A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Compensated Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ENLIGHTEN-Cirrhosis)
1 other identifier
interventional
762
23 countries
296
Brief Summary
The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH \[previously known as nonalcoholic steatohepatitis, NASH\]).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2024
Longer than P75 for phase_3
296 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2024
CompletedFirst Posted
Study publicly available on registry
May 17, 2024
CompletedStudy Start
First participant enrolled
May 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2031
May 6, 2026
May 1, 2026
4 years
May 14, 2024
May 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Proportion of Participants Achieving Fibrosis Regression
Fibrosis regression is defined as improvement in fibrosis by ≥1 stage, at Month 24 biopsy relative to baseline biopsy.
Baseline through Month 24
Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events
Baseline up to 5 years
Secondary Outcomes (4)
Change from Baseline in Enhanced Liver Fibrosis (ELF) Score
Baseline, up to Month 60
Change from Baseline in Alanine Aminotransferase (ALT) Level
Baseline, up to Month 60
Change from Baseline in FibroScan Vibration-controlled Transient Elastography (VCTE)
Baseline, up to Month 60
Proportion of Participants who Develop Clinically Significant Portal Hypertension (CSPH)
Baseline up to Month 60
Study Arms (2)
Pegozafermin
EXPERIMENTALPlacebo
PLACEBO COMPARATORMatched placebo
Interventions
Eligibility Criteria
You may qualify if:
- Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF).
- Participants must have type 2 diabetes mellitus diagnosed at least 3 months before screening or at least 2 metabolic risk factors.
- Biopsy-confirmed fibrosis stage F4 MASH (NASH Clinical Research Network (CRN) system) with compensated cirrhosis.
- Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and \<50.0 kilograms (kg)/meters squared (m\^2).
You may not qualify if:
- Liver disorder other than MASH.
- History or evidence of hepatic decompensation.
- History or evidence of hepatocellular carcinoma.
- Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.
- ALT or aspartate aminotransferase (AST) ≥250 units per liter (U/L).
- Participants taking vitamin E (\>400 international units \[IU\]/day) must be on stable dose for at least 6 months prior to screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- 89bio, Inc.lead
Study Sites (296)
89bio Clinical Study Site
Birmingham, Alabama, 35205, United States
89bio Clinical Study Site
Homewood, Alabama, 35209, United States
89bio Clinical Study Site
Chandler, Arizona, 85224, United States
89bio Clinical Study Site
Flagstaff, Arizona, 86001, United States
89bio Clinical Study Site
Peoria, Arizona, 85381, United States
89bio Clinical Study Site
Phoenix, Arizona, 85054, United States
89bio Clinical Study Site
Tucson, Arizona, 85712, United States
89bio Clinical Study Site
Tucson, Arizona, 85715, United States
89bio Clinical Study Site
Tucson, Arizona, 85716, United States
89bio Clinical Study Site
Little Rock, Arkansas, 72205, United States
89bio Clinical Study Site
North Little Rock, Arkansas, 72117, United States
89bio Clinical Study Site
Camarillo, California, 93012, United States
89bio Clinical Study Site
Canoga Park, California, 91304, United States
89bio Clinical Study Site
Coronado, California, 92118, United States
89bio Clinical Study Site
Fountain Valley, California, 92708, United States
89bio Clinical Study Site
Fresno, California, 93720, United States
89bio Clinical Study Site
Huntington Park, California, 90255, United States
89bio Clinical Study Site
La Jolla, California, 92037-0887, United States
89bio Clinical Study Site
Los Angeles, California, 90033, United States
89bio Clinical Study Site
Los Angeles, California, 90048, United States
89bio Clinical Study Site
Pasadena, California, 91105, United States
89bio Clinical Study Site
Poway, California, 92064, United States
89bio Clinical Study Site
Redwood City, California, 94063, United States
89bio Clinical Study Site
Rialto, California, 92377, United States
89bio Clinical Study Site
Sacramento, California, 95817, United States
89bio Clinical Study Site
Santa Ana, California, 92704, United States
89bio Clinical Study Site
Littleton, Colorado, 80120, United States
89bio Clinical Study Site
Clermont, Florida, 34711, United States
89bio Clinical Study Site
Fort Myers, Florida, 33912, United States
89bio Clinical Study Site
Gainesville, Florida, 32610, United States
89bio Clinical Study Site
Hialeah Gardens, Florida, 33016, United States
89bio Clinical Study Site
Homestead, Florida, 33030, United States
89bio Clinical Study Site
Jacksonville, Florida, 32224, United States
89bio Clinical Study Site
Jacksonville, Florida, 32256, United States
89bio Clinical Study Site
Lady Lake, Florida, 32159, United States
89bio Clinical Study Site
Lakewood Rch, Florida, 34211, United States
89bio Clinical Study Site
Lehigh Acres, Florida, 33936, United States
89bio Clinical Study Site
Maitland, Florida, 32751, United States
89bio Clinical Study Site
Miami, Florida, 33144, United States
89bio Clinical Study Site
Miami, Florida, 33176-1530, United States
89bio Clinical Study Site
Miami, Florida, 33176-7947, United States
89bio Clinical Study Site
New Port Richey, Florida, 34653, United States
89bio Clinical Study Site
Ocala, Florida, 34471, United States
89bio Clinical Study Site
Ocoee, Florida, 34761, United States
89bio Clinical Study Site
Orlando, Florida, 32825, United States
89bio Clinical Study Site
University Park, Florida, 34201, United States
89bio Clinical Study Site
Viera, Florida, 32940, United States
89bio Clinical Study Site
Winter Park, Florida, 32789, United States
89bio Clinical Study Site
Athens, Georgia, 30607, United States
89bio Clinical Study Site
Atlanta, Georgia, 30309, United States
89bio Clinical Study Site
Chicago, Illinois, 60611, United States
89bio Clinical Study Site
Hammond, Indiana, 46324, United States
89bio Clinical Study Site
New Albany, Indiana, 47150, United States
89bio Clinical Study Site
South Bend, Indiana, 46635, United States
89bio Clinical Study Site
Iowa City, Iowa, 52242, United States
89bio Clinical Study Site
Kansas City, Kansas, 66160, United States
89bio Clinical Study Site
Topeka, Kansas, 66606, United States
89bio Clinical Study Site
Lafayette, Louisiana, 70503, United States
89bio Clinical Study Site
Lake Charles, Louisiana, 70605, United States
89bio Clinical Study Site
West Monroe, Louisiana, 71291, United States
89bio Clinical Study Site
Baltimore, Maryland, 21202, United States
89bio Clinical Study Site
Glen Burnie, Maryland, 21061, United States
89bio Clinical Study Site
Greenbelt, Maryland, 20770, United States
89bio Clinical Study Site
Burlington, Massachusetts, 01805, United States
89bio Clinical Study Site
Ann Arbor, Michigan, 48109, United States
89bio Clinical Study Site
Clinton Township, Michigan, 48038, United States
89bio Clinical Study Site
Detroit, Michigan, 48202, United States
89bio Clinical Study Site
Wyoming, Michigan, 49519, United States
89bio Clinical Study Site
Ypsilanti, Michigan, 48197, United States
89bio Clinical Study Site
Minneapolis, Minnesota, 55413, United States
89bio Clinical Study Site
Rochester, Minnesota, 55905, United States
89bio Clinical Study Site
Flowood, Mississippi, 39232, United States
89bio Clinical Study Site
Tupelo, Mississippi, 38801, United States
89bio Clinical Study Site
St Louis, Missouri, 63110, United States
89bio Clinical Study Site
St Louis, Missouri, 63123, United States
89bio Clinical Study Site
Las Vegas, Nevada, 89106, United States
89bio Clinical Study Site
Florham Park, New Jersey, 07932, United States
89bio Clinical Study Site
Somers Point, New Jersey, 08244, United States
89bio Clinical Study Site
Albuquerque, New Mexico, 87109, United States
89bio Clinical Study Site
New York, New York, 10016, United States
89bio Clinical Study Site
New York, New York, 10021, United States
89bio Clinical Study Site
New York, New York, 10033, United States
89bio Clinical Study Site
Asheville, North Carolina, 28801, United States
89bio Clinical Study Site
Charlotte, North Carolina, 28207, United States
89bio Clinical Study Site
Durham, North Carolina, 27710, United States
89bio Clinical Study Site
Fayetteville, North Carolina, 28304, United States
89bio Clinical Study Site
Greenville, North Carolina, 27834, United States
89bio Clinical Study Site
Winston-Salem, North Carolina, 27103, United States
89bio Clinical Study Site
Akron, Ohio, 44320, United States
89bio Clinical Study Site
Cincinnati, Ohio, 45267, United States
89bio Clinical Study Site
Cleveland, Ohio, 44106, United States
89bio Clinical Study Site
Columbus, Ohio, 43210, United States
89bio Clinical Study Site
Dayton, Ohio, 45414, United States
89bio Clinical Study Site
Liberty Township, Ohio, 45044, United States
89bio Clinical Study Site
Westlake, Ohio, 44145, United States
89bio Clinical Study Site
Philadelphia, Pennsylvania, 19148, United States
89bio Clinical Study Site
Pittsburgh, Pennsylvania, 15213, United States
89bio Clinical Study Site
East Greenwich, Rhode Island, 02818, United States
89bio Clinical Study Site
Charleston, South Carolina, 29425, United States
89bio Clinical Study Site
Columbia, South Carolina, 29204, United States
89bio Clinical Study Site
Rapid City, South Dakota, 57701, United States
89bio Clinical Study Site
Cordova, Tennessee, 38018, United States
89bio Clinical Study Site
Hermitage, Tennessee, 37076, United States
89bio Clinical Study Site
Nashville, Tennessee, 37211, United States
89bio Clinical Study Site
Amarillo, Texas, 79106, United States
89bio Clinical Study Site
Austin, Texas, 78745, United States
89bio Clinical Study Site
Austin, Texas, 78757-8059, United States
89bio Clinical Study Site
Austin, Texas, 78757-8066, United States
89bio Clinical Study Site
Brownsville, Texas, 78520, United States
89bio Clinical Study Site
DeSoto, Texas, 75115, United States
89bio Clinical Study Site
Edinburg, Texas, 78539, United States
89bio Clinical Study Site
Farmers Branch, Texas, 75234, United States
89bio Clinical Study Site
Fort Worth, Texas, 76104, United States
89bio Clinical Study Site
Harlingen, Texas, 78550, United States
89bio Clinical Study Site
Houston, Texas, 77030, United States
89bio Clinical Study Site
Houston, Texas, 77074, United States
89bio Clinical Study Site
Houston, Texas, 77099, United States
89bio Clinical Study Site
Lewisville, Texas, 75067, United States
89bio Clinical Study Site
Lubbock, Texas, 79410, United States
89bio Clinical Study Site
Mansfield, Texas, 76063, United States
89bio Clinical Study Site
Pearland, Texas, 77584, United States
89bio Clinical Study Site
San Antonio, Texas, 78209, United States
89bio Clinical Study Site
San Antonio, Texas, 78229-4801, United States
89bio Clinical Study Site
San Antonio, Texas, 78229-5069, United States
89bio Clinical Study Site
San Marcos, Texas, 78666, United States
89bio Clinical Study Site
Waco, Texas, 76710, United States
89bio Clinical Study Site
Waco, Texas, 76712, United States
89bio Clinical Study Site
Sandy City, Utah, 84092, United States
89bio Clinical Study Site
West Jordan, Utah, 84088, United States
89bio Clinical Study Site
Richmond, Virginia, 23226, United States
89bio Clinical Study Site
Richmond, Virginia, 23229, United States
89bio Clinical Study Site
Richmond, Virginia, 23236, United States
89bio Clinical Study Site
Richmond, Virginia, 23298, United States
89bio Clinical Study Site
Seattle, Washington, 98101, United States
89bio Clinical Study Site
Seattle, Washington, 98105, United States
89bio Clinical Study Site
Buenos Aires, C1012AAR, Argentina
89bio Clinical Study Site
Buenos Aires, C1125ABE, Argentina
89bio Clinical Study Site
Buenos Aires, C1199ABB, Argentina
89bio Clinical Study Site
Buenos Aires, C1425BGH, Argentina
89bio Clinical Study Site
Buenos Aires, CP 1061, Argentina
89bio Clinical Study Site
CABA, C1430CKE, Argentina
89bio Clinical Study Site
Capital Federal, C1280AEB, Argentina
89bio Clinical Study Site
Pilar, B1629AHJ, Argentina
89bio Clinical Study Site
Adelaide, SA 5000, Australia
89bio Clinical Study Site
Fitzroy, 03065, Australia
89bio Clinical Study Site
Greenslopes, 04120, Australia
89bio Clinical Study Site
Heidelberg, 3084, Australia
89bio Clinical Study Site
Herston, Qld 4029, Australia
89bio Clinical Study Site
Murdoch, 06150, Australia
89bio Clinical Study Site
Perth, 06000, Australia
89bio Clinical Study Site
South Brisbane, 04101, Australia
89bio Clinical Study Site
Brussels, 01070, Belgium
89bio Clinical Study Site
Brussels, 01090, Belgium
89bio Clinical Study Site
Brussels, 1200, Belgium
89bio Clinical Study Site
Edegem, 02650, Belgium
89bio Clinical Study Site
Genk, 03600, Belgium
89bio Clinical Study Site
Ghent, 09000, Belgium
89bio Clinical Study Site
Roeselare, 08800, Belgium
89bio Clinical Study Site
Barretos, 14784-400, Brazil
89bio Clinical Study Site
Belo Horizonte, 30220-140, Brazil
89bio Clinical Study Site
Botucatu, 18618-687, Brazil
89bio Clinical Study Site
Goiânia, 74605-050, Brazil
89bio Clinical Study Site
Porto Alegre, 90035-903, Brazil
89bio Clinical Study Site
Rio de Janeiro, 21941-617, Brazil
89bio Clinical Study Site
Salvador, 41820-460, Brazil
89bio Clinical Study Site
São José do Rio Preto, 15090-000, Brazil
89bio Clinical Study Site
São Paulo, 04038-002, Brazil
89bio Clinical Study Site
Gorna Oryahovitsa, 05100, Bulgaria
89bio Clinical Study Site
Sofia, 01202, Bulgaria
89bio Clinical Study Site
Sofia, 01407, Bulgaria
89bio Clinical Study Site
Stara Zagora, 06003, Bulgaria
89bio Clinical Study Site
Calgary, Alberta, T2N 4Z6, Canada
89bio Clinical Study Site
Vancouver, British Columbia, V5Z 1M9, Canada
89bio Clinical Study Site
Vancouver, British Columbia, V6Z2K5, Canada
89bio Clinical Study Site
Winnipeg, Manitoba, R3E 3P4, Canada
89bio Clinical Study Site
London, Ontario, N6A5A5, Canada
89bio Clinical Study Site
Ottawa, Ontario, K1H 8L6, Canada
89bio Clinical Study Site
Toronto, Ontario, M6H3M1, Canada
89bio Clinical Study Site
Vaughan, L4L 4Y7, Canada
89bio Clinical Study Site
Amiens, 80054, France
89bio Clinical Study Site
Dijon, 21000, France
89bio Clinical Study Site
Limoges, 87000, France
89bio Clinical Study Site
Lyon, 69004, France
89bio Clinical Study Site
Montpellier, 34295, France
89bio Clinical Study Site
Nice, 06202, France
89bio Clinical Study Site
Paris, 75012, France
89bio Clinical Study Site
Paris, 75013, France
89bio Clinical Study Site
Paris, 75014, France
89bio Clinical Study Site
Pessac, 33604, France
89bio Clinical Study Site
Strasbourg, 67091, France
89bio Clinical Study Site
Toulouse, 31400, France
89bio Clinical Study Site
Vandœuvre-lès-Nancy, 54500, France
89bio Clinical Study Site
Vénissieux, 69694, France
89bio Clinical Study Site
Villejuif, 94800, France
89bio Clinical Study Site
Chemnitz, 9116, Germany
89bio Clinical Study Site
Frankfurt, 60590, Germany
89bio Clinical Study Site
Freiburg im Breisgau, 79110, Germany
89bio Clinical Study Site
Hanover, 30625, Germany
89bio Clinical Study Site
Homburg, 66421, Germany
89bio Clinical Study Site
Münster, 48149, Germany
89bio Clinical Study Site
Hong Kong, Hong Kong
89bio Clinical Study Site
Shatin, Hong Kong
89bio Clinical Study Site
Budapest, 01027, Hungary
89bio Clinical Study Site
Budapest, 01088, Hungary
89bio Clinical Study Site
Budapest, H-1097, Hungary
89bio Clinical Study Site
Afula, 1834111, Israel
89bio Clinical Study Site
Beersheba, 8410101, Israel
89bio Clinical Study Site
Haifa, 3109601, Israel
89bio Clinical Study Site
Haifa, 3436212, Israel
89bio Clinical Study Site
Jerusalem, 9112001, Israel
89bio Clinical Study Site
Nahariya, 2210001, Israel
89bio Clinical Study Site
Petah Tikva, 49100, Israel
89bio Clinical Study Site
Tel Aviv, 69710, Israel
89bio Clinical Study Site
Tel Litwinsky, 5265601, Israel
89bio Clinical Study Site
Bergamo, 24127, Italy
89bio Clinical Study Site
Foggia, 71121, Italy
89bio Clinical Study Site
Milan, 20122, Italy
89bio Clinical Study Site
Milan, 20162, Italy
89bio Clinical Study Site
Novara, 28100, Italy
89bio Clinical Study Site
Palermo, 90127, Italy
89bio Clinical Study Site
Roma, 00128, Italy
89bio Clinical Study Site
Rome, 00168, Italy
89bio Clinical Study Site
Rozzano, 20089, Italy
89bio Clinical Study Site
Torino, 10124, Italy
89bio Clinical Study Site
Chihuahua City, 31217, Mexico
89bio Clinical Study Site
Cuautitlán Izcalli, CP 54769, Mexico
89bio Clinical Study Site
Cuernavaca, 62250, Mexico
89bio Clinical Study Site
Jalisco, 44130, Mexico
89bio Clinical Study Site
Mexico City, 03330, Mexico
89bio Clinical Study Site
Mexico City, 06700, Mexico
89bio Clinical Study Site
Mérida, 97070, Mexico
89bio Clinical Study Site
Monterrey, 64310, Mexico
89bio Clinical Study Site
Amsterdam, 1081 HV, Netherlands
89bio Clinical Study Site
Rotterdam, 3015GD, Netherlands
89bio Clinical Study Site
Tilburg, 5022 GC, Netherlands
89bio Clinical Study Site
Utrecht, 3584 CX, Netherlands
89bio Clinical Study Site
Katowice, 40-752, Poland
89bio Clinical Study Site
Krakow, 31-501, Poland
89bio Clinical Study Site
Lodz, 90-302, Poland
89bio Clinical Study Site
Lodz, 91-363, Poland
89bio Clinical Study Site
Mysłowice, 41-400, Poland
89bio Clinical Study Site
Warsaw, 00-215, Poland
89bio Clinical Study Site
Warsaw, 04-501, Poland
89bio Clinical Study Site
Wroclaw, 53-673, Poland
89bio Clinical Study Site
Mayagüez, 00680, Puerto Rico
89bio Clinical Study Site
San Juan, 00927, Puerto Rico
89bio Clinical Study Site
Singapore, 119074, Singapore
89bio Clinical Study Site
Singapore, 169608, Singapore
89bio Clinical Study Site
Singapore, 308433, Singapore
89bio Clinical Study Site
Singapore, 529889, Singapore
89bio Clinical Study Site
Bucheon-si, 14584, South Korea
89bio Clinical Study Site
Busan, 49241, South Korea
89bio Clinical Study Site
Daegu, 42415, South Korea
89bio Clinical Study Site
Daegu, 700-712, South Korea
89bio Clinical Study Site
Seoul, 03080, South Korea
89bio Clinical Study Site
Seoul, 06591, South Korea
89bio Clinical Study Site
Seoul, 07061, South Korea
89bio Clinical Study Site
Seoul, 07895, South Korea
89bio Clinical Study Site
Seoul, 130-872, South Korea
89bio Clinical Study Site
Almería, 04009, Spain
89bio Clinical Study Site
Badalona, 08916, Spain
89bio Clinical Study Site
Barcelona, 08003, Spain
89bio Clinical Study Site
Barcelona, 08035, Spain
89bio Clinical Study Site
Barcelona, 08041, Spain
89bio Clinical Study Site
Córdoba, 14004, Spain
89bio Clinical Study Site
Madrid, 28007, Spain
89bio Clinical Study Site
Málaga, 29010, Spain
89bio Clinical Study Site
Pontevedra, 36071, Spain
89bio Clinical Study Site
Santander, 39008, Spain
89bio Clinical Study Site
Santiago de Compostela, 15706, Spain
89bio Clinical Study Site
Zaragoza, 50009, Spain
89bio Clinical Study Site
Chiayi City, 60002, Taiwan
89bio Clinical Study Site
Kaohsiung City, 80756, Taiwan
89bio Clinical Study Site
Tainan, 00704, Taiwan
89bio Clinical Study Site
Bornova, İzmir, 35040, Turkey (Türkiye)
89bio Clinical Study Site
Merkez, Rize Province, 53020, Turkey (Türkiye)
89bio Clinical Study Site
Ankara, 06100, Turkey (Türkiye)
89bio Clinical Study Site
Ankara, 6800, Turkey (Türkiye)
89bio Clinical Study Site
Fatih, 34093, Turkey (Türkiye)
89bio Clinical Study Site
Istanbul, 34010, Turkey (Türkiye)
89bio Clinical Study Site
Istanbul, 34722, Turkey (Türkiye)
89bio Clinical Study Site
Izmir, 35360, Turkey (Türkiye)
89bio Clinical Study Site
Umraniye, 34764, Turkey (Türkiye)
89bio Clinical Study Site
Yüreğir, 1370, Turkey (Türkiye)
89bio Clinical Study Site
Aberdeen, AB25 2ZN, United Kingdom
89bio Clinical Study Site
Bristol, BS10 5NB, United Kingdom
89bio Clinical Study Site
Leeds, LS9 7TF, United Kingdom
89bio Clinical Study Site
London, E1 1BB, United Kingdom
89bio Clinical Study Site
London, NW3 2QG, United Kingdom
89bio Clinical Study Site
London, SE5 9RS, United Kingdom
89bio Clinical Study Site
London, W2 1NY, United Kingdom
89bio Clinical Study Site
Oxford, OX3 9DU, United Kingdom
89bio Clinical Study Site
Plymouth, PL6 8DH, United Kingdom
89bio Clinical Study Site
Port Talbot, SA12 7BR, United Kingdom
89bio Clinical Study Site
Portsmouth, P06 3LY, United Kingdom
89bio Clinical Study Site
Southampton, SO16 6YD, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Maya Margalit, MD
89bio, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2024
First Posted
May 17, 2024
Study Start
May 24, 2024
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
August 1, 2031
Last Updated
May 6, 2026
Record last verified: 2026-05