Seladelpar efficacy and safety at 3 months in patients with primary biliary cholangitis: ENHANCE, a phase 3, randomized, placebo-controlled study
Open accessAbstract
Background and Aims: ENHANCE was a phase 3 study that evaluated efficacy and safety of seladelpar, a selective peroxisome proliferator-activated receptor-δ (PPAR) agonist, versus placebo in patients with primary biliary cholangitis with inadequate response or intolerance to ursodeoxycholic acid (UDCA). Approach and Results: Patients were randomized 1:1:1 to oral seladelpar 5 mg (n=89), 10 mg (n=89), placebo (n=87) daily (with UDCA, as appropriate). Primary end point was a composite biochemical response [alkaline phosphatase (ALP) < 1.67×upper limit of normal (ULN), ≥15% ALP decrease from baseline, and total bilirubin ≤ ULN] at month 12. Key secondary end points were ALP normalization at month 12 and change in pruritus numerical rating scale (NRS) at month 6 in patients with baseline score ≥4. Aminotransferases were assessed. ENHANCE was terminated early following an erroneous safety signal in a concurrent, NASH trial. While blinded, primary and secondary efficacy end points were amended to month 3. Significantly more patients receiving seladelpar met the primary end point (seladelpar 5 mg: 57.1%, 10 mg: 78.2%) versus placebo (12.5%) (p < 0.0001). ALP normalization occurred in 5.4% (p=0.08) and 27.3% (p < 0.0001) of patients receiving 5 and 10 mg seladelpar, respectively, versus 0% receiving placebo. Seladelpar 10 mg significantly reduced mean pruritus NRS versus placebo [10 mg: −3.14 (p=0.02); placebo: −1.55]. Alanine aminotransferase decreased significantly with seladelpar versus placebo [5 mg: 23.4% (p=0.0008); 10 mg: 16.7% (p=0.03); placebo: 4%]. There were no serious treatment-related adverse events. Conclusions: Patients with primary biliary cholangitis (PBC) with inadequate response or intolerance to UDCA who were treated with seladelpar 10 mg had significant improvements in liver biochemistry and pruritus. Seladelpar appeared safe and well tolerated.
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In the ENHANCE trial, the proportion of patients who achieved ALP < 1.67 × ULN at 3 months was higher in the 10 mg seladelpar group (95%) and the 5 mg seladelpar group (95%), compared to placebo (23%) (p < 0.0001 in both comparisons).
“The proportion of patients who achieved ALP < 1.67 × ULN at 3 months was higher in the 10 mg seladelpar group (95%) and the 5 mg seladelpar group (95%), compared to placebo (23%) (p < 0.0001 in both comparisons).”
From Second-Line Therapies in Primary Biliary Cholangitis: A Comparative Review of Obeticholic Acid, Fibrates, Seladelpar, and Elafibranor (2025) · cites this paper as [16]
The Results > Efficacy passage reports that 18% of placebo patients, 64% of the 5-mg group, and 82% of the 10-mg group achieved ALP <1.67×ULN at month 3. The claimed 23%, 95%, and 95% are instead the percentages who achieved a ≥15% decrease in ALP from baseline. The cited passage does not give p-values for the individual ALP <1.67×ULN comparison. (LLM, conf=0.95)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measuredThe 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 [16]
In Results > Safety, Table 2 reports nausea, upper abdominal pain, and headache more often in both seladelpar groups than in the placebo group. The paper does not specify that the reported headaches were mild; its statement that all treatment-related adverse events were grade 1 or 2 does not establish the severity of every reported headache. Page numbers are unavailable in our copy. (LLM, conf=0.86)
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 [16]
The Results > Safety section reports broadly comparable adverse-event rates for seladelpar and placebo during this study, though the rates were not identical (62.9% and 65.2% versus 73.6%). The Discussion identifies short duration as a limitation and cites phase 2 data suggesting safety through one year, but it does not provide a long-term placebo comparison. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIn the ENHANCE trial, ALT decrease from baseline was reported as −16.7% in seladelpar 10 mg (p < 0.03) and −23.4% in seladelpar 5 mg (p = 0.0008) when compared to placebo of −4.0%.
“ALT decrease from baseline was reported as −16.7% in seladelpar 10 mg (p < 0.03) and −23.4% in seladelpar 5 mg (p = 0.0008) when compared to placebo of −4.0% [16].”
From Second-Line Therapies in Primary Biliary Cholangitis: A Comparative Review of Obeticholic Acid, Fibrates, Seladelpar, and Elafibranor (2025) · cites this paper as [16]
The Results > Efficacy passage reports month-3 ALT reductions of 16.7% with seladelpar 10 mg, 23.4% with 5 mg, and 4.0% with placebo. The Abstract > Approach and Results gives p=0.0008 for 5 mg versus placebo, but reports p=0.03—not p<0.03—for 10 mg. (LLM, conf=0.87)
Experimental — accuracy not yet measuredIn the ENHANCE trial, the mean pruritus NRS change was −2.01 in seladelpar 5 mg (p = 0.48) and −3.14 in 10 mg (p = 0.02) when compared to −1.55 placebo.
“The mean pruritis NRS change was −2.01 in seladelpar 5 mg (p = 0.48) and −3.14 in 10 mg (p = 0.02) when compared to −1.55 placebo.”
From Second-Line Therapies in Primary Biliary Cholangitis: A Comparative Review of Obeticholic Acid, Fibrates, Seladelpar, and Elafibranor (2025) · cites this paper as [16]
The Results > Efficacy passage reports all three changes and p-values at month 3. However, these figures apply only to evaluable patients with moderate-to-severe pruritus at baseline (NRS ≥4), a restriction the citing sentence omits. (LLM, conf=0.86)
Experimental — accuracy not yet measured
Seladelpar and elafibranor have demonstrated favorable biochemical efficacy, safety, and tolerability, particularly in terms of pruritus improvement, and have recently gained FDA approval.
“In summary, second-line therapies for PBC have evolved significantly, with several promising agents emerging beyond OCA. Seladelpar and elafibranor have demonstrated favorable biochemical efficacy, safety, and tolerability, particularly in terms of pruritus improvement, and have recently gained FDA approval.”
From Second-Line Therapies in Primary Biliary Cholangitis: A Comparative Review of Obeticholic Acid, Fibrates, Seladelpar, and Elafibranor (2025) · cites this paper as [16]
The Results and Discussion (page not provided) support biochemical efficacy, tolerability, and improved pruritus with seladelpar, particularly at 10 mg in patients with moderate-to-severe baseline itch. The Discussion mentions elafibranor only as a therapy in development with reported biochemical response; it does not establish its safety or pruritus benefit. The paper does not support the claim that either drug had recently gained FDA approval. (LLM, conf=0.90)
Experimental — accuracy not yet measuredThere 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 [16]
In the ENHANCE trial, among patients analyzed at 3 months, 78.2% of those who received seladelpar 10 mg and 57.1% of those who received seladelpar 5 mg achieved a composite biochemical response, compared to 12.5% in the placebo group (p < 0.0001).
“Among the patients analyzed at 3 months, 78.2% of those who received seladelpar 10 mg (n = 55) and 57.1% of those who received seladelpar 5 mg (n = 56) achieved a composite biochemical response, compared to only 12.5% in the placebo group (n = 56) (p < 0.0001).”
From Second-Line Therapies in Primary Biliary Cholangitis: A Comparative Review of Obeticholic Acid, Fibrates, Seladelpar, and Elafibranor (2025) · cites this paper as [16]
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 [16]
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 [16]
Seladelpar (PPAR-δ selective) consistently improves pruritus and shows high biochemical response rates, while elafibranor (dual PPAR-α/δ) improves biochemical endpoints with a neutral pruritus effect but a reassuring safety signal overall.
“On the other hand, seladelpar (PPAR-δ selective) consistently improves pruritus and shows high biochemical response rates, while elafibranor (dual PPAR-α/δ) improves biochemical endpoints with a neutral pruritus effect but a reassuring safety signal overall [16,50].”
From Second-Line Therapies in Primary Biliary Cholangitis: A Comparative Review of Obeticholic Acid, Fibrates, Seladelpar, and Elafibranor (2025) · cites this paper as [16]
The RCT of seladelpar (10 mg daily) showed significant improvement in pruritus.
“the RCT of seladelpar (10 mg daily) showed significant improvement in pruritus.100”
From Primary biliary cholangitis. (2024) · cites this paper as [100]
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Drug‐Induced Liver Injury in Patients With Chronic Liver Disease
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Self-citationTwo sides of the same coin: Non-alcoholic fatty liver disease and atherosclerosis
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Self-citationItching for Answers: A Comprehensive Review of Cholestatic Pruritus Treatments
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Cholestatic Pruritus: Pathophysiology, Current Management Approach, and Emerging Therapies
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The Treatment of Primary Biliary Cholangitis: Time for Personalized Medicine
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Self-citationPersistent pruritus associated with worse quality of life in patients with chronic hepatitis
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Evaluating the safety and efficacy of seladelpar for adults with primary biliary cholangitis
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Review Article: Targeting Peroxisome Proliferator‐Activated Receptors in Primary Biliary Cholangitis
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Self-citationRevisiting PPAR agonists: novel perspectives in the treatment of primary biliary cholangitis
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Review of Current and Upcoming Second-Line Treatments for Primary Biliary Cholangitis
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A comprehensive review of small molecule drugs approved by the FDA in 2025: advance and prospect
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Reviewing novel findings and advances in diagnoses and treatment of primary biliary cholangitis
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Meta‐Analysis: PPAR Agonists for Pruritus and Quality of Life in Primary Biliary Cholangitis
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Self-citationA comprehensive review of small molecule drugs approved by the FDA in 2024: Advance and prospect
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Managing pruritus in chronic liver disease: An in-depth narrative review
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Self-citationPPARα, PPARδ, or both—that is the question!
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Risk factors and prediction for DILI in clinical practice
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Self-citationUp-to-Date Snapshot of Current and Emerging Medical Therapies in Primary Biliary Cholangitis
Warsop, Z. I., Anand, N., Maliki, H. A., Souza, S. D., Kamyab, A. A., Hadad, A. A., & Alrubaiy, L. (2024) · Journal of Personalized Medicine · doi:10.3390/jpm14121133 · Cited by 3 · see citing works
Editorial: The evolving paradigms and treatments for primary biliary cholangitis
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Self-citationEvolving Concepts of Treatment Targets for Primary Biliary Cholangitis: A Global Perspective
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Validation of PBC‐10 in Japanese patients with primary biliary cholangitis
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POLÍTICAS PÚBLICAS E O DESAFIO DO ACESSO AO TRATAMENTO PARA PACIENTES COM DOENÇAS RARAS
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Single and Multiple Doses of Seladelpar Decrease Diurnal Markers of Bile Acid Synthesis in Mice
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Primary biliary cholangitis: progress and gaps in diagnosis and treatment
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- Authors
- Hirschfield, G. M., Shiffman, M. L., Gulamhusein, A., Kowdley, K. V., Vierling, J. M., Levy, C., Kremer, A. E., Zigmond, E., Andreone, P., Gordon, S. C., Bowlus, C. L., Lawitz, E. J., Aspinall, R. J., Pratt, D. S., Raikhelson, K., Gonzalez-Huezo, M. S., Heneghan, M. A., Jeong, S.-H., Ladrón de Guevara, A. L., Mayo, M. J., Dalekos, G. N., Drenth, J. P. H., Janczewska, E., Leggett, B. A., Nevens, F., Vargas, V., Zuckerman, E., Corpechot, C., Fassio, E., Hinrichsen, H., Invernizzi, P., Trivedi, P. J., Forman, L., Jones, D. E. J., Ryder, S. D., Swain, M. G., Steinberg, A., Boudes, P. F., Choi, Y.-J., McWherter, C. A., & ENHANCE Study Group*
- Affiliations
- University Health Network (CA)
- Tampa General Hospital (US)
- Liver Institute Northwest (US)
- Baylor College of Medicine (US)
- University of Miami (US)
- University Hospital Zurich (CH)
- Cedars-Sinai Medical Center (US)
- Department of Medical and Surgical Sciences, Division of Internal Medicine, Maternal-Infantile and Adult, University of Modena and Reggio Emilia, Modena, Italy
- Wayne State University (US)
- Hospital Universitari i Politècnic La Fe (ES)
- The University of Texas at San Antonio Health Science Center (US)
- National Health Service (GB)
- Beth Israel Deaconess Medical Center (US)
- St Petersburg University (RU)
- Metepec Edo Mex., Mexico
- Seoul National University Bundang Hospital (KR)
- Center of Research and Gastroenterology, Mexico City, Mexico
- The University of Texas Southwestern Medical Center (US)
- Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Center of Greece in Autoimmune Liver Diseases, European Reference Network on Hepatological Diseases (ERN RARE-LIVER), General University Hospital of Larissa, Larissa, Greece
- Radboud University Nijmegen (NL)
- Medical University of Silesia (PL)
- The University of Queensland (AU)
- Liver Unit, Hospital Universitari Vall d’Hebron, Universitat Autònoma de Barcelona, Bellaterra, Spain
- Technion – Israel Institute of Technology (IL)
- Inserm (FR)
- Zemun Hospital (RS)
- Canberra Hospital (AU)
- Azienda Ospedale - Università Padova (IT)
- Queen Elizabeth Hospital Birmingham (GB)
- University of Colorado Anschutz (US)
- National Institute for Health and Care Research (GB)
- University of Calgary (CA)
- CymaBay Therapeutics (United States) (US)
- Intermountain Medical Center (US)
- Stanford Medicine (US)
- Corresponding author
- Hirschfield, Gideon M.
- ORCID
- Hirschfield, Gideon M.
- Shiffman, Mitchell L.
- Gulamhusein, Aliya
- Kowdley, Kris V.
- Vierling, John M.
- Levy, Cynthia
- Kremer, Andreas E.
- Zigmond, Ehud
- Andreone, Pietro
- Gordon, Stuart C.
- Bowlus, Christopher L.
- Lawitz, Eric J.
- Aspinall, Richard J.
- Pratt, Daniel S.
- Raikhelson, Karina
- Gonzalez-Huezo, Maria S.
- Heneghan, Michael A.
- Jeong, Sook-Hyang
- Ladrón de Guevara, Alma L.
- Mayo, Marlyn J.
- Dalekos, George N.
- Drenth, Joost P.H.
- Janczewska, Ewa
- Leggett, Barbara A.
- Nevens, Frederik
- Vargas, Victor
- Corpechot, Christophe
- Fassio, Eduardo
- Invernizzi, Pietro
- Trivedi, Palak J.
- Forman, Lisa
- Ryder, Stephen D.
- Swain, Mark G.
- Steinberg, Alexandra
- Boudes, Pol F.
- Choi, Yun-Jung
- McWherter, Charles A.
- Venue
- Hepatology
- Published
- 2023-04-06
- Volume
- 78
- Issue
- 2
- Pages
- 397-415
- ISSN
- 0270-9139 (ISSN-L)
- PMC
- PMC10344437
- OpenAlex
- W4362619875
- Cited by
- 127
- References
- 39
- Citations by year
- 2026: 28 · 2025: 46 · 2024: 41 · 2023: 12
- FWCI
- 21.47
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Hepatology (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Zurich Open Repository and Archive (University of Zurich) (acceptedVersion, cc-by-nc-nd)
- Ghent University Academic Bibliography (Ghent University) (submittedVersion, cc-by)
- Dipòsit Digital de Documents de la UAB (Universitat Autònoma de Barcelona) (submittedVersion, cc-by)
- UCL Discovery (University College London) (submittedVersion, cc-by)
- eScholarship (California Digital Library) (submittedVersion, cc-by)
- IRIS UNIMORE (University of Modena and Reggio Emilia) (submittedVersion, cc-by)
- Lirias (KU Leuven) (submittedVersion, cc-by)
- Radboud Repository (Radboud University) (submittedVersion)
- Digital Commons-TMC (Texas Medical Center) (submittedVersion)
- BOA (University of Milano-Bicocca) (submittedVersion)
- Zurich Open Repository and Archive (University of Zurich) (submittedVersion, cc-by)
- Zurich Open Repository and Archive (University of Zurich)
- Funders
- U.S. Department of Justice
- Abbott Laboratories
- Amgen
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- Gilead Sciences
- Alnylam Pharmaceuticals
- Celgene
- Cook Medical
- Exelixis
- BioCryst
- Kowa Company
- NGM Biopharmaceuticals
- Moderna
- National Institute for Health and Care Research (NIHR200243, NF-SI-0513-10091)
- Eisai
- Novo Nordisk
- Swedish Orphan Biovitrum
- Ipsen
- AOP Orphan
- Dr. Falk Pharma
- Norgine
- Genentech
- Allergan
- Novartis Pharma
- Loxo Oncology
- Janssen Pharmaceuticals
- Cilag
- Topics
- Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
- Health Sciences › Medicine › Oncology › Drug Transport and Resistance Mechanisms
- Health Sciences › Medicine › Surgery › Pediatric Hepatobiliary Diseases and Treatments
- Keywords
- seladelpar, primary biliary cirrhosis, PPARδ agonist, pruritus, alanine aminotransferase, biochemical response, drug safety, early trial termination, ENHANCE trial, dose comparison, treatment-naive patients
- MeSH terms
- Acetates, Alkaline Phosphatase, Cholagogues and Choleretics, Humans, Liver Cirrhosis, Biliary, Pruritus, Ursodeoxycholic Acid
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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.
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