Trial · NCT02955602
Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)
NCT02955602, Phase 2, Completed, Gilead Sciences; results first posted 2022-07-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC). Trials, record NCT02955602. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02955602
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)
- NCT number
- NCT02955602
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 119 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Primary Biliary Cirrhosis
- Interventions
- MBX-8025 2 mg Capsule, MBX-8025 5 mg Capsule, MBX-8025 10 mg Capsule
- First posted
- 2016-11-04
- Last updated
- 2022-07-14
- Results first posted
- 2022-07-14
- Limitations and caveats
First, there was an imbalance in baseline ALP levels among cohorts. Second, the criteria for dose uptitration were not standardized, except that uptitration could only be done at or after Week 12. Third, this was not a placebo-controlled study. Finally, multiplicity adjustments were not made for efficacy endpoints. Nominal p-values were provided for descriptive purposes.
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Relative Change From Baseline in Serum Alkaline Phosphatase (ALP) at Week 8 | 8 weeks | Relative change from baseline in serum ALP levels at Week 8 (endpoint). The modified Intent-to-Treat (mITT) analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment. n, denotes number of subjects evaluable for the respective timepoints |
| Secondary | Absolute Change From Baseline in Serum Alkaline Phosphatase (ALP) at Week 12 and Week 52 | 12 weeks and 52 weeks | Absolute change in ALP from baseline to Weeks 12 and 52 The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment. |
| Secondary | Change in Aspartate Aminotransferase (AST) From Baseline to 12 Weeks and 52 Weeks | 12 weeks and 52 weeks | Change from baseline in AST levels at endpoint was reported. The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment. |
| Secondary | Change in Alanine Aminotransferase (ALT) From Baseline to 12 Weeks and 52 Weeks | 12 weeks and 52 weeks | Change from baseline in ALT levels at endpoint was reported. The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment. |
| Secondary | Change in Gamma-glutamyl Transferase (GGT) From Baseline to 12 Weeks and 52 Weeks | 12 weeks and 52 weeks | Change from baseline in GGT levels at endpoint was reported. The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment. |
| Secondary | Change in Bilirubin - Total Bilirubin (TB) From Baseline to 12 Weeks and 52 Weeks | 12 weeks and 52 weeks | Change from baseline in TB levels at endpoint is being reported. The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment. |
| Secondary | Percentage of Participants Meet Composite Endpoint Criteria of ALP and Total Bilirubin | 12 Weeks and 52 Weeks | Participant meets composite endpoint is defined by participant meets all of the following criteria: * ALP \< 1.67 × upper limit of normal (ULN) * Total Bilirubin within normal limit * \> 15% decrease in ALP Endpoint of Alkaline Phosphatase and Total Bilirubin by Visit (mITT Population) |
| Secondary | Percentage of Participants Meet Published PBC Response Criteria - Paris I | 12 weeks and 52 weeks | Percentage of participants with response based on Paris I risk score was defined as ALP less than or equal to (≤) 3x ULN and aspartate aminotransferase (AST) less than or equal to (≤) 2 x ULN and Total Bilirubin ≤ 1 mg/dL. The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment. |
| Secondary | Percentage of Participants Meet Published PBC Response Criteria - Paris II | 12 weeks and 52 weeks | Percentage of participants with response based on Paris II risk score was defined as ALP≤1.5xULN and AST≤1.5xULN and Total Bilirubin ≤ 1 mg/dL. The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment. |
| Secondary | Percentage of Participants Meet Published PBC Response Criteria - Toronto I | 12 weeks and 52 weeks | Percentage of participants with response based on Toronto I risk score defined as ALP ≤ 1.67 x ULN. The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Relative Change From Baseline in Serum Alkaline Phosphatase (ALP) at Week 8 | 8 weeks | mITT Population The mITT population is defined as any enrolled subject who receives at least one dose of medication and has at least one post-baseline AP evaluation and who have confirmed PBC. | percentage change from baseline | MEAN |
| SECONDARY | Absolute Change From Baseline in Serum Alkaline Phosphatase (ALP) at Week 12 and Week 52 | 12 weeks and 52 weeks | mITT Population: The mITT population is defined as any enrolled subject who receives at least one dose of medication and has at least one post-baseline AP evaluation and who have confirmed PBC. | U/L | MEAN |
| SECONDARY | Change in Aspartate Aminotransferase (AST) From Baseline to 12 Weeks and 52 Weeks | 12 weeks and 52 weeks | mITT Population The mITT population is defined as any enrolled subject who receives at least one dose of medication and has at least one post-baseline AP evaluation and who have confirmed PBC. | U/L | MEAN |
| SECONDARY | Change in Alanine Aminotransferase (ALT) From Baseline to 12 Weeks and 52 Weeks | 12 weeks and 52 weeks | mITT Population The mITT population is defined as any enrolled subject who receives at least one dose of medication and has at least one post-baseline AP evaluation and who have confirmed PBC. | U/L | MEAN |
| SECONDARY | Change in Gamma-glutamyl Transferase (GGT) From Baseline to 12 Weeks and 52 Weeks | 12 weeks and 52 weeks | mITT Population The mITT population is defined as any enrolled subject who receives at least one dose of medication and has at least one post-baseline AP evaluation and who have confirmed PBC. | U/L | MEAN |
| SECONDARY | Change in Bilirubin - Total Bilirubin (TB) From Baseline to 12 Weeks and 52 Weeks | 12 weeks and 52 weeks | mITT Population The mITT population is defined as any enrolled subject who receives at least one dose of medication and has at least one post-baseline AP evaluation and who have confirmed PBC. | mg/dL | MEAN |
| SECONDARY | Percentage of Participants Meet Composite Endpoint Criteria of ALP and Total Bilirubin | 12 Weeks and 52 Weeks | mITT Population The mITT population is defined as any enrolled subject who receives at least one dose of medication and has at least one post-baseline AP evaluation and who have confirmed PBC. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Meet Published PBC Response Criteria - Paris I | 12 weeks and 52 weeks | mITT Population The mITT population is defined as any enrolled subject who receives at least one dose of medication and has at least one post-baseline AP evaluation and who have confirmed PBC. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Meet Published PBC Response Criteria - Paris II | 12 weeks and 52 weeks | mITT Population. The mITT population is defined as any enrolled subject who receives at least one dose of medication and has at least one post-baseline AP evaluation and who have confirmed PBC. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Meet Published PBC Response Criteria - Toronto I | 12 weeks and 52 weeks | mITT Population. The mITT population is defined as any enrolled subject who receives at least one dose of medication and has at least one post-baseline AP evaluation and who have confirmed PBC. | percentage of subjects | NUMBER |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group165
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Relative Change From Baseline in Serum Alkaline Phosphatase (ALP) at Week 8 | MBX-8025 (2 mg) | -26.06 | Standard Deviation 9.15 | percentage change from baseline | |
| Relative Change From Baseline in Serum Alkaline Phosphatase (ALP) at Week 8 | MBX-8025 (5 mg) | -33.38 | Standard Deviation 17.81 | percentage change from baseline | |
| Relative Change From Baseline in Serum Alkaline Phosphatase (ALP) at Week 8 | MBX-8025 (10 mg) | -41.42 | Standard Deviation 13.05 | percentage change from baseline | |
| Absolute Change From Baseline in Serum Alkaline Phosphatase (ALP) at Week 12 and Week 52 | MBX-8025 (2 mg) | Absolute Change at Week 12 | -68.318 | Standard Deviation 63.276 | U/L |
| Absolute Change From Baseline in Serum Alkaline Phosphatase (ALP) at Week 12 and Week 52 | MBX-8025 (5 mg) | Absolute Change at Week 12 | -135.902 | Standard Deviation 150.954 | U/L |
| Absolute Change From Baseline in Serum Alkaline Phosphatase (ALP) at Week 12 and Week 52 | MBX-8025 (10 mg) | Absolute Change at Week 12 | -127.867 | Standard Deviation 60.284 | U/L |
| Absolute Change From Baseline in Serum Alkaline Phosphatase (ALP) at Week 12 and Week 52 | MBX-8025 (2 mg) | Absolute Change at Week 52 | -101.150 | Standard Deviation 107.956 | U/L |
| Absolute Change From Baseline in Serum Alkaline Phosphatase (ALP) at Week 12 and Week 52 | MBX-8025 (5 mg) | Absolute Change at Week 52 | -158.310 | Standard Deviation 143.668 | U/L |
| Absolute Change From Baseline in Serum Alkaline Phosphatase (ALP) at Week 12 and Week 52 | MBX-8025 (10 mg) | Absolute Change at Week 52 | -133.760 | Standard Deviation 76.151 | U/L |
| Change in Aspartate Aminotransferase (AST) From Baseline to 12 Weeks and 52 Weeks | MBX-8025 (2 mg) | Week 12 | -2.50 | Standard Deviation 16.72 | U/L |
1 to 10 of 165Source ClinicalTrials.gov
See all 165 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MBX-8025 (2 mg) | 11 | |
| Overall Study | STARTED | MBX-8025 (5 mg) | 53 | |
| Overall Study | STARTED | MBX-8025 (10 mg) | 55 | |
| Overall Study | COMPLETED | MBX-8025 (2 mg) | 10 | |
| Overall Study | COMPLETED | MBX-8025 (5 mg) | 46 | |
| Overall Study | COMPLETED | MBX-8025 (10 mg) | 49 | |
| Overall Study | NOT COMPLETED | MBX-8025 (2 mg) | 1 | |
| Overall Study | NOT COMPLETED | MBX-8025 (5 mg) | 7 | |
| Overall Study | NOT COMPLETED | MBX-8025 (10 mg) | 6 |
Source ClinicalTrials.gov
Adverse events267
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | MBX-8025 2 mg | 0 | 11 | 0 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | MBX-8025 5 mg | 3 | 53 | 3 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | MBX-8025 10 mg | 0 | 55 | 0 |
| other | Palpitations | Cardiac disorders | MBX-8025 2 mg | 1 | 11 | 1 |
| other | Palpitations | Cardiac disorders | MBX-8025 5 mg | 2 | 53 | 2 |
| other | Palpitations | Cardiac disorders | MBX-8025 10 mg | 2 | 55 | 2 |
| other | Dry eye | Eye disorders | MBX-8025 2 mg | 2 | 11 | 2 |
| other | Dry eye | Eye disorders | MBX-8025 5 mg | 1 | 53 | 1 |
| other | Dry eye | Eye disorders | MBX-8025 10 mg | 4 | 55 | 4 |
| other | Abdominal discomfort | Gastrointestinal disorders | MBX-8025 2 mg | 1 | 11 | 1 |
1 to 10 of 267Source ClinicalTrials.gov
See all 267 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MBX-8025 2 mg | 0 | 11 |
| Total, all-cause mortality | MBX-8025 5 mg | 0 | 53 |
| Total, all-cause mortality | MBX-8025 10 mg | 0 | 55 |
| Total, other adverse events | MBX-8025 2 mg | 11 | 11 |
| Total, other adverse events | MBX-8025 5 mg | 45 | 53 |
| Total, other adverse events | MBX-8025 10 mg | 47 | 55 |
| Total, serious adverse events | MBX-8025 2 mg | 1 | 11 |
| Total, serious adverse events | MBX-8025 5 mg | 8 | 53 |
| Total, serious adverse events | MBX-8025 10 mg | 5 | 55 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35367282 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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