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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-002723-11 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Survodutide 2.4 mg - planned maintenance treatment | Experimental |
| |
| Survodutide 4.8 mg - planned maintenance treatment | Experimental |
| |
| Survodutide 6.0 mg - planned maintenance treatment | Experimental |
| |
| Placebo - planned maintenance treatment | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Survodutide | Drug | Survodutide |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline and at 48 weeks. |
| 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. | At baseline and after 48 weeks of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Further inclusion criteria apply.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Alabama Health Research, LLC | Huntsville | Alabama | 35801 | United States | ||
| Southern California Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38847460 | Derived | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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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.
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
All subjects were screened for eligibility prior to participation in the trial. Patients who met the eligibility criteria at an initial screening visit had a second screening visit for biopsy to confirm their eligibility, if no sufficient material from a historical biopsy within the 6 months prior to randomisation was available.
This was a 48 weeks, multi-centre, randomised, dose-ranging, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy, safety and tolerability of multiple subcutaneous (s.c.) doses of survodutide (BI 456906) in patients with non-alcoholic steatohepatitis (NASH).
Main parameters for inclusion of patients and for evaluation of treatment response were based on the histological evaluation from the liver biopsy and non-invasive imaging modalities.
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| ID | Title | Description |
|---|---|---|
| FG000 | Survodutide 2.4 mg - Planned Maintenance Treatment | Patients with non-alcoholic steatohepatitis (NASH) with non-alcoholic fatty liver disease (NAFLD) activity score (NAS) ≥4 and fibrosis stage 1-3 (F1-F3). were to be administered once weekly, subcutaneously a solution for injection of survodutide at a starting dose of 0.3 milligrams (mg) followed by a dose escalation up to the maintenance dose of 2.4 mg of survodutide. The total treatment duration was 48 weeks (consisting of up to 24 weeks dose escalation period and at least 24 weeks maintenance period). Participants not tolerating the assigned dose due to gastrointestinal adverse events had the option of a dose adjustment which could lead to a maintenance dose lower than the dose the patient was randomized to. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Dose Escalation Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 27, 2023 | Nov 6, 2024 |
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|
| Placebo | Drug | Placebo |
|
| At baseline and after 48 weeks. |
| 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. | At baseline and at 48 weeks. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| 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:
| At baseline and after 48 weeks of treatment. |
| 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:
| At baseline and after 48 weeks of treatment. |
| 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. | At baseline and 48 weeks of treatment. |
| 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. | At baseline and 48 weeks of treatment. |
| Coronado |
| California |
| 92118 |
| United States |
| Velocity Clinical Research | Huntington Park | California | 90255 | United States |
| Velocity Clinical Research | Panorama City | California | 91402 | United States |
| Quest Clinical Research | San Francisco | California | 94115 | United States |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80907 | United States |
| Integrity Clinical Research, LLC | Doral | Florida | 33166 | United States |
| Covenant Metabolic Specialists, LLC | Fort Myers | Florida | 33912 | United States |
| Optimus U Corporation | Miami | Florida | 33135 | United States |
| Sanchez Clinical Research ,Inc | Miami | Florida | 33157 | United States |
| Ocala GI Research | Ocala | Florida | 34471 | United States |
| Omega Research Orlando, LLC | Orlando | Florida | 32808 | United States |
| Covenant Metabolic Specialists, LLC | Sarasota | Florida | 34240 | United States |
| Gastrointestinal Specialists of Georgia | Marietta | Georgia | 30060 | United States |
| Digestive Research Alliance of Michiana | South Bend | Indiana | 46635 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Delta Research Partners, LLC | Bastrop | Louisiana | 71220 | United States |
| Centex Studies, Inc. | Lake Charles | Louisiana | 70601 | United States |
| Tandem Clinical Research | Marrero | Louisiana | 70072 | United States |
| NECCR PrimaCare Research, LLC | Fall River | Massachusetts | 02721 | United States |
| National Diabetes and Obesity Research Institute | Biloxi | Mississippi | 39532 | United States |
| Gastrointestinal Associates | Flowood | Mississippi | 39232 | United States |
| AIG Digestive Disease Research | Florham Park | New Jersey | 07932 | United States |
| Northeast GI Research Division | Concord | North Carolina | 28027 | United States |
| Lucas Research, Inc. | Morehead City | North Carolina | 28557 | United States |
| Digestive Diseases Research Center | Greenwood | South Carolina | 29646 | United States |
| Palmetto Clinical Research | Summerville | South Carolina | 29485 | United States |
| Digestive Health Research, LLC | Hermitage | Tennessee | 37076 | United States |
| Texas Clinical Research Institute, LLC | Arlington | Texas | 76012 | United States |
| Texas Liver Institute | Austin | Texas | 78757 | United States |
| South Texas Research Institute | Brownsville | Texas | 78520 | United States |
| South Texas Research Institute | Edinburg | Texas | 78539 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| American Research Corporation at the Texas Liver Institute | San Antonio | Texas | 78215 | United States |
| Pinnacle Clinical Research | San Antonio | Texas | 78229 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Gold Coast University Hospital | Southport | Queensland | 4215 | Australia |
| Monash Medical Centre | Clayton | Victoria | 3168 | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| Medical University of Graz State Hospital - University Hospital Graz | Graz | 8036 | Austria |
| Medical University of Innsbruck | Innsbruck | A-6020 | Austria |
| Ordensklinikum Linz GmbH - Barmherzige Schwestern | Linz | A-4010 | Austria |
| Edegem - UNIV UZ Antwerpen | Edegem | 2650 | Belgium |
| University Hospital (LHSC) | London | Ontario | N6A 5A5 | Canada |
| Toronto Liver Centre | Toronto | Ontario | M6H 3M1 | Canada |
| Ecogene-21 | Chicoutimi | Quebec | G7H 7K9 | Canada |
| Beijing Ditan Hospital Capital Medical University | Beijing | 100015 | China |
| Beijing Tsinghua Changgung Hospital | Beijing | 100044 | China |
| Peking University People's Hospital | Beijing | 100044 | China |
| Beijing Friendship Hospital | Beijing | 100050 | China |
| The First Hospital of Jilin University | Changchun | 130021 | China |
| The First Afiliated Hospital, Sun Yet-sen University | Guangzhou | 510080 | China |
| NanFang Hosptial | Guangzhou | 510515 | China |
| Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine | Hangzhou | 310016 | China |
| First People's hospital of Yunann Province | Kunming | 650032 | China |
| The Second Hospital of Nanjing | Nanjing | 210003 | China |
| Shanghai Public Health Clinical Center | Shanghai | 201508 | China |
| Tianjin Third Central Hospital | Tianjin | 300170 | China |
| The First Affiliated Hospital of Wenzhou Med College | Wenxzhou | 325000 | China |
| Regional Hospital Liberec | Liberec | 460 63 | Czechia |
| General Faculty Hospital, Prague | Prague | 128 08 | Czechia |
| HOP l'Archet | Nice | 06200 | France |
| HOP La Pitié Salpêtrière | Paris | 75651 | France |
| HOP Haut-Lévêque | Pessac | 33604 | France |
| HOP Civil | Strasbourg | 67091 | France |
| Universitätsklinikum Aachen, AöR | Aachen | 52074 | Germany |
| Synexus Clinical Research GmbH | Berlin | 12627 | Germany |
| Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH | Bochum | 44892 | Germany |
| Universitätsklinikum Düsseldorf | Düsseldorf | 40225 | Germany |
| Synexus Clinical Research GmbH | Frankfurt | 60313 | Germany |
| Synexus Clinical Research GmbH | Leipzig | 04103 | Germany |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz | Mainz | 55131 | Germany |
| Universitätsklinikum Mannheim GmbH | Mannheim | 68167 | Germany |
| Universitätsklinikum Ulm | Ulm | 89081 | Germany |
| Attikon University Hospital | Haidari-Athens | 12462 | Greece |
| General Hospital of Thessaloniki "Hippokrateio" | Thessaloniki | 54642 | Greece |
| Prince of Wales Hospital | Hong Kong | 999077 | Hong Kong |
| Queen Mary Hospital | Hong Kong | 999077 | Hong Kong |
| Synexus Hungary Healthcare Service Ltd. | Budapest | 1036 | Hungary |
| Fed.St. Istvan&Szent Laszlo Hospital | Budapest | 1097 | Hungary |
| Synexus Hungary Healthcare Service Ltd | Gyula | 5700 | Hungary |
| Shaare Zedek Medical Center, Jerusalem 91031 | Jerusalem | 9103102 | Israel |
| Western Galilee Hospital | Nahariya | 22100 | Israel |
| Rabin Medical Center Beilinson | Petah Tikva | 49100 | Israel |
| Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| The Chaim Sheba Medical Center | Tel Litwinsky | 5265601 | Israel |
| Ospedale Civile di Baggiovara | Baggiovara (MO) | 41126 | Italy |
| A.O. Univ. Policlinico "Paolo Giaccone" | Palermo | 90127 | Italy |
| Poli Univ A. Gemelli | Roma | 00195 | Italy |
| Istituto Clinico Humanitas | Rozzano (MI) | 20089 | Italy |
| IRCCS Ospedale "Casa Sollievo della Sofferenza" | SAN Giovanni Rotondo (FG) | 71013 | Italy |
| AO Città della Salute e Scienza | Torino | 10126 | Italy |
| Ehime University Hospital | Ehime, Toon | 791-0295 | Japan |
| Fukuiken Saiseikai Hospital | Fukui, Fukui | 918-8503 | Japan |
| Kurume University Hospital | Fukuoka, Kurume | 830-0011 | Japan |
| Ogaki Municipal Hospital | Gifu, Ogaki | 503-8502 | Japan |
| Japan Community Health Care Organization Hokkaido Hospital | Hokkaido, Sapporo | 062-8618 | Japan |
| Kagawa University Hospital | Kagawa, Kita-gun | 761-0793 | Japan |
| Kagawa Prefectural Central Hospital | Kagawa, Takamatsu | 760-8557 | Japan |
| St. Marianna University Hospital | Kanagawa, Kawasaki | 216-8511 | Japan |
| Kitasato University Hospital | Kanagawa, Sagamihara | 252-0375 | Japan |
| Yokohama City University Hospital | Kanagawa, Yokohama | 236-0004 | Japan |
| National Hospital Organization Yokohama Medical Center | Kanagawa, Yokohama | 245-8575 | Japan |
| Kumamoto University Hospital | Kumamoto, Kumamoto | 860-8556 | Japan |
| University Hospital Kyoto Prefectural University of Medicine | Kyoto, Kyoto | 602-8566 | Japan |
| Shinshu University Hospital | Nagano, Matsumoto | 390-8621 | Japan |
| Nagano Municipal Hospital | Nagano, Nagano | 381-8551 | Japan |
| Nara Medical University Hospital | Nara, Kashihara | 634-8522 | Japan |
| Suita Hospital | Osaka, Suita | 564-0013 | Japan |
| Saga University Hospital | Saga, Saga | 849-8501 | Japan |
| Hamamatsu University Hospital | Shizuoka, Hamamatsu | 431-3192 | Japan |
| Juntendo University Shizuoka Hospital | Shizuoka, Izunokuni | 410-2295 | Japan |
| Tokyo Medical and Dental University Hospital | Tokyo, Bunkyo-ku | 113-8519 | Japan |
| Universiti Sains Malaysia Hospital | Kelantan | 16150 | Malaysia |
| University of Malaya Medical Centre | Kuala Lumpur | 59100 | Malaysia |
| Hospital Selayang | Kuala Selangor | 68100 | Malaysia |
| Amsterdam UMC, location VUMC | Amsterdam | 1105 AZ | Netherlands |
| Leids Universitair Medisch Centrum (LUMC) | Leiden | 2333 ZA | Netherlands |
| Sint Franciscus, Locatie Vlietland | Rotterdam | 3045 PM | Netherlands |
| New Zealand Clinical Research (NZCR) | Auckland | 1010 | New Zealand |
| Middlemore Clinical Trials | Papatoetoe | 2025 | New Zealand |
| INTERCORE Medical Center | Bydgoszcz | 85-605 | Poland |
| Synexus Poland, Branch in Czestochowa | Częstochowa | 42202 | Poland |
| Private health care facility "Your Health EL" LLC | Elblag | 82-300 | Poland |
| Synexus Polska SCM Sp. z o.o. Gdansku, Gdansk | Gdansk | 80-382 | Poland |
| Synexus Polska Sp. z o.o. Oddzial w Gdyni, Gdynia | Gdynia | 81-384 | Poland |
| University Clinical Center Professor Gibinskiego | Katowice | 40-752 | Poland |
| University Hospital in Krakow | Krakow | 30688 | Poland |
| Medicome Limited Liability Company | Oświęcim | 32600 | Poland |
| Centrum Medyczne Synexus | Warsaw | 01-192 | Poland |
| Synexus Poland, Branch in Wroclaw | Wroclaw | 50-088 | Poland |
| ETG Zamosc | Zamość | 22400 | Poland |
| ULS de Santa Maria, E.P.E | Lisbon | 1649-035 | Portugal |
| Centro Hospitalar Universitário São João,EPE | Porto | 4202-451 | Portugal |
| National University Hospital | Singapore | 119074 | Singapore |
| Singapore General Hospital | Singapore | 168753 | Singapore |
| Pusan National Univ. Hosp | Busan | 49241 | South Korea |
| Keimyung University Dongsan Hospital | Daegu | 42601 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Puerta de Hierro | Majadahonda | 28222 | Spain |
| Hospital de Montecelo | Pontevedra | 36071 | Spain |
| Hospital Universitario Marqués de Valdecilla | Santander | 39008 | Spain |
| Hospital Virgen del Rocío | Seville | 41013 | Spain |
| Hospital General Universitario de Valencia | Valencia | 46014 | Spain |
| Chia Yi Christian Hospital | Chiayi City | 60002 | Taiwan |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | 807 | Taiwan |
| National Chen Kung University, Dept of Neurology | Tainan | 704 | Taiwan |
| Chang Gung Memorial Hospital(Linkou) | Taoyuan County | 333 | Taiwan |
| Queen Elizabeth Hospital | Birmingham | B15 2TH | United Kingdom |
| Synexus - Hexham | Hexham | NE46 1QJ | United Kingdom |
| Aintree University Hospital | Liverpool | L9 7AL | United Kingdom |
| King's College Hospital | London | SE5 9RS | United Kingdom |
| Queen's Medical Centre | Nottingham | NG7 2RD | United Kingdom |
| FG001 | Survodutide 4.8 mg - Planned Maintenance Treatment | Patients with non-alcoholic steatohepatitis (NASH) with non-alcoholic fatty liver disease (NAFLD) activity score (NAS) ≥4 and fibrosis stage 1-3 (F1-F3). were to be administered once weekly, subcutaneously a solution for injection of survodutide at a starting dose of 0.3 milligrams (mg) followed by a dose escalation up to the maintenance dose of 4.8 mg of survodutide. The total treatment duration was 48 weeks (consisting of up to 24 weeks dose escalation period and at least 24 weeks maintenance period). Participants not tolerating the assigned dose due to gastrointestinal adverse events had the option of a dose adjustment which could lead to a maintenance dose lower than the dose the patient was randomized to. |
| FG002 | Survodutide 6.0 mg - Planned Maintenance Treatment | Patients with non-alcoholic steatohepatitis (NASH) with non-alcoholic fatty liver disease (NAFLD) activity score (NAS) ≥4 and fibrosis stage 1-3 (F1-F3). were to be administered once weekly, subcutaneously a solution for injection of survodutide at a starting dose of 0.3 milligrams (mg) followed by a dose escalation up to the maintenance dose of 6.0 mg of survodutide. The total treatment duration was 48 weeks (consisting of up to 24 weeks dose escalation period and at least 24 weeks maintenance period). Participants not tolerating the assigned dose due to gastrointestinal adverse events had the option of a dose adjustment which could lead to a maintenance dose lower than the dose the patient was randomized to. |
| FG003 | Placebo - Planned Maintenance Treatment | Patients with non-alcoholic steatohepatitis (NASH) with non-alcoholic fatty liver disease (NAFLD) activity score (NAS) ≥4 and fibrosis stage 1-3 (F1-F3). were administered once weekly, subcutaneously a solution for injection of placebo matching survodutide. The total treatment duration was 48 weeks (consisting of up to 24 weeks dose escalation period and at least 24 weeks maintenance period). |
|
| Treated With Trial Medication |
|
| COMPLETED | Completed treatment with trial medication |
|
| NOT COMPLETED |
|
|
| Maintenance Period |
|
|
Treated set - planned maintenance treatment: included all patients that were administered survodutide or placebo matching survodutide. Patients are analyzed according to the planned treatment (planned maintenance dose strength) they were assigned at randomisation even if patients did not reach the maintenance period at all, and therefore did not "settle" on any maintenance dose.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Survodutide 2.4 mg - Planned Maintenance Treatment | Patients with non-alcoholic steatohepatitis (NASH) with non-alcoholic fatty liver disease (NAFLD) activity score (NAS) ≥4 and fibrosis stage 1-3 (F1-F3). were to be administered once weekly, subcutaneously a solution for injection of survodutide at a starting dose of 0.3 milligrams (mg) followed by a dose escalation up to the maintenance dose of 2.4 mg of survodutide. The total treatment duration was 48 weeks (consisting of up to 24 weeks dose escalation period and at least 24 weeks maintenance period). Participants not tolerating the assigned dose due to gastrointestinal adverse events had the option of a dose adjustment which could lead to a maintenance dose lower than the dose the patient was randomized to. |
| BG001 | Survodutide 4.8 mg - Planned Maintenance Treatment | Patients with non-alcoholic steatohepatitis (NASH) with non-alcoholic fatty liver disease (NAFLD) activity score (NAS) ≥4 and fibrosis stage 1-3 (F1-F3). were to be administered once weekly, subcutaneously a solution for injection of survodutide at a starting dose of 0.3 milligrams (mg) followed by a dose escalation up to the maintenance dose of 4.8 mg of survodutide. The total treatment duration was 48 weeks (consisting of up to 24 weeks dose escalation period and at least 24 weeks maintenance period). Participants not tolerating the assigned dose due to gastrointestinal adverse events had the option of a dose adjustment which could lead to a maintenance dose lower than the dose the patient was randomized to. |
| BG002 | Survodutide 6.0 mg - Planned Maintenance Treatment | Patients with non-alcoholic steatohepatitis (NASH) with non-alcoholic fatty liver disease (NAFLD) activity score (NAS) ≥4 and fibrosis stage 1-3 (F1-F3). were to be administered once weekly, subcutaneously a solution for injection of survodutide at a starting dose of 0.3 milligrams (mg) followed by a dose escalation up to the maintenance dose of 6.0 mg of survodutide. The total treatment duration was 48 weeks (consisting of up to 24 weeks dose escalation period and at least 24 weeks maintenance period). Participants not tolerating the assigned dose due to gastrointestinal adverse events had the option of a dose adjustment which could lead to a maintenance dose lower than the dose the patient was randomized to. |
| BG003 | Placebo - Planned Maintenance Treatment | Patients with non-alcoholic steatohepatitis (NASH) with non-alcoholic fatty liver disease (NAFLD) activity score (NAS) ≥4 and fibrosis stage 1-3 (F1-F3). were administered once weekly, subcutaneously a solution for injection of placebo matching survodutide. The total treatment duration was 48 weeks (consisting of up to 24 weeks dose escalation period and at least 24 weeks maintenance period). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| NAS score at baseline | 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. | Mean | Standard Deviation | score on a scale |
| ||||||||||||||
| Number of participants at each category of liver fibrosis stage at baseline | Number of participants at each category of liver fibrosis stage at baseline is reported. 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:
| Count of Participants | Participants |
| |||||||||||||||
| Number of participants in each category of diabetes at baseline | Number of participants at each category of diabetes at baseline is reported. The reported categories of diabetes stratification are the following: Yes, No. | Count of Participants | Participants |
| |||||||||||||||
| Number of patients in each category of NAS score | Number of patients in each category of non-alcoholic fatty liver disease (NAFLD) activity score (NAS) score is reported. 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 reported categories of NAS score range are: 0; 1; 2; 3; 4; 5; 6; 7; 8. | Count of Participants | Participants |
| |||||||||||||||
| Number of patients in each category of the NAS sub-scores (steatosis and lobular inflammation) | 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. Number of patients in each category of the score range for steatosis and lobular inflammation is reported. | Count of Participants | Participants |
| |||||||||||||||
| Number of patients in each category of the NAS sub-scores (ballooning) | 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. Number of patients in each category of the score range for ballooning is reported. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Treated set - actual maintenance treatment. Patients are analyzed according to the actual treatment they received at the start of the dose maintenance period (for patients who reached the maintenance period) or the next maintenance dose up from the dose at treatment discontinuation (for patients who discontinued treatment prior to the maintenance period). | Posted | Number | Percentage of participants | At baseline and at 48 weeks. |
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| Primary | 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. | Treated set - planned maintenance treatment: included all patients that were administered survodutide or placebo matching survodutide. Patients are analyzed for this endpoint according to the planned treatment (planned maintenance dose strength) they were assigned at randomisation even if patients did not reach the maintenance period at all, and therefore did not "settle" on any maintenance dose. | Posted | Number | percentage of participants | At baseline and after 48 weeks of treatment. |
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| Secondary | 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. | Treated set - actual maintenance treatment. Patients are analyzed according to the actual treatment they received at the start of the dose maintenance period (for patients who reached the maintenance period) or the next maintenance dose up from the dose at treatment discontinuation (for patients who discontinued treatment prior to the maintenance period). | Posted | Number | Percentage of participants | At baseline and after 48 weeks. |
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| Secondary | 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. | Treated set - planned maintenance treatment: included all patients that were administered survodutide or placebo matching survodutide. Patients are analyzed for this endpoint according to the planned treatment (planned maintenance dose strength) they were assigned at randomisation even if patients did not reach the maintenance period at all, and therefore did not "settle" on any maintenance dose. | Posted | Number | Percentage of participants | At baseline and at 48 weeks. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Treated set - actual maintenance treatment. Patients are analyzed according to the actual treatment they received at the start of the dose maintenance period (for patients who reached the maintenance period) or the next maintenance dose up from the dose at treatment discontinuation (for patients who discontinued treatment prior to the maintenance period). The reported number of participants analyzed reflects the number of participants in the analysis model. | Posted | Least Squares Mean | 95% Confidence Interval | percentage of liver fat content | 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. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Treated set - planned maintenance treatment. Patients are analyzed for this endpoint according to the planned treatment (planned maintenance dose strength) they were assigned at randomisation even if patients did not reach the maintenance period at all, and therefore did not "settle" on any maintenance dose. The reported number of participants analyzed reflects the number of participants in the analysis model. | Posted | Least Squares Mean | 95% Confidence Interval | percentage of liver fat content | 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. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Treated set - actual maintenance treatment. Patients are analyzed according to the actual treatment they received at the start of the dose maintenance period (for patients who reached the maintenance period) or the next maintenance dose up from the dose at treatment discontinuation (for patients who discontinued treatment prior to the maintenance period). The reported number of participants analyzed reflects the number of participants in the analysis model. | Posted | Least Squares Mean | 95% Confidence Interval | percent change of liver fat content | 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. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Treated set - planned maintenance treatment: all patients that administered survodutide or placebo matching survodutide. Patients are analyzed for this endpoint according to the planned treatment (planned maintenance dose strength) they were assigned at randomisation even if patients did not reach the maintenance period at all, and therefore did not "settle" on any maintenance dose. The reported number of participants analyzed reflects the number of participants in the analysis model. | Posted | Least Squares Mean | 95% Confidence Interval | percent change of liver fat content | 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. |
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| Secondary | 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:
| Treated set - actual maintenance treatment. Patients are analyzed according to the actual treatment they received at the start of the dose maintenance period (for patients who reached the maintenance period) or the next maintenance dose up from the dose at treatment discontinuation (for patients who discontinued treatment prior to the maintenance period). | Posted | Number | Percentage of participants | At baseline and after 48 weeks of treatment. |
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| Secondary | 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:
| Treated set - planned maintenance treatment: included all patients that were administered survodutide or placebo matching survodutide. Patients are analyzed for this endpoint according to the planned treatment (planned maintenance dose strength) they were assigned at randomisation even if patients did not reach the maintenance period at all, and therefore did not "settle" on any maintenance dose. | Posted | Number | Percentage of participants | At baseline and after 48 weeks of treatment. |
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| Secondary | 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. | Treated set - actual maintenance treatment. Patients are analyzed according to the actual treatment they received at the start of the dose maintenance period (for patients who reached the maintenance period) or the next maintenance dose up from the dose at treatment discontinuation (for patients who discontinued treatment prior to the maintenance period). Only patients with NAS data at baseline and at 48 weeks after treatment are reported. | Posted | Mean | Standard Deviation | units on a scale | At baseline and 48 weeks of treatment. |
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| Secondary | 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. | Treated set - planned maintenance treatment: included all patients that were administered survodutide or placebo matching survodutide. Patients are analyzed for this endpoint according to the planned treatment (planned maintenance dose strength) they were assigned at randomisation even if patients did not reach the maintenance period at all, and therefore did not "settle" on any maintenance dose. Only patients with NAS data at baseline and at 48 weeks after treatment are reported. | Posted | Mean | Standard Deviation | units on a scale | At baseline and 48 weeks of treatment. |
|
[All-Cause Mortality], [Serious Adverse Events], [Other Adverse Events]: From first study drug administration until last study drug administration plus 28 days of residual effect period (REP), up to 365 days.
Treated set - actual maintenance treatment: included all patients that were administered survodutide or placebo matching survodutide. Patients are analyzed according to the actual treatment they received at the start of the dose maintenance phase (for patients who reached the maintenance period) or the next maintenance dose up from the dose at treatment discontinuation (for patients who discontinued treatment prior to the maintenance period).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Survodutide 2.4 mg - Actual Maintenance Treatment | This arm includes patients who were treated with 2.4 mg of survodutide administered weekly at the start of the maintenance period, for patients who reached the maintenance period, regardless of whether this was the randomised (planned) dose or not, and regardless of whether the patient stayed on that dose throughout the maintenance period. This arm includes also those patients for whom the next maintenance dose up from the dose at treatment discontinuation was 2.4 mg of survodutide administered weekly, for patients who discontinued treatment prior to the maintenance period, regardless of the reason for the treatment discontinuation. | 0 | 93 | 5 | 93 | 85 | 93 |
| EG001 | Survodutide 4.8 mg - Actual Maintenance Treatment | This arm includes patients who were treated with 4.8 mg of survodutide administered weekly at the start of the maintenance period, for patients who reached the maintenance period, regardless of whether this was the randomised (planned) dose or not, and regardless of whether the patient stayed on that dose throughout the maintenance period. This arm includes also those patients for whom the next maintenance dose up from the dose at treatment discontinuation was 4.8 mg of survodutide administered weekly, for patients who discontinued treatment prior to the maintenance period, regardless of the reason for the treatment discontinuation. | 0 | 69 | 7 | 69 | 60 | 69 |
| EG002 | Survodutide 6.0 mg - Actual Maintenance Treatment | This arm includes patients who were treated with 6.0 mg of survodutide administered weekly at the start of the maintenance period, for patients who reached the maintenance period, regardless of whether this was the randomised (planned) dose or not, and regardless of whether the patient stayed on that dose throughout the maintenance period. This arm includes also those patients for whom the next maintenance dose up from the dose at treatment discontinuation was 6.0 mg of survodutide administered weekly, for patients who discontinued treatment prior to the maintenance period, regardless of the reason for the treatment discontinuation. | 0 | 52 | 5 | 52 | 49 | 52 |
| EG003 | Placebo - Actual Maintenance Treatment | This arm includes patients who were treated with placebo matching survodutide administered weekly at the start of the maintenance period, for patients who reached the maintenance period, regardless of whether this was the randomised (planned) dose or not, and regardless of whether the patient stayed on that dose throughout the maintenance period. This arm includes also those patients who were receiving Placebo matching survodutide administered weekly and who discontinued treatment prior to the maintenance period, regardless of the reason for the treatment discontinuation. | 0 | 79 | 5 | 79 | 68 | 79 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Blindness transient | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Intestinal polyp | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Puncture site pain | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Glomerular filtration rate decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abnormal uterine bleeding | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Combined pulmonary fibrosis and emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Early satiety | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 19, 2024 | Nov 6, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000726451 | BI 456906 |
Not provided
Not provided
Not provided
| Burden of study procedures |
|
| Change of residence |
|
| Perceived lack of efficacy |
|
| Adverse Event |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Stage 1B |
|
| Stage 1C |
|
| Stage 2 |
|
| Stage 3 |
|
| Yes |
|
| 1 |
|
| 2 |
|
| 3 |
|
| 4 |
|
| 5 |
|
| 6 |
|
| 7 |
|
| 8 |
|
| 1 |
|
| 2 |
|
| 3 |
|
| Lobular inflammation |
|
| 1 |
|
| 2 |
|
| Placebo - Actual Maintenance Treatment |
This arm includes patients who were treated with placebo matching survodutide administered weekly at the start of the maintenance period, for patients who reached the maintenance period, regardless of whether this was the randomised (planned) dose or not, and regardless of whether the patient stayed on that dose throughout the maintenance period. This arm includes also those patients who were receiving Placebo matching survodutide administered weekly and who discontinued treatment prior to the maintenance period, regardless of the reason for the treatment discontinuation. |
| The logistic regression model included actual treatment, presence of diabetes of any type and Baseline Fibrosis Score. Firth's penalized regression was used. | Regression, Logistic | <0.0001 | The p-value reported is considered nominal. | Odds Ratio (OR) | 9.52 | 2-Sided | 95 | 4.35 | 20.85 | Survodutide 4.8 mg vs. Placebo | Other | No confirmatory hypothesis testing was performed. |
| The logistic regression model included actual treatment, presence of diabetes of any type and Baseline Fibrosis Score. Firth's penalized regression was used. | Regression, Logistic | <.0001 | The p-value reported is considered nominal. | Odds Ratio (OR) | 7.07 | 2-Sided | 95 | 3.10 | 16.16 | Other | No confirmatory hypothesis testing was performed. |
| A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050). | MCP-Mod linear model fit | Linear model fit assumption | <0.0001 | Other | Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type [yes, no], baseline fibrosis score [F1, F2, F3] and the dose group as factors. P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed. |
| A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050). | MCP-Mod exponential-1 model fit | Model assumption: 25% of maximum effect is achieved at dose 3.0 mg. | <0.0001 | Other | Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type [yes, no], baseline fibrosis score [F1, F2, F3] and the dose group as factors. P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed. |
| A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050). | MCP-Mod exponential -2 model fit | Model assumption: 5% of maximum effect is achieved at dose 3.0 mg. | 0.0008 | Other | Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type [yes, no], baseline fibrosis score [F1, F2, F3] and the dose group as factors. P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed. |
| A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050). | MCP-Mod Emax1 model fit | Model assumption: 50% of maximum effect is achieved at dose 3.0 mg. | <0.0001 | Other | Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type [yes, no], baseline fibrosis score [F1, F2, F3] and the dose group as factors. P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed. |
| A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050). | MCP-Mod Emax2 model fit | Model assumption: 80% of maximum effect is achieved at dose 3.0 mg. | <0.0001 | Other | Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type [yes, no], baseline fibrosis score [F1, F2, F3] and the dose group as factors. P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed. |
| A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050). | MCP-Mod quadratic model fit | Model assumption: Maximum effect is achieved at dose 4.8 mg. | <0.0001 | Other | Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type [yes, no], baseline fibrosis score [F1, F2, F3] and the dose group as factors. P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed. |
Patients with non-alcoholic steatohepatitis (NASH) with non-alcoholic fatty liver disease (NAFLD) activity score (NAS) ≥4 and fibrosis stage 1-3 (F1-F3). were to be administered once weekly, subcutaneously a solution for injection of survodutide at a starting dose of 0.3 milligrams (mg) followed by a dose escalation up to the maintenance dose of 2.4 mg of survodutide.
The total treatment duration was 48 weeks (consisting of up to 24 weeks dose escalation period and at least 24 weeks maintenance period).
Participants not tolerating the assigned dose due to gastrointestinal adverse events had the option of a dose adjustment which could lead to a maintenance dose lower than the dose the patient was randomized to.
| OG001 | Survodutide 4.8 mg - Planned Maintenance Treatment | Patients with non-alcoholic steatohepatitis (NASH) with non-alcoholic fatty liver disease (NAFLD) activity score (NAS) ≥4 and fibrosis stage 1-3 (F1-F3). were to be administered once weekly, subcutaneously a solution for injection of survodutide at a starting dose of 0.3 milligrams (mg) followed by a dose escalation up to the maintenance dose of 4.8 mg of survodutide. The total treatment duration was 48 weeks (consisting of up to 24 weeks dose escalation period and at least 24 weeks maintenance period). Participants not tolerating the assigned dose due to gastrointestinal adverse events had the option of a dose adjustment which could lead to a maintenance dose lower than the dose the patient was randomized to. |
| OG002 | Survodutide 6.0 mg - Planned Maintenance Treatment | Patients with non-alcoholic steatohepatitis (NASH) with non-alcoholic fatty liver disease (NAFLD) activity score (NAS) ≥4 and fibrosis stage 1-3 (F1-F3). were to be administered once weekly, subcutaneously a solution for injection of survodutide at a starting dose of 0.3 milligrams (mg) followed by a dose escalation up to the maintenance dose of 6.0 mg of survodutide. The total treatment duration was 48 weeks (consisting of up to 24 weeks dose escalation period and at least 24 weeks maintenance period). Participants not tolerating the assigned dose due to gastrointestinal adverse events had the option of a dose adjustment which could lead to a maintenance dose lower than the dose the patient was randomized to. |
| OG003 | Placebo - Planned Maintenance Treatment | Patients with non-alcoholic steatohepatitis (NASH) with non-alcoholic fatty liver disease (NAFLD) activity score (NAS) ≥4 and fibrosis stage 1-3 (F1-F3). were administered once weekly, subcutaneously a solution for injection of placebo matching survodutide. The total treatment duration was 48 weeks (consisting of up to 24 weeks dose escalation period and at least 24 weeks maintenance period). |
|
|
|
| OG001 | Survodutide 4.8 mg - Actual Maintenance Treatment | This arm includes patients who were treated with 4.8 mg of survodutide administered weekly at the start of the maintenance period, for patients who reached the maintenance period, regardless of whether this was the randomised (planned) dose or not, and regardless of whether the patient stayed on that dose throughout the maintenance period. This arm includes also those patients for whom the next maintenance dose up from the dose at treatment discontinuation was 4.8 mg of survodutide administered weekly, for patients who discontinued treatment prior to the maintenance period, regardless of the reason for the treatment discontinuation. |
| OG002 | Survodutide 6.0 mg - Actual Maintenance Treatment | This arm includes patients who were treated with 6.0 mg of survodutide administered weekly at the start of the maintenance period, for patients who reached the maintenance period, regardless of whether this was the randomised (planned) dose or not, and regardless of whether the patient stayed on that dose throughout the maintenance period. This arm includes also those patients for whom the next maintenance dose up from the dose at treatment discontinuation was 6.0 mg of survodutide administered weekly, for patients who discontinued treatment prior to the maintenance period, regardless of the reason for the treatment discontinuation. |
| OG003 | Placebo - Actual Maintenance Treatment | This arm includes patients who were treated with placebo matching survodutide administered weekly at the start of the maintenance period, for patients who reached the maintenance period, regardless of whether this was the randomised (planned) dose or not, and regardless of whether the patient stayed on that dose throughout the maintenance period. This arm includes also those patients who were receiving Placebo matching survodutide administered weekly and who discontinued treatment prior to the maintenance period, regardless of the reason for the treatment discontinuation. |
|
|
|
| OG001 | Survodutide 4.8 mg - Planned Maintenance Treatment | Patients with non-alcoholic steatohepatitis (NASH) with non-alcoholic fatty liver disease (NAFLD) activity score (NAS) ≥4 and fibrosis stage 1-3 (F1-F3). were to be administered once weekly, subcutaneously a solution for injection of survodutide at a starting dose of 0.3 milligrams (mg) followed by a dose escalation up to the maintenance dose of 4.8 mg of survodutide. The total treatment duration was 48 weeks (consisting of up to 24 weeks dose escalation period and at least 24 weeks maintenance period). Participants not tolerating the assigned dose due to gastrointestinal adverse events had the option of a dose adjustment which could lead to a maintenance dose lower than the dose the patient was randomized to. |
| OG002 | Survodutide 6.0 mg - Planned Maintenance Treatment | Patients with non-alcoholic steatohepatitis (NASH) with non-alcoholic fatty liver disease (NAFLD) activity score (NAS) ≥4 and fibrosis stage 1-3 (F1-F3). were to be administered once weekly, subcutaneously a solution for injection of survodutide at a starting dose of 0.3 milligrams (mg) followed by a dose escalation up to the maintenance dose of 6.0 mg of survodutide. The total treatment duration was 48 weeks (consisting of up to 24 weeks dose escalation period and at least 24 weeks maintenance period). Participants not tolerating the assigned dose due to gastrointestinal adverse events had the option of a dose adjustment which could lead to a maintenance dose lower than the dose the patient was randomized to. |
| OG003 | Placebo - Planned Maintenance Treatment | Patients with non-alcoholic steatohepatitis (NASH) with non-alcoholic fatty liver disease (NAFLD) activity score (NAS) ≥4 and fibrosis stage 1-3 (F1-F3). were administered once weekly, subcutaneously a solution for injection of placebo matching survodutide. The total treatment duration was 48 weeks (consisting of up to 24 weeks dose escalation period and at least 24 weeks maintenance period). |
|
|
|
| OG001 | Survodutide 4.8 mg - Actual Maintenance Treatment | This arm includes patients who were treated with 4.8 mg of survodutide administered weekly at the start of the maintenance period, for patients who reached the maintenance period, regardless of whether this was the randomised (planned) dose or not, and regardless of whether the patient stayed on that dose throughout the maintenance period. This arm includes also those patients for whom the next maintenance dose up from the dose at treatment discontinuation was 4.8 mg of survodutide administered weekly, for patients who discontinued treatment prior to the maintenance period, regardless of the reason for the treatment discontinuation. |
| OG002 | Survodutide 6.0 mg - Actual Maintenance Treatment | This arm includes patients who were treated with 6.0 mg of survodutide administered weekly at the start of the maintenance period, for patients who reached the maintenance period, regardless of whether this was the randomised (planned) dose or not, and regardless of whether the patient stayed on that dose throughout the maintenance period. This arm includes also those patients for whom the next maintenance dose up from the dose at treatment discontinuation was 6.0 mg of survodutide administered weekly, for patients who discontinued treatment prior to the maintenance period, regardless of the reason for the treatment discontinuation. |
| OG003 | Placebo - Actual Maintenance Treatment | This arm includes patients who were treated with placebo matching survodutide administered weekly at the start of the maintenance period, for patients who reached the maintenance period, regardless of whether this was the randomised (planned) dose or not, and regardless of whether the patient stayed on that dose throughout the maintenance period. This arm includes also those patients who were receiving Placebo matching survodutide administered weekly and who discontinued treatment prior to the maintenance period, regardless of the reason for the treatment discontinuation. |
|
|
|
| OG001 | Survodutide 4.8 mg - Planned Maintenance Treatment | Patients with non-alcoholic steatohepatitis (NASH) with non-alcoholic fatty liver disease (NAFLD) activity score (NAS) ≥4 and fibrosis stage 1-3 (F1-F3). were to be administered once weekly, subcutaneously a solution for injection of survodutide at a starting dose of 0.3 milligrams (mg) followed by a dose escalation up to the maintenance dose of 4.8 mg of survodutide. The total treatment duration was 48 weeks (consisting of up to 24 weeks dose escalation period and at least 24 weeks maintenance period). Participants not tolerating the assigned dose due to gastrointestinal adverse events had the option of a dose adjustment which could lead to a maintenance dose lower than the dose the patient was randomized to. |
| OG002 | Survodutide 6.0 mg - Planned Maintenance Treatment | Patients with non-alcoholic steatohepatitis (NASH) with non-alcoholic fatty liver disease (NAFLD) activity score (NAS) ≥4 and fibrosis stage 1-3 (F1-F3). were to be administered once weekly, subcutaneously a solution for injection of survodutide at a starting dose of 0.3 milligrams (mg) followed by a dose escalation up to the maintenance dose of 6.0 mg of survodutide. The total treatment duration was 48 weeks (consisting of up to 24 weeks dose escalation period and at least 24 weeks maintenance period). Participants not tolerating the assigned dose due to gastrointestinal adverse events had the option of a dose adjustment which could lead to a maintenance dose lower than the dose the patient was randomized to. |
| OG003 | Placebo - Planned Maintenance Treatment | Patients with non-alcoholic steatohepatitis (NASH) with non-alcoholic fatty liver disease (NAFLD) activity score (NAS) ≥4 and fibrosis stage 1-3 (F1-F3). were administered once weekly, subcutaneously a solution for injection of placebo matching survodutide. The total treatment duration was 48 weeks (consisting of up to 24 weeks dose escalation period and at least 24 weeks maintenance period). |
|
|
|
| OG001 | Survodutide 4.8 mg - Actual Maintenance Treatment | This arm includes patients who were treated with 4.8 mg of survodutide administered weekly at the start of the maintenance period, for patients who reached the maintenance period, regardless of whether this was the randomised (planned) dose or not, and regardless of whether the patient stayed on that dose throughout the maintenance period. This arm includes also those patients for whom the next maintenance dose up from the dose at treatment discontinuation was 4.8 mg of survodutide administered weekly, for patients who discontinued treatment prior to the maintenance period, regardless of the reason for the treatment discontinuation. |
| OG002 | Survodutide 6.0 mg - Actual Maintenance Treatment | This arm includes patients who were treated with 6.0 mg of survodutide administered weekly at the start of the maintenance period, for patients who reached the maintenance period, regardless of whether this was the randomised (planned) dose or not, and regardless of whether the patient stayed on that dose throughout the maintenance period. This arm includes also those patients for whom the next maintenance dose up from the dose at treatment discontinuation was 6.0 mg of survodutide administered weekly, for patients who discontinued treatment prior to the maintenance period, regardless of the reason for the treatment discontinuation. |
| OG003 | Placebo - Actual Maintenance Treatment | This arm includes patients who were treated with placebo matching survodutide administered weekly at the start of the maintenance period, for patients who reached the maintenance period, regardless of whether this was the randomised (planned) dose or not, and regardless of whether the patient stayed on that dose throughout the maintenance period. This arm includes also those patients who were receiving Placebo matching survodutide administered weekly and who discontinued treatment prior to the maintenance period, regardless of the reason for the treatment discontinuation. |
|
|
|
| OG001 | Survodutide 4.8 mg - Planned Maintenance Treatment | Patients with non-alcoholic steatohepatitis (NASH) with non-alcoholic fatty liver disease (NAFLD) activity score (NAS) ≥4 and fibrosis stage 1-3 (F1-F3). were to be administered once weekly, subcutaneously a solution for injection of survodutide at a starting dose of 0.3 milligrams (mg) followed by a dose escalation up to the maintenance dose of 4.8 mg of survodutide. The total treatment duration was 48 weeks (consisting of up to 24 weeks dose escalation period and at least 24 weeks maintenance period). Participants not tolerating the assigned dose due to gastrointestinal adverse events had the option of a dose adjustment which could lead to a maintenance dose lower than the dose the patient was randomized to. |
| OG002 | Survodutide 6.0 mg - Planned Maintenance Treatment | Patients with non-alcoholic steatohepatitis (NASH) with non-alcoholic fatty liver disease (NAFLD) activity score (NAS) ≥4 and fibrosis stage 1-3 (F1-F3). were to be administered once weekly, subcutaneously a solution for injection of survodutide at a starting dose of 0.3 milligrams (mg) followed by a dose escalation up to the maintenance dose of 6.0 mg of survodutide. The total treatment duration was 48 weeks (consisting of up to 24 weeks dose escalation period and at least 24 weeks maintenance period). Participants not tolerating the assigned dose due to gastrointestinal adverse events had the option of a dose adjustment which could lead to a maintenance dose lower than the dose the patient was randomized to. |
| OG003 | Placebo - Planned Maintenance Treatment | Patients with non-alcoholic steatohepatitis (NASH) with non-alcoholic fatty liver disease (NAFLD) activity score (NAS) ≥4 and fibrosis stage 1-3 (F1-F3). were administered once weekly, subcutaneously a solution for injection of placebo matching survodutide. The total treatment duration was 48 weeks (consisting of up to 24 weeks dose escalation period and at least 24 weeks maintenance period). |
|
|
|
| OG001 | Survodutide 4.8 mg - Actual Maintenance Treatment | This arm includes patients who were treated with 4.8 mg of survodutide administered weekly at the start of the maintenance period, for patients who reached the maintenance period, regardless of whether this was the randomised (planned) dose or not, and regardless of whether the patient stayed on that dose throughout the maintenance period. This arm includes also those patients for whom the next maintenance dose up from the dose at treatment discontinuation was 4.8 mg of survodutide administered weekly, for patients who discontinued treatment prior to the maintenance period, regardless of the reason for the treatment discontinuation. |
| OG002 | Survodutide 6.0 mg - Actual Maintenance Treatment | This arm includes patients who were treated with 6.0 mg of survodutide administered weekly at the start of the maintenance period, for patients who reached the maintenance period, regardless of whether this was the randomised (planned) dose or not, and regardless of whether the patient stayed on that dose throughout the maintenance period. This arm includes also those patients for whom the next maintenance dose up from the dose at treatment discontinuation was 6.0 mg of survodutide administered weekly, for patients who discontinued treatment prior to the maintenance period, regardless of the reason for the treatment discontinuation. |
| OG003 | Placebo - Actual Maintenance Treatment | This arm includes patients who were treated with placebo matching survodutide administered weekly at the start of the maintenance period, for patients who reached the maintenance period, regardless of whether this was the randomised (planned) dose or not, and regardless of whether the patient stayed on that dose throughout the maintenance period. This arm includes also those patients who were receiving Placebo matching survodutide administered weekly and who discontinued treatment prior to the maintenance period, regardless of the reason for the treatment discontinuation. |
|
|
|
| OG001 | Survodutide 4.8 mg - Planned Maintenance Treatment | Patients with non-alcoholic steatohepatitis (NASH) with non-alcoholic fatty liver disease (NAFLD) activity score (NAS) ≥4 and fibrosis stage 1-3 (F1-F3). were to be administered once weekly, subcutaneously a solution for injection of survodutide at a starting dose of 0.3 milligrams (mg) followed by a dose escalation up to the maintenance dose of 4.8 mg of survodutide. The total treatment duration was 48 weeks (consisting of up to 24 weeks dose escalation period and at least 24 weeks maintenance period). Participants not tolerating the assigned dose due to gastrointestinal adverse events had the option of a dose adjustment which could lead to a maintenance dose lower than the dose the patient was randomized to. |
| OG002 | Survodutide 6.0 mg - Planned Maintenance Treatment | Patients with non-alcoholic steatohepatitis (NASH) with non-alcoholic fatty liver disease (NAFLD) activity score (NAS) ≥4 and fibrosis stage 1-3 (F1-F3). were to be administered once weekly, subcutaneously a solution for injection of survodutide at a starting dose of 0.3 milligrams (mg) followed by a dose escalation up to the maintenance dose of 6.0 mg of survodutide. The total treatment duration was 48 weeks (consisting of up to 24 weeks dose escalation period and at least 24 weeks maintenance period). Participants not tolerating the assigned dose due to gastrointestinal adverse events had the option of a dose adjustment which could lead to a maintenance dose lower than the dose the patient was randomized to. |
| OG003 | Placebo - Planned Maintenance Treatment | Patients with non-alcoholic steatohepatitis (NASH) with non-alcoholic fatty liver disease (NAFLD) activity score (NAS) ≥4 and fibrosis stage 1-3 (F1-F3). were administered once weekly, subcutaneously a solution for injection of placebo matching survodutide. The total treatment duration was 48 weeks (consisting of up to 24 weeks dose escalation period and at least 24 weeks maintenance period). |
|
|
|
| OG001 | Survodutide 4.8 mg - Actual Maintenance Treatment | This arm includes patients who were treated with 4.8 mg of survodutide administered weekly at the start of the maintenance period, for patients who reached the maintenance period, regardless of whether this was the randomised (planned) dose or not, and regardless of whether the patient stayed on that dose throughout the maintenance period. This arm includes also those patients for whom the next maintenance dose up from the dose at treatment discontinuation was 4.8 mg of survodutide administered weekly, for patients who discontinued treatment prior to the maintenance period, regardless of the reason for the treatment discontinuation. |
| OG002 | Survodutide 6.0 mg - Actual Maintenance Treatment | This arm includes patients who were treated with 6.0 mg of survodutide administered weekly at the start of the maintenance period, for patients who reached the maintenance period, regardless of whether this was the randomised (planned) dose or not, and regardless of whether the patient stayed on that dose throughout the maintenance period. This arm includes also those patients for whom the next maintenance dose up from the dose at treatment discontinuation was 6.0 mg of survodutide administered weekly, for patients who discontinued treatment prior to the maintenance period, regardless of the reason for the treatment discontinuation. |
| OG003 | Placebo - Actual Maintenance Treatment | This arm includes patients who were treated with placebo matching survodutide administered weekly at the start of the maintenance period, for patients who reached the maintenance period, regardless of whether this was the randomised (planned) dose or not, and regardless of whether the patient stayed on that dose throughout the maintenance period. This arm includes also those patients who were receiving Placebo matching survodutide administered weekly and who discontinued treatment prior to the maintenance period, regardless of the reason for the treatment discontinuation. |
|
|
| OG001 | Survodutide 4.8 mg - Planned Maintenance Treatment | Patients with non-alcoholic steatohepatitis (NASH) with non-alcoholic fatty liver disease (NAFLD) activity score (NAS) ≥4 and fibrosis stage 1-3 (F1-F3). were to be administered once weekly, subcutaneously a solution for injection of survodutide at a starting dose of 0.3 milligrams (mg) followed by a dose escalation up to the maintenance dose of 4.8 mg of survodutide. The total treatment duration was 48 weeks (consisting of up to 24 weeks dose escalation period and at least 24 weeks maintenance period). Participants not tolerating the assigned dose due to gastrointestinal adverse events had the option of a dose adjustment which could lead to a maintenance dose lower than the dose the patient was randomized to. |
| OG002 | Survodutide 6.0 mg - Planned Maintenance Treatment | Patients with non-alcoholic steatohepatitis (NASH) with non-alcoholic fatty liver disease (NAFLD) activity score (NAS) ≥4 and fibrosis stage 1-3 (F1-F3). were to be administered once weekly, subcutaneously a solution for injection of survodutide at a starting dose of 0.3 milligrams (mg) followed by a dose escalation up to the maintenance dose of 6.0 mg of survodutide. The total treatment duration was 48 weeks (consisting of up to 24 weeks dose escalation period and at least 24 weeks maintenance period). Participants not tolerating the assigned dose due to gastrointestinal adverse events had the option of a dose adjustment which could lead to a maintenance dose lower than the dose the patient was randomized to. |
| OG003 | Placebo - Planned Maintenance Treatment | Patients with non-alcoholic steatohepatitis (NASH) with non-alcoholic fatty liver disease (NAFLD) activity score (NAS) ≥4 and fibrosis stage 1-3 (F1-F3). were administered once weekly, subcutaneously a solution for injection of placebo matching survodutide. The total treatment duration was 48 weeks (consisting of up to 24 weeks dose escalation period and at least 24 weeks maintenance period). |
|
|