Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Study of Auxora in Patients With Acute Pancreatitis and Accompanying SIRS
NCT04681066 · View on ClinicalTrials.gov ↗
Study Summary
Approximately 216 patients with acute pancreatitis and accompanying SIRS will be randomized at approximately 30 sites. Patients will be randomly assigned to either Auxora at one of three dose levels or one of three placebo volumes to maintain the double-blind. Study drug infusions will occur every 24 hours for three consecutive days for a total of three infusions. Patients will remain hospitalized as per standard of care and once discharged will be asked to complete a daily meal diary and return for a Day 30 safety assessment. It is recommended that patients randomized in the study should not be discharged from the hospital until solid food is tolerated, abdominal pain has resolved or been adequately controlled, and there is no clinical evidence of infection necessitating continued hospitalization.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG CM-4620 Injectable Emulsion or CM-4620-IE
Study Locations (20)
California
- Long Beach Medical Center — Long Beach
- LA County Hospital - USC — Los Angeles
- Cedars Sinai — Los Angeles
- University of California at Irvine Medical Center — Orange
- Harbor UCLA Medical Center — Torrance
- Torrance Memorial Medical Center — Torrance
Florida
- Sarasota Memorial Health Care System — Sarasota
- Tampa General Hospital — Tampa
Minnesota
- Methodist Hospital — Saint Louis Park
- Regions Hospital — Saint Paul
Missouri
- University of Missouri School of Medicine — Columbia
- Washington University School of Medicine — St Louis
New York
- Northshore University Hospital — Manhasset
- Icahn School of Medicine at Mount Sinai — New York
Connecticut
- The Stamford Hospital — Stamford
Idaho
- St. Luke's Regional Medical Center — Boise
Illinois
- Northwestern University Hospital — Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 216 participants |
| Start Date | 2021-03-24 |
| Est. Completion | 2024-05-15 |
| Phase | Phase 2 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04681066
The ClinicalTrials.gov registry entry for NCT04681066 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 216 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CalciMedica, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Acute Pancreatitis appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04681066 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Florida, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04681066 about?
NCT04681066 is a clinical study titled "A Study of Auxora in Patients With Acute Pancreatitis and Accompanying SIRS". Approximately 216 patients with acute pancreatitis and accompanying SIRS will be randomized at approximately 30 sites. Patients will be randomly assigned to either Auxora at one of three dose levels or one of three placebo volumes to maintain the double-blind. Study drug infusions will occur every 2...
What is the current status of trial NCT04681066?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 216 participants. The study started on 2021-03-24. Estimated completion is 2024-05-15.
What conditions does trial NCT04681066 study?
This clinical trial studies the following conditions: Acute Pancreatitis, Systemic Inflammatory Response Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04681066?
The interventions under investigation include: Placebo (OTHER), CM-4620 Injectable Emulsion or CM-4620-IE (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04681066?
This trial is sponsored by CalciMedica, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04681066 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Idaho, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.