Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects With Primary Biliary Cholangitis
Public ClinicalTrials.gov record NCT05104853. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2a Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-104 in Subjects Ages 18-75 With Primary Biliary Cholangitis Who Are Unresponsive to UDCA and/or OCA
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is a Phase 2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-104. The study consists of a 120 day primary study followed by a 20 month long-term safety and durability of response follow-up period.
Study identification
- NCT ID
- NCT05104853
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 42 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 25, 2022 (Actual)
- Primary completion
- Jan 30, 2026 (Actual)
- Completion
- Jan 30, 2026 (Actual)
- Last update posted
- Mar 10, 2026
2022 – 2026
United States locations
- U.S. sites
- 19
- U.S. states
- 13
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southern California Research Center | Coronado | California | 92118 | — |
| OM Research | Lancaster | California | 93534 | — |
| University of California Davis Health | Sacramento | California | 95817 | — |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80907 | — |
| Yale School of Medicine | New Haven | Connecticut | 06520 | — |
| University of Florida - Hepatology Research | Gainesville | Florida | 32610 | — |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | — |
| Florida Research Institute | Lakewood Rch | Florida | 34211-4930 | — |
| GI PROS Research | Naples | Florida | 34102 | — |
| Cleveland Clinic - Florida | Weston | Florida | 33331 | — |
| Digestive Healthcare of Georgia | Atlanta | Georgia | 30309 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Henry Ford Health System | Novi | Michigan | 48377 | — |
| Washington University School of Medicine in St. Louis | St Louis | Missouri | 63110 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Texas Liver Institute | San Antonio | Texas | 78215 | — |
| University of Virginia | Charlottesville | Virginia | 22903 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05104853, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 10, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05104853 live on ClinicalTrials.gov.