Long-Term Efficacy and Safety of Selective PPARδ Agonist Seladelpar in Primary Biliary Cholangitis: ASSURE Interim Study Results
Open accessAbstract
INTRODUCTION: The objective of these analyses was to evaluate interim data from the ongoing, open-label, long-term efficacy and safety ASSURE study of seladelpar, a selective peroxisome proliferator-activated receptor δ agonist, in primary biliary cholangitis. METHODS: Patients rolling over from the phase 3, randomized, placebo-controlled, 12-month RESPONSE study or with previous participation in earlier legacy seladelpar studies were enrolled. Interim evaluations included composite biochemical response (alkaline phosphatase <1.67 upper limit of normal, total bilirubin ≤ upper limit of normal, and alkaline phosphatase decrease ≥15%), pruritus numerical rating scale (NRS) change among patients with a baseline score ≥4, and safety. RESULTS: At interim cutoff, 337 patients were enrolled and received ≥1 seladelpar 10 mg dose: 54 placebo-treated and 104 seladelpar-treated from RESPONSE and 179 from legacy studies. The composite response rate at RESPONSE completion was 62% (79/128) with seladelpar and 20% (13/65) with placebo. After 12 months in ASSURE, among patients who rolled over from RESPONSE, response rates were 72% (21/29) in patients continuing seladelpar and 94% (15/16) in crossover seladelpar patients. In legacy trial patients, response rates were 73% (120/164) and 70% (69/99) after 12 and 24 months of treatment in ASSURE, respectively. The NRS decrease at RESPONSE completion in seladelpar-treated patients with baseline NRS ≥4 (−3.4) was maintained after 6 additional months of treatment (−3.8); changes were similar in crossover seladelpar (−3.8) and legacy patients (−3.5) after 6 months of treatment in ASSURE. No seladelpar-related serious adverse events were reported. DISCUSSION: Seladelpar demonstrated durable improvements in cholestatic biomarkers and pruritus in patients with primary biliary cholangitis with up to 2 years of treatment and remained overall safe with long-term use. Clinicaltrials.gov: NCT03301506.
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The side effects more commonly reported in the seladelpar study group were nausea, gastrointestinal discomfort, and mild headaches.
“The side effects that were more commonly reported in the study group were nausea, gastrointestinal discomfort, and mild headaches [16,23,47].”
From Second-Line Therapies in Primary Biliary Cholangitis: A Comparative Review of Obeticholic Acid, Fibrates, Seladelpar, and Elafibranor (2025) · cites this paper as [23]
The Results > Safety section lists nausea, diarrhea, and upper abdominal pain among the most common adverse events, supporting the nausea and gastrointestinal-symptom portions of the claim. It does not list headaches or establish that these events were more common in the seladelpar group than in a comparator group; it also does not describe headaches as mild. Page numbers were not provided in our copy. (LLM, conf=0.86)
Experimental — accuracy not yet measuredIn the ASSURE trial, among patients from the RESPONSE trial who continued seladelpar, at 12 months 38/53 patients (72%) sustained a composite biochemical response.
“Among patients from the RESPONSE trial who continued seladelpar, at 12 months 38/53 patients (72%) sustained a composite biochemical response.”
From Second-Line Therapies in Primary Biliary Cholangitis: A Comparative Review of Obeticholic Acid, Fibrates, Seladelpar, and Elafibranor (2025) · cites this paper as [23]
The Results > Efficacy passage reports a 72% composite biochemical response among RESPONSE patients who continued seladelpar and completed 12 additional months in ASSURE. It gives 21/29 patients, not the claimed 38/53. (LLM, conf=0.90)
Experimental — accuracy not yet measuredIn the ASSURE trial, in patients who had previously received seladelpar (n = 27), the mean decrease in pruritus NRS at month 18 was −3.5 to −3.8 points.
“Regarding symptoms, in patients who had previously received seladelpar (n = 27), the mean decrease in pruritus NRS at month 18 was −3.5 to −3.8 points.”
From Second-Line Therapies in Primary Biliary Cholangitis: A Comparative Review of Obeticholic Acid, Fibrates, Seladelpar, and Elafibranor (2025) · cites this paper as [23]
The Results (Efficacy, Pruritus; page unavailable) report a −3.8-point mean NRS change after 18 months of treatment for 26 patients who continued seladelpar, not 27. The −3.5-point change is reported for a different, legacy group after six months of treatment in ASSURE, so it is not a range for the previously treated group at month 18. (LLM, conf=0.90)
Experimental — accuracy not yet measuredIn the ASSURE trial, for ALP normalization, in the seladelpar continuation group, 9/53 (17%) achieved normalization at month 12 and in the crossover cohort, 27/54 (50%) achieved normalization at month 12.
“For ALP normalization, in the seladelpar continuation group, 9/53 (17%) achieved normalization at month 12 and in the crossover cohort, 27/54 (50%) achieved normalization at month 12.”
From Second-Line Therapies in Primary Biliary Cholangitis: A Comparative Review of Obeticholic Acid, Fibrates, Seladelpar, and Elafibranor (2025) · cites this paper as [23]
The Results > Efficacy passage reports the claimed month-12 ALP normalization rates of 17% for the continuous seladelpar group and 50% for the crossover group. The counts do not match: the paper reports 5/29 and 8/16, not 9/53 and 27/54. (LLM, conf=0.90)
Experimental — accuracy not yet measuredIn the ASSURE trial, at 24 months, across the broader population that included both RESPONSE trial and legacy phase 2 patients (n ≈ 145), composite biochemical response rates were sustained in 70-73%, while ALP normalization increased further to 42% (n ≈ 61/145).
“At 24 months, across the broader population that included both RESPONSE trial and legacy phase 2 patients (n ≈ 145), composite biochemical response rates were sustained in 70–73%, while ALP normalization increased further to 42% (n ≈ 61/145).”
From Second-Line Therapies in Primary Biliary Cholangitis: A Comparative Review of Obeticholic Acid, Fibrates, Seladelpar, and Elafibranor (2025) · cites this paper as [23]
Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measured
In the ASSURE trial, the group that had originally received placebo in RESPONSE trial but was then started on seladelpar de novo, 51/54 patients (94%) newly achieved the composite endpoint at 12 months.
“As for the group that had originally received placebo in RESPONSE trial but was then started on seladelpar de novo in ASSURE trial, 51/54 patients (94%) newly achieved the composite endpoint at 12 months.”
From Second-Line Therapies in Primary Biliary Cholangitis: A Comparative Review of Obeticholic Acid, Fibrates, Seladelpar, and Elafibranor (2025) · cites this paper as [23]
The Results > Efficacy section (page not provided) reports a 94% composite biochemical response in the placebo-to-seladelpar crossover group after 12 months in ASSURE, but that is 15 of 16 patients who completed 12 months, not 51 of 54. The 54 is the number of crossover patients who received seladelpar at the interim cutoff, not the denominator for the 12-month response rate. (LLM, conf=0.93)
Experimental — accuracy not yet measuredAdverse events with seladelpar were almost identical to placebo when observed in both short and long-term studies.
“Adverse events were almost identical to placebo when observed in both short and long-term studies [16,23,47].”
From Second-Line Therapies in Primary Biliary Cholangitis: A Comparative Review of Obeticholic Acid, Fibrates, Seladelpar, and Elafibranor (2025) · cites this paper as [23]
Pruritus was less frequent in seladelpar when compared to placebo.
“As detailed earlier, pruritus was less frequent in seladelpar when compared to placebo.”
From Second-Line Therapies in Primary Biliary Cholangitis: A Comparative Review of Obeticholic Acid, Fibrates, Seladelpar, and Elafibranor (2025) · cites this paper as [23]
Overall, seladelpar was well tolerated.
“Overall, seladelpar was well tolerated.”
From Second-Line Therapies in Primary Biliary Cholangitis: A Comparative Review of Obeticholic Acid, Fibrates, Seladelpar, and Elafibranor (2025) · cites this paper as [23]
In the ASSURE trial, ALT, AST, and GGT levels remained stable or continued to decline throughout the 24 months.
“As for liver injury markers, ALT, AST, and GGT levels remained stable or continued to decline throughout the 24 months.”
From Second-Line Therapies in Primary Biliary Cholangitis: A Comparative Review of Obeticholic Acid, Fibrates, Seladelpar, and Elafibranor (2025) · cites this paper as [23]
There were no reported treatment-related deaths with seladelpar.
“There were no reported treatment-related deaths [16,23,47].”
From Second-Line Therapies in Primary Biliary Cholangitis: A Comparative Review of Obeticholic Acid, Fibrates, Seladelpar, and Elafibranor (2025) · cites this paper as [23]
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- Authors
- Levy, C., Trivedi, P. J., Kowdley, K. V., Gordon, S. C., Bowlus, C. L., Londoño, M. C., Hirschfield, G. M., Gulamhusein, A., Lawitz, E. J., Vierling, J. M., Mayo, M. J., Jacobson, I. M., Kremer, A. E., Corpechot, C., Jones, D., Buggisch, P., Zhuo, S., Proehl, S., Heusner, C., McWherter, C. A., Crittenden, D. B., & on behalf of the ASSURE Investigators
- Affiliations
- University of Miami (US)
- University Hospitals Birmingham NHS Foundation Trust (GB)
- Liver Institute Northwest (US)
- Henry Ford Hospital (US)
- University of California Davis Medical Center (US)
- Liver Unit, Hospital Clínic de Barcelona, Fundació de Recerca Clínic Barcelona-Institut d’Investigacions Biomèdiques August Pi i Sunyer, CIBEREHD, European Reference Network on Hepatological Diseases (ERN-LIVER), University of Barcelona, Barcelona, Spain;
- Toronto General Hospital (CA)
- The University of Texas at San Antonio Health Science Center (US)
- Baylor College of Medicine (US)
- The University of Texas Southwestern Medical Center (US)
- NYU Langone Health (US)
- University of Zurich (CH)
- Sorbonne Université (FR)
- Newcastle upon Tyne Hospitals NHS Foundation Trust (GB)
- Liver Centre Hamburg at Ifi-Institute, Hamburg, Germany;
- CymaBay Therapeutics (United States) (US)
- Gilead Sciences (United States) (US)
- Corresponding author
- McWherter, Charles A.
- Crittenden, Daria B.
- ORCID
- Levy, Cynthia
- Trivedi, Palak J.
- Kowdley, Kris V.
- Gordon, Stuart C.
- Bowlus, Christopher L.
- Londoño, Maria Carlota
- Hirschfield, Gideon M.
- Gulamhusein, Aliya
- Lawitz, Eric J.
- Vierling, John M.
- Mayo, Marlyn J.
- Jacobson, Ira M.
- Kremer, Andreas E.
- Corpechot, Christophe
- Jones, David
- Buggisch, Peter
- Proehl, Sarah
- McWherter, Charles A.
- Crittenden, Daria B.
- Venue
- American Journal of Gastroenterology
- Published
- 2025-06-24
- Volume
- 121
- Issue
- 5
- Pages
- 1140-1153
- ISSN
- 0002-9270 (ISSN-L)
- 1572-0241
- PMC
- PMC13127731
- OpenAlex
- W4411582238
- Cited by
- 20
- References
- 28
- Citations by year
- 2026: 17 · 2025: 3
- FWCI
- 11.24
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- The American Journal of Gastroenterology (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- Zurich Open Repository and Archive (University of Zurich) (submittedVersion, cc-by-nc-nd)
- Zurich Open Repository and Archive (University of Zurich)
- Funders
- Gilead Sciences
- Topics
- Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Peroxisome Proliferator-Activated Receptors
- Health Sciences › Medicine › Oncology › Drug Transport and Resistance Mechanisms
- Keywords
- seladelpar, primary biliary cirrhosis, PPARδ agonist, ASSURE trial, long-term efficacy, pruritus, alkaline phosphatase, total bilirubin, drug safety, open-label extension, durable response, bile duct diseases, cholestatic liver disease, drug repurposing
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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