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AzTrials

Nonalcoholic SteatohepatitisPhase 2NCT04583423

A Study of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-3655-001)

A Phase 2 study testing MK-3655 in people with Nonalcoholic Steatohepatitis, run by Merck Sharp & Dohme LLC at 180 sites in 24 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study will evaluate the effect of each dose of MK-3655 versus placebo on the percentage of individuals with NASH resolution without worsening of fibrosis after 52 weeks. The primary hypothesis of the study is that at least 1 dose of MK-3655 is superior to placebo with respect to the percentage of individuals with… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Nonalcoholic Steatohepatitis
What is being tested?
MK-3655
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
183 participants
Where
180 sitesin 24 countries
Study dates
11 Nov 2020to 13 Apr 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

  • Has histological confirmation of NASH
  • Is a male or female aged 18 years to 80 years (in Japan and Taiwan aged 20 to 80 years)
  • Has a body mass index (BMI) ≥25 kg/m^2 and ≤50 kg/m^2 and stable weight for the past 3 months
  • Has no history of Type 2 diabetes mellitus (T2DM) OR a history of T2DM controlled by diet or stable doses of antihyperglycemic agents (AHAs)
  • Contraceptive use by male participants should be consistent with local regulations.
  • A female participant is eligible to participate if she is not pregnant or breastfeeding, and she is not a woman of child-bearing potential (WOCBP) OR she is a WOCBP and uses a contraceptive method that is highly effective during the intervention period and for at least 16 weeks after the last dose of study intervention.

Who cannot join

  • Has presence of cirrhosis on liver biopsy
  • Has Type 1 diabetes
  • Has a history of malignancy, unless cancer free ≥5 years, or is under evaluation for active or suspected malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
  • Has a history of bariatric surgery ≤5 years before study participation
  • Has undergone a major surgical procedure ≤3 months before study participation or has major surgery planned during the study
  • Has a history or evidence of chronic liver disease other than NASH. Individuals with a history of Hepatitis B or C may be eligible for participation.
  • Has significant systemic or major illnesses other than liver disease, including recent events (≤6 months before study entry) of congestive heart failure, unstable coronary artery disease, arterial revascularization, pulmonary disease, renal failure, stroke, transient ischemic attack, or organ transplantation

Trial locations and contacts

180 sites in 24 countries.

180 sites in 24 countries

United States48 sites

  • Texas Clinical Research Institute ( Site 2619)

    Arlington, Texas, 76012

  • The National Diabetes & Obesity Research Institute ( Site 9017)

    Biloxi, Mississippi, 39532

  • Hope Clinical Research, Inc. ( Site 2601)

    Canoga Park, California, 91303

  • Premier Medical Group ( Site 9010)

    Clarksville, Tennessee, 37040

  • Peak Gastroenterology Associates ( Site 2645)

    Colorado Springs, Colorado, 80920

  • Top Medical Research, Inc ( Site 2673)

    Cutler Bay, Florida, 33189

  • The Liver Institute at Methodist Dallas Medical Center ( Site 2638)

    Dallas, Texas, 75203

  • Southeast Clinical Research Center ( Site 9003)

    Dalton, Georgia, 30720

  • Velocity Clinical Research, Syracuse ( Site 9016)

    East Syracuse, New York, 13057

  • DHR Health Institute for Research and Development ( Site 9006)

    Edinburg, Texas, 78539

  • South Texas Research Institute ( Site 9012)

    Edinburg, Texas, 78539

  • Hillmont G.I. ( Site 9019)

    Flourtown, Pennsylvania, 19031

  • Covenant Metabolic Specialists, LLC ( Site 9027)

    Fort Myers, Florida, 33912

  • North Florida South Georgia Veterans Health System ( Site 2613)

    Gainesville, Florida, 32608

  • Indago Research and Health Center Inc ( Site 2610)

    Hialeah, Florida, 33012

  • Sweet Hope Research Specialty Inc ( Site 2660)

    Hialeah, Florida, 33016

  • Baylor College of Medicine - Advanced Liver Therapies ( Site 2670)

    Houston, Texas, 77030

  • The Crofoot Research Center, Inc. ( Site 2611)

    Houston, Texas, 77098

  • Velocity Clinical Research, Huntington Park ( Site 9022)

    Huntington Park, California, 90255

  • The University of Iowa ( Site 2655)

    Iowa City, Iowa, 52242

  • Kansas City Research Institute ( Site 9018)

    Kansas City, Missouri, 64131

  • UCSD - Altman Clinical and Translational Research Institute -UC San Diego NAFLD Research Center ( Si

    La Jolla, California, 92037

  • Regional Gastroenterology Associates of Lancaster, LTD ( Site 9020)

    Lancaster, Pennsylvania, 17601

  • Excel Clinical Research, LLC ( Site 2603)

    Las Vegas, Nevada, 89109

  • Ruane Clinical Research Group, Inc ( Site 9014)

    Los Angeles, California, 90036

  • Velocity Clinical Research, Westlake ( Site 9013)

    Los Angeles, California, 90057

  • Legacy Clinical Solutions: Tandem Clinical Research, LLC ( Site 2650)

    Marrero, Louisiana, 70072

  • Genoma Research Group, Inc. ( Site 2669)

    Miami, Florida, 33173

  • Floridian Clinical Research, LLC ( Site 2656)

    Miami Lakes, Florida, 33016-1518

  • Ocean Blue Medical Research Center Inc ( Site 2667)

    Miami Springs, Florida, 33166

  • Catalina Research Institute, LLC ( Site 2643)

    Montclair, California, 91763

  • NYU Langone Health, New York ( Site 2627)

    New York, New York, 10016

  • Arkansas Gastroenterology - North Little Rock ( Site 9015)

    North Little Rock, Arkansas, 72117

  • Sensible Healthcare Llc ( Site 2607)

    Ocoee, Florida, 34761

  • Synexus Research ( Site 2672)

    Orlando, Florida, 32806

  • Velocity Clinical Research, Panorama City ( Site 9001)

    Panorama City, California, 91402

  • California Liver Research Institute ( Site 9025)

    Pasadena, California, 91105

  • Virginia Commonwealth University Health System ( Site 2657)

    Richmond, Virginia, 23298

  • Quality Research ( Site 9024)

    San Antonio, Texas, 78209

  • American Research Corporation at Texas Liver Institute ( Site 2634)

    San Antonio, Texas, 78215

  • Clinical Trials of Texas, LLC ( Site 2614)

    San Antonio, Texas, 78229

  • Quest Clinical Research ( Site 9011)

    San Francisco, California, 94115

  • Velocity Clinical Research, Santa Ana ( Site 9002)

    Santa Ana, California, 92704

  • Adobe Clinical Research, LLC ( Site 2644)

    Tucson, Arizona, 85712

  • Arizona Liver Health ( Site 9026)

    Tucson, Arizona, 85712

  • Del Sol Research Management ( Site 2674)

    Tucson, Arizona, 85715

  • Impact Research Institute ( Site 2685)

    Waco, Texas, 76710

  • Regional Gastroenterology Associates of Lancaster, LTD ( Site 9004)

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Japan19 sites

  • Fukui-ken Saiseikai Hospital ( Site 1410)

    Fukui, 918-8503

  • Gifu Municipal Hospital ( Site 1408)

    Gifu, 500-8513

  • Hiroshima University Hospital ( Site 1413)

    Hiroshima, 7348551

  • Kagoshima University Hospital ( Site 1418)

    Kagoshima, 890-8520

  • Kanazawa University Hospital ( Site 1419)

    Kanazawa, Ishikawa-ken, 920-8641

  • Nara Medical University Hospital ( Site 1407)

    Kashihara, Nara, 634-8522

  • Shinyurigaoka General Hospital ( Site 1420)

    Kawasaki, Kanagawa, 215-0026

  • Kagawa University Hospital ( Site 1414)

    Kita-gun, Kagawa-ken, 761-0793

  • University Hospital, Kyoto Prefectural University of Medicine ( Site 1405)

    Kyoto, 602-8566

  • Aichi Medical University Hospital ( Site 1402)

    Nagakute, Aichi-ken, 480-1195

  • Ogaki Municipal Hospital ( Site 1409)

    Ōgaki, Gifu, 503-8502

  • Kawasaki Medical School General Medical Center ( Site 1412)

    Okayama, 700-8505

  • Osaka Metropolitan University Hospital ( Site 1415)

    Osaka, 545-8586

  • Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 1404)

    Sapporo, Hokkaido, 060-0033

  • Saiseikai Suita Hospital ( Site 1403)

    Suita, Osaka, 564-0013

  • Kagawa Prefectural Central Hospital-liver intemal medicine ( Site 1416)

    Takamatsu, Kagawa-ken, 760-0065

  • Toranomon Hospital ( Site 1401)

    Tokyo, 105-8470

  • Ehime University Hospital ( Site 1417)

    Tōon, Ehime, 791-0295

  • Yokohama City University Hospital ( Site 1411)

    Yokohama, Kanagawa, 236-0004

Other trials in Japan

France13 sites

  • CHU Besançon ( Site 0806)

    Besançon, Franche-Comte, 25000

  • Hôpital Beaujon ( Site 0804)

    Clichy, Hauts-de-Seine, 92110

  • Hopital Henri Mondor ( Site 0808)

    Créteil, Val-de-Marne, 94000

  • CHU Dijon Bourgogne - Hopital F. Mitterrand ( Site 0816)

    Dijon, Bourgogne-Franche-Comté, 21079

  • Hôpital Claude Huriez ( Site 0811)

    Lille, Nord, 59037

  • Centre Hospitalier et Universitaire Dupuytren ( Site 0810)

    Limoges, Haute-Vienne, 87042

  • Hopital de la Croix-Rousse ( Site 0809)

    Lyon, Auvergne, 69004

  • CHU de Nice Hopital de l Archet II ( Site 0800)

    Nice, Alpes-Maritimes, 06202

  • A.P.H. Paris, Hopital Saint Antoine ( Site 0807)

    Paris, 75012

  • Hopital de la Pitie Salpetriere ( Site 0813)

    Paris, 75013

  • Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0812)

    Paris, 75679

  • hopital haut leveque chu de bordeaux-Service d'Hépato-gastroentérologie ( Site 0805)

    Pessac, Aquitaine, 33600

  • C.H.U. Nancy Hopital de Brabois ( Site 0803)

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500

Other trials in France

Argentina9 sites

  • Hospital Británico de Buenos Aires ( Site 0002)

    Buenos Aires, Buenos Aires F.D., 1280

  • Glenny Corp. S.A.-CLINICAL RESEARCH ( Site 0013)

    Buenos Aires, Buenos Aires F.D., C1430CKE

  • Hospital Aleman ( Site 0009)

    Buenos Aires, C1118AAT

  • Hospital Italiano de Buenos Aires-Hepatology ( Site 0014)

    Ciudad de Buenos Aires, Buenos Aires F.D., C1199ABB

  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0010)

    Mar del Plata, Buenos Aires, 7600

  • Hospital Universitario Austral ( Site 0003)

    Pilar, Buenos Aires, B1629AHJ

  • DIM Clínica Privada ( Site 0011)

    Ramos Mejía, Buenos Aires, 1704

  • Hospital Provincial del Centenario ( Site 0007)

    Rosario, Santa Fe Province, S2002KDS

  • Clinica de nefrologia urologia y enfermedades cardiovasculares ( Site 0008)

    Santa Fe, S3000BPJ

Other trials in Argentina

Russia9 sites

  • City Clinical Hospital named V.M.Buyanova ( Site 1922)

    Moscow, Moscow, 115516

  • Russian University of People Friendship ( Site 1907)

    Moscow, Moscow, 117198

  • Nephrology Clinic of Internal and Prof. Diseases n.a.E.M.Tareev ( Site 1906)

    Moscow, Moscow, 119435

  • Center targetnoy therapy-Gastroenterology ( Site 1918)

    Moscow, Moscow, 125008

  • Medical Rehabilitation Center ( Site 1904)

    Moscow, Moscow, 125367

  • SPb State Budgetary Institution Health Care City Policlinic 17 ( Site 1910)

    Saint Petersburg, Sankt-Peterburg, 194358

  • Scientific research center ECO-security ( Site 1920)

    Saint Petersburg, Sankt-Peterburg, 196143

  • Surgical Clinic "Parada" ( Site 1921)

    Saint Petersburg, Sankt-Peterburg, 197348

  • LLC Astarta ( Site 1912)

    Saint Petersburg, Sankt-Peterburg, 199226

Other trials in Russia

South Korea9 sites

  • Pusan National University Hospital-Internal Medicine ( Site 2010)

    Busan, Pusan-Kwangyokshi, 49241

  • Chungang University Hospital ( Site 2007)

    Dongjak-gu, Seoul, 06973

  • Inha University Hospital-Gastroenterolgy/Hepatology ( Site 2006)

    Incheon, 22332

  • Seoul National University Bundang Hospital-Internal Medicine ( Site 2005)

    Seongnam, Kyonggi-do, 13620

  • Seoul National University Hospital ( Site 2003)

    Seoul, 03080

  • Hanyang University Seoul Hospital ( Site 2002)

    Seoul, 04763

  • Samsung Medical Center-Gastroenterology/Internal Medicine ( Site 2008)

    Seoul, 06351

  • Korea University Guro Hospital ( Site 2004)

    Seoul, 08308

  • Asan Medical Center ( Site 2001)

    Songpagu, Seoul, 05505

Other trials in South Korea

Israel7 sites

  • Rambam Medical Center ( Site 1201)

    Haifa, 3109601

  • Carmel Medical Center ( Site 1203)

    Haifa, 3436212

  • Shaare Zedek Medical Center ( Site 1205)

    Jerusalem, 9132201

  • Rabin Medical Center ( Site 1204)

    Petah Tikva, 4941492

  • Chaim Sheba Medical Center ( Site 1200)

    Ramat Gan, 5265601

  • Maccabi Health Services - Ramat Hasharon ( Site 1206)

    Ramat HaSharon, 4731001

  • Sourasky Medical Center ( Site 1202)

    Tel Aviv, 6423906

Other trials in Israel

Taiwan7 sites

  • Chiayi Christian Hospital ( Site 2308)

    Chiayi City, Chiayi, 600

  • Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 2302)

    Kaohsiung City, 807

  • Chung Shan Medical University Hospital ( Site 2307)

    Taichung, Taichung, 402

  • Taichung Veterans General Hospital ( Site 2306)

    Taichung, 407

  • National Cheng Kung University Hospital ( Site 2304)

    Tainan, 704

  • National Taiwan University Hospital ( Site 2301)

    Taipei, 100

  • Chang Gung Memorial Hospital - Linkou Branch ( Site 2305)

    Taoyuan County, Taoyuan, 333

Other trials in Taiwan

Turkey (Türkiye)7 sites

  • Hacettepe Uni. Ic Hastaliklari Anabilim Dali, Nefroloji BD ( Site 2403)

    Ankara, 06230

  • Gazi University Medical Faculty ( Site 2405)

    Ankara, 06560

  • Ankara University Cebeci Research and Application Hospital ( Site 2406)

    Ankara, 54290

  • Bezmialem Vakf Üniversitesi-Gastroenterology ( Site 2402)

    Istanbul, 34093

  • Istanbul Universitesi Tip Fakultesi Hastanesi ( Site 2401)

    Istanbul, 34093

  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 2400)

    Istanbul, 34899

  • Ege University Medical Faculty ( Site 2404)

    Izmir, 35100

Other trials in Turkey (Türkiye)

Chile6 sites

  • Hospital Regional de Concepcion ( Site 0505)

    Concepción, Biobio, 4070038

  • Hospital San Juan de Dios de La Serena ( Site 0500)

    La Serena, Coquimbo Region, 1710216

  • Enroll SpA ( Site 0508)

    Santiago, Region M. de Santiago, 7500587

  • Pontificia Universidad Catolica de Chile ( Site 0501)

    Santiago, Region M. de Santiago, 8330077

  • Clinical Research Chile SpA ( Site 0506)

    Valdivia, Los Ríos Region, 5110683

  • Centro de Investigaciones Clinicas Vina del Mar ( Site 0502)

    Viña del Mar, Valparaiso, 2540488

Other trials in Chile

China6 sites

  • Beijing YouAn Hospital, Capital Medical University ( Site 0605)

    Beijing, Beijing Municipality, 100069

  • The First People's Hospital of Foshan-Infection Department ( Site 0612)

    Foshan, Guangdong, 528041

  • The Affiliated Hospital of Hangzhou Normal University ( Site 0600)

    Hangzhou, Zhejiang, 310015

  • Xinhua Hospital Affiliated to Jiaotong University School of Medicine ( Site 0602)

    Shanghai, Shanghai Municipality, 200092

  • Chongqing Three Gorges Central Hospital ( Site 0618)

    Wanzhou District, Chongqing Municipality, 404100

  • General Hospital of Ningxia Medical University ( Site 0607)

    Yinchuan, Ningxia, 750004

Other trials in China

Spain6 sites

  • Hospital Universitari Vall d Hebron ( Site 2101)

    Barcelona, 08035

  • Hospital Clinic de Barcelona ( Site 2102)

    Barcelona, 08036

  • Hospital Universitario Puerta de Hierro-Majadahonda ( Site 2100)

    Majadahonda, Madrid, 28222

  • Hospital Universitario Marqués de Valdecilla-Gastroenterology and Hepatology ( Site 2106)

    Santander, Cantabria, 39005

  • Hospital Clinico Universitario de Santiago ( Site 2104)

    Santiago de Compostela, La Coruna, 15706

  • Hospital Universitario Virgen del Rocio ( Site 2105)

    Seville, Sevilla, 41013

Other trials in Spain

Germany5 sites

  • Charite Universitaetsmedizin Berlin ( Site 0443)

    Berlin, 13353

  • Universitätsklinikum Frankfurt-Medizinische Klinik 1 ( Site 0445)

    Frankfurt am Main, Hesse, 60590

  • Universitaetsklinikum Freiburg ( Site 0446)

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Universitaetsklinikum Leipzig ( Site 0447)

    Leipzig, Saxony, 04103

  • Johannes Gutenberg Universitat Mainz ( Site 0442)

    Mainz, Rhineland-Palatinate, 55131

Other trials in Germany

Mexico5 sites

  • Centro de Investigacion Medico Biologica y Terapia Avanzada SC ( Site 1511)

    Guadalajara, Jalisco, 44130

  • Medical Care and Research S.A. de C.V. ( Site 1506)

    Mérida, Yucatán, 97070

  • Medica Sur-Clinica de Enfermedades Digestivas y Obesidad ( Site 1515)

    Mexico City, Mexico City, 14050

  • Centro de Investigacion y Gastroenterologia SC ( Site 1503)

    Mexico City, 06700

  • Centro de Investigacion Medica de Occidente S.C. ( Site 1514)

    Zapopan, Jalisco, 45116

Other trials in Mexico

Italy4 sites

  • A O U Policlinico di Modena ( Site 1307)

    Modena, 41124

  • Azienda Ospedaliera Policlinico Umberto I ( Site 1300)

    Roma, 00161

  • IRCCS Istituto Clinico Humanitas di Rozzano ( Site 1303)

    Rozzano, Lombardy, 20089

  • Azienda Ospedaliera Universitaria Integrata Verona ( Site 1301)

    Verona, 37134

Other trials in Italy

Australia3 sites

  • Flinders Medical Centre ( Site 0107)

    Bedford Park, South Australia, 5042

  • Royal Prince Alfred Hospital ( Site 0102)

    Camperdown, New South Wales, 2050

  • St George Hospital ( Site 0104)

    Kogarah, New South Wales, 2217

Other trials in Australia

Canada3 sites

  • McGill University Health Centre ( Site 0400)

    Montreal, Quebec, H4A 3J1

  • University Health Network - Toronto General Hospital ( Site 0401)

    Toronto, Ontario, M5G 2C4

  • GIRI GI Research Institute - Vancouver ( Site 0404)

    Vancouver, British Columbia, V5Z 2K5

Other trials in Canada

Hong Kong3 sites

  • Queen Mary Hospital ( Site 1003)

    Hong Kong, 000000

  • Prince of Wales Hospital ( Site 1001)

    Shatin

  • Prince of Wales Hospital ( Site 1002)

    Shatin

Other trials in Hong Kong

New Zealand3 sites

  • Auckland Clinical Studies Limited ( Site 1600)

    Auckland, 1010

  • Middlemore Clinical Trials ( Site 1601)

    Auckland, 2025

  • Christchurch Hospital ( Site 1602)

    Christchurch, Canterbury, 8011

Other trials in New Zealand

Puerto Rico3 sites

  • Pan American Center for Oncology Trials ( Site 3102)

    Rio Piedras, 00935

  • Klinical Investigations Group ( Site 3100)

    San Juan, 00909

  • FDI Clinical Research ( Site 3101)

    San Juan, 00927

Other trials in Puerto Rico

Sweden2 sites

  • Karolinska Universitetssjukhuset Huddinge ( Site 2900)

    Huddinge, Stockholm County, 141 86

  • Akademiska sjukhuset ( Site 2901)

    Uppsala, Uppsala County, 751 85

Other trials in Sweden

Colombia1 site

  • Fundacion Santa Fe de Bogota ( Site 0705)

    Bogotá, Bogota D.C., 110111

Other trials in Colombia

Greece1 site

  • Hippokration University Hopsital-4th Department of Internal Medicine ( Site 3300)

    Thessaloniki, Central Macedonia, 5 46 42

Other trials in Greece

Malaysia1 site

  • Hospital Kuala Lumpur-Gastroenterology Department ( Site 2701)

    Kuala Lumpur, 50586

Other trials in Malaysia

About this study

Official title: A Phase 2b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis.

This study will evaluate the effect of each dose of MK-3655 versus placebo on the percentage of individuals with NASH resolution without worsening of fibrosis after 52 weeks. The primary hypothesis of the study is that at least 1 dose of MK-3655 is superior to placebo with respect to the percentage of individuals with NASH resolution without worsening of fibrosis after 52 weeks.

Being tested
MK-3655, Placebo
Keywords
Non-alcoholic fatty liver disease
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.

  • MK-3655Drug

    Also called NGM313

    MK-3655 50, 100 or 300 dose for injection

  • PlaceboDrug

    Matching placebo to MK-3655

Study groups in NCT04583423
Study groupRoleWhat they receive
MK-3655 50 mgExperimentalFollowing a 2-week placebo run-in, participants will receive MK-3655 50 mg by subcutaneous (SC) injection once every 4 weeks (Q4W) for 52 weeks.
Receives: Drug: MK-3655
MK-3655 100 mgExperimentalFollowing a 2-week placebo run-in, participants will receive MK-3655 100 mg by SC injection Q4W for 52 weeks.
Receives: Drug: MK-3655
MK-3655 300 mgExperimentalFollowing a 2-week placebo run-in, participants will receive MK-3655 300 mg by SC injection Q4W for 52 weeks.
Receives: Drug: MK-3655
PlaceboPlacebo comparatorFollowing a 2-week placebo run-in, participants will receive Placebo by SC injection Q4W for 52 weeks.
Receives: Drug: Placebo

What is being measured

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

  1. Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 52 Weeks

    The NASH Clinical Research Network (CRN) scoring system evaluated by Blinded Independent Central Review (BICR) was used to assess treatment response. The NASH CRN scoring scales were: lobular inflammation score (0-3); hepatocyte ballooning score (0-2); steatosis score (0-3); and fibrosis score (0-4). NASH resolution was defined as a score of 0-1 for inflammation, 0 for ballooning, and any grade of steatosis.

    Measured: Week 52

  2. Percentage of Participants Who Experienced an Adverse Event (AE)

    An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.

    Measured: Up to 64 weeks

  3. Percentage of Participants Discontinuing Study Medication Due to an AE

    An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.

    Measured: Up to 52 weeks

Secondary outcomes (3)

  1. Mean Percent Relative Reduction From Baseline in Liver Fat Content (LFC) After 24 Weeks

    LFC % was measured by Magnetic Resonance Imaging-Estimated Proton Density Fat Fraction (MRI-PDFF) and evaluated by BICR. MRI-PDFF is a highly accurate noninvasive measure of the proportion of fat content of a tissue.

    Measured: Baseline and Week 24

  2. Percentage of Participants With ≥1 Stage Improvement in Fibrosis Without Worsening of Steatohepatitis Assessed With the NASH CRN Scoring System After 52 Weeks

    Participants were evaluated with the NASH CRN scoring system with BICR with ≥1 stage improvement in fibrosis without worsening of steatohepatitis defined as no increase in the ballooning, inflammation, or steatosis scores.

    Measured: Week 52

  3. Percentage of Participants With ≥2 Point Improvement in NAS With ≥1 Point Improvement in Inflammation or Ballooning Without Worsening of Fbrosis by Histology (Evaluated by BICR) After 52 Weeks

    Participants with ≥2 point improvement in the NAS with ≥1 point improvement in inflammation or ballooning without worsening of fibrosis were assessed with the NASH CRN scoring system (evaluated by BICR). The NAS was calculated as the unweighted sum of the scores and ranges from 0-8 (highest activity).

    Measured: Week 52

Timeline

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

  1. First posted12 Oct 2020
  2. Study start11 Nov 2020
  3. Primary completion13 Apr 2023
  4. Study completion13 Apr 2023

Why it stopped: Business reasons

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
183 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04583423
Sponsor's protocol ID
3655-001
Other IDs
MK-3655-001, jRCT2051200083, 2019-003048-63, 2019
Status last verified
Jul 2025
First submitted
5 Oct 2020
Last updated
17 Jul 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • Raji A, Gantz I, Crutchlow M, Flynn H, Xu L, Rodgers AJ, Krishnan R, Rizk ML, Hu S, Kaufman KD, Engel SS; MK-3655 P001 Study Group. Clinical Trial: A Phase 2b Study to Evaluate the Efficacy and Safety of MK-3655 in Individuals With Pre-Cirrhotic MASH. Aliment Pharmacol Ther. 2025 Apr;61(7):1152-1162. doi: 10.1111/apt.70038. Epub 2025 Feb 21.

    PubMed 39984821

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MK-3655 in people with Nonalcoholic Steatohepatitis, run by Merck Sharp & Dohme LLC at 180 sites in 24 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 6 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: stopped early, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 180 sites in United States, Japan, France, Argentina, Russia and 19 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 29 Apr 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?

Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 52 Weeks (time frame: Week 52). The study lists 3 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 NCT04583423, 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 17 Jul 2025.

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