%]) from baseline after 48 weeks of treatment is reported. Liver fat content was assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF).

    Least Squares Mean (Standard error) were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type [yes, no], baseline fibrosis score [F1, F2, F3], visit, treatment by visit interaction and baseline by visit interaction as factors.

    Measured: MMRM included measurements from baseline and at Week 28 and at Week 48 after first drug administration. MMRM estimates of percent change from baseline to Week 48 is reported.

  6. Percent Change of Liver Fat Content From Baseline After 48 Weeks of Treatment Assessed by MRI-PDFF - Planned Maintenance Treatment

    Percent change of liver fat content (percentage [%]) from baseline after 48 weeks of treatment is reported. Liver fat content was assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF).

    Least Squares Mean (Standard error) were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type [yes, no], baseline fibrosis score [F1, F2, F3], visit, treatment by visit interaction and baseline by visit interaction as factors.

    Measured: MMRM included measurements from baseline and at Week 28 and at Week 48 after first drug administration. MMRM estimates of percent change from baseline to Week 48 is reported.

  7. Improvement of Fibrosis (Yes/ no) Defined as at Least One Stage Decrease in Fibrosis Stage After 48 Weeks of Treatment Assessed by Liver Biopsy - Actual Maintenance Treatment

    Percentage of participants with improvement of liver fibrosis is reported. Improvement of fibrosis was defined as at least one stage decrease in fibrosis stage after 48 weeks of treatment assessed by liver biopsy.

    The total score for the fibrosis stage ranges from 0 to 4 with higher score indication worsening of the disease and the stages of fibrosis based on their location are the following:

    • 1A Zone 3, perisinusoidal, delicate;
    • 1B Zone 3, perisinusoidal, dense;
    • 1C Portal, periportal only;
    • 2 Zone 3, perisinusoidal + portal, periportal only;
    • 3 Bridging fibrosis;
    • 4 Cirrhosis. For analysis purposes no distinction was made between stages 1A, 1B and 1C.

    Measured: At baseline and after 48 weeks of treatment.

  8. Improvement of Fibrosis (Yes/ no) Defined as at Least One Stage Decrease in Fibrosis Stage After 48 Weeks of Treatment Assessed by Liver Biopsy - Planned Maintenance Treatment

    Percentage of participants with improvement of liver fibrosis is reported. Improvement of fibrosis was defined as at least one stage decrease in fibrosis stage after 48 weeks of treatment assessed by liver biopsy.

    The total score for the fibrosis stage ranges from 0 to 4 with higher score indication worsening of the disease and the stages of fibrosis based on their location are the following:

    • 1A Zone 3, perisinusoidal, delicate;
    • 1B Zone 3, perisinusoidal, dense;
    • 1C Portal, periportal only;
    • 2 Zone 3, perisinusoidal + portal, periportal only;
    • 3 Bridging fibrosis;
    • 4 Cirrhosis. For analysis purposes no distinction was made between stages 1A, 1B and 1C.

    Measured: At baseline and after 48 weeks of treatment.

  9. Absolute Change From Baseline in NAS After 48 Weeks of Treatment Assessed by Liver Biopsy - Actual Maintenance Treatment

    Absolute change from baseline in NAS after 48 weeks of treatment assessed by liver biopsy is reported.

    The non-alcoholic fatty liver disease (NAFLD) activity score (NAS) represents the sum of subscores for steatosis (scored from 0-3), lobular inflammation (scored from 0-3) and ballooning (scored from 0-2), and the total score ranges from 0 to 8 with higher scores representing worsening of the disease.

    Measured: At baseline and 48 weeks of treatment.

  10. Absolute Change From Baseline in NAS After 48 Weeks of Treatment Assessed by Liver Biopsy - Planned Maintenance Treatment

    Absolute change from baseline in NAS after 48 weeks of treatment assessed by liver biopsy is reported.

    The non-alcoholic fatty liver disease (NAFLD) activity score (NAS) represents the sum of subscores for steatosis (scored from 0-3), lobular inflammation (scored from 0-3) and ballooning (scored from 0-2), and the total score ranges from 0 to 8 with higher scores representing worsening of the disease.

    Measured: At baseline and 48 weeks of treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2021
  2. Study start27 Apr 2021
  3. Primary completion9 Nov 2023
  4. Study completion21 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
295 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04771273
Sponsor's protocol ID
1404-0043
Other IDs
2020-002723-11
Status last verified
Nov 2024
First submitted
24 Feb 2021
Last updated
3 Dec 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

Publications

  • Sanyal AJ, Bedossa P, Fraessdorf M, Neff GW, Lawitz E, Bugianesi E, Anstee QM, Hussain SA, Newsome PN, Ratziu V, Hosseini-Tabatabaei A, Schattenberg JM, Noureddin M, Alkhouri N, Younes R; 1404-0043 Trial Investigators. A Phase 2 Randomized Trial of Survodutide in MASH and Fibrosis. N Engl J Med. 2024 Jul 25;391(4):311-319. doi: 10.1056/NEJMoa2401755. Epub 2024 Jun 7.

    PubMed 38847460

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Survodutide in people with Non-alcoholic Steatohepatitis (NASH), run by Boehringer Ingelheim at 154 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 154 sites in United States, Japan, China, Poland, Germany and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement (Yes/ no) From Baseline in Liver Histological Findings Based on Liver Biopsy After 48 Weeks of Treatment in Patients With NASH (NAS ≥ 4, Fibrosis F1-F3) - Actual Maintenance Treatment (time frame: At baseline and at 48 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04771273, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.

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