A Phase 2 interventional study of CM4620 Injectable Emulsion (Low Dose) and CM4620 Injectable Emulsion (High Dose) in Acute Pancreatitis and Systemic Inflammatory Response Syndrome, sponsored by CalciMedica, Inc.. Completed at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by CalciMedica, Inc. · Phase 2, Interventional, and Treatment
This open-label, dose-response study will evaluate the safety and efficacy of CM4620-IE in patients with acute pancreatitis and accompanying SIRS. The study will consist of two phases. The first phase will consist of 4 female and 4 male patients (cohorts 1 and 2, respectively), enrolled concurrently, randomized in a 3:1 ratio to receive CM4620-IE plus standard of care versus standard of care alone. Planned doses for first phase will be CM4620-IE 1.0 mg/kg on Day 1 and then 1.4 mg/kg on Days 2 - 4.
The second phase will consist of 8 female and 8 male patients (cohorts 3 and 4, respectively), enrolled concurrently, randomized in a 3:1 ratio to receive CM4620-IE plus standard of care versus standard of care alone. Planned doses for second phase will be CM4620-IE 2.08 mg/kg on Days 1 and 2 and then 1.6 mg/kg on Days 3 and 4. Dose escalation to second phase would only occur if needed for efficacy reasons and if no events suggesting a safety signal would occur with higher dosing.
The study is not powered for the analysis of study data with inferential statisitcs as the primary purpose of the study is to explore what endpoints would be most appropriate for future trials.
After review of the efficacy, tolerability and safety data from cohorts 1 and 2 by the sponsor and the United States Food and Drug Administration, the decision was made to continue the low-dose regimen (CM4620-IE 1.0 mg/kg on Day 1 and then 1.4 mg/kg on Days 2 - 4) in cohort 3. Cohort 4 received the high-dose regimen (CM4620-IE 2.08 mg/kg on Days 1 and 2 and then 1.6 mg/kg on Days 3 and 4) as planned. Efficacy analysis were combined because no dose escalation occurred in cohort 3.
Patients were followed for 90 days after randomization.
557 studies on the registry are indexed under Pancreatitis; 164 are open to participants now.
This study's enrollment of 21 is below the median of 100 across 349 interventional studies indexed under Pancreatitis.
Browse Pancreatitis studies →CalciMedica, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of acute pancreatitis established by the presence of abdominal pain consistent with acute pancreatitis and 1 of the following 2 criteria:
Diagnosis of SIRS, defined by the presence of at least 2 of the following 4 criteria:
Exclusion Criteria:
History of:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Phase 1: Cohorts 1 \& 2 will consist of 4 female and 4 male patients enrolled concurrently who will be randomized 3:1 to receive CM4620-IE plus standard of care versus standard of care alone. Planned doses for patients who are randomized to receive CM4620-IE are 1.0 mg/kg on Days 1 and 1.4 mg/kg on Days 2-4.
Drug: CM4620 Injectable Emulsion (Low Dose)
Phase 2: Cohorts 3 \& 4 will consist of 8 female and 8 male patients enrolled concurrently who will be randomized 3:1 to receive CM4620-IE plus standard of care versus standard of care alone. Planned doses for patients who are randomized to receive CM4620-IE are 2.08 mg/kg of CM4620-IE on Days 1 and 2, and 1.6 mg/kg on Days 3 and 4.
Drug: CM4620 Injectable Emulsion (High Dose)
For all cohorts, patients will be randomized 3:1 to CM4620-IE plus standard of care versus standard of care alone.
CM4620-IE 1.0 mg/kg on Day 1 and then 1.4 mg/kg on Days 2-4, during the first phase of the study (Cohorts 1 and 2). All doses of CM4620-IE will be administered intravenously (IV) over 4 hours.
Also known as: CM4620-IE (Low Dose)
CM4620-IE 2.08 mg/kg on Days 1 and 2 and then 1.6 mg/kg on Days 3 and 4, during the second phase of the study (Cohorts 3 and 4). All doses of CM4620-IE will be administered intravenously (IV) over 4 hours.
Also known as: CM4620-IE (High Dose)
The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia.
Safety and tolerability will be assessed by monitoring the frequency, duration and severity of treatment-emergent adverse events (TEAEs) throughout the study period.
Time frame: 90 Days
The Number of Patients With a Change in Computed Tomography Severity Index (CTSI) Score Between Screening and Day 5 (or Discharge, if Earlier)
CTSI score measures abnormal pancreatic morphology and is the sum of two subscales. The Balthazar subscale rates pancreatic CT image findings on a scale of 0 (normal) to 4 (2 or more peri-pancreatic fluid collections. The Pancreatic Necrosis subscale rates pancreatic necrosis from 0 (none) to 6 (\>50%). The two subscales are summed for a CTSI score of 0-3 (mild AP), 4-6 (moderate AP), and 7-10 (severe AP).
Time frame: 5 days (or discharge, if earlier)
The Number of Patients Tolerating Solid Food
Defined as eating ≥ 50% of a solid meal without vomiting or an increase in pain
Time frame: at 72 hours (or discharge, if earlier)
The Number of Patients Tolerating Solid Food
Defined as eating ≥ 50% of a solid meal without vomiting or an increase in pain
Time frame: at Day 10 (or discharge, if earlier)
Percentage of Patients With Persistent Systemic Inflammatory Response Syndrome (SIRS)
The presence of SIRS was defined as the presence of at least 2 of the following 4 criteria: * Temperature \< 36°C or \> 38°C; * Heart rate \> 90 beats/minute; * Respiratory rate \> 20 breaths/minute or arterial carbon dioxide tension (PaCO2) \< 32 mmHg; * White blood cell count (WBC) \> 12,000 cells/mm3 or \< 4,000 cells/mm3 or \> 10% immature (band) forms. * The SIRS score was determined at Screening, prior to randomization, and every 12 hours until Day 6, after which it was determined every 24 hours.
Time frame: ≥ 48 hours
IL-6 Values in Patients With a Maximum IL-6 Value ≥ 150 pg/mL in the First 24 Hours
Assess blood serum samples to be analyzed for interleuken (IL-6) llevels pg/mL collected in the first 24 hours and daily thereafter. Samples were sent to the central laboratory. The results were not provided to the Principal Investigator or treating physician.
Time frame: Day 10 (or discharge, if earlier)
Median Days in Hospital
Length of stay in hospital in days (randomization to discharge)
Time frame: discharge
| Milestone | Low Dose Group | High Dose Group | Standard of Care Group |
|---|---|---|---|
| Started | 8 | 6 | 7 |
| Completed | 8 | 4 | 7 |
| Not completed | 0 | 2 | 0 |
Safety and tolerability will be assessed by monitoring the frequency, duration and severity of treatment-emergent adverse events (TEAEs) throughout the study period.
| Participants | Low Dose Group + SC | High Dose Group + SC | Standard of Care Group (SC) |
|---|---|---|---|
| TEAE patients | 7 | 5 | 3 |
| Severe TEAE patients | 0 | 2 | 2 |
| SAE patients | 2 | 1 | 2 |
| TEAEs leading to discontinuation | 0 | 2 | 0 |
| TEAEs leading to death | 0 | 1 | 0 |
| Treatment-related TEAEs | 0 | 1 | 0 |
CTSI score measures abnormal pancreatic morphology and is the sum of two subscales. The Balthazar subscale rates pancreatic CT image findings on a scale of 0 (normal) to 4 (2 or more peri-pancreatic fluid collections. The Pancreatic Necrosis subscale rates pancreatic necrosis from 0 (none) to 6 (\>50%). The two subscales are summed for a CTSI score of 0-3 (mild AP), 4-6 (moderate AP), and 7-10 (severe AP).
| Participants | Low Dose Group + SC | High Dose Group + SC | Standard of Care Group (SC) |
|---|---|---|---|
| Screening — Number of Patients with Mild AP | 4 | 1 | 2 |
| Screening — Number of Patients with Moderate AP | 4 | 4 | 3 |
| Screening — Number of Patients with Severe AP | 0 | 0 | 1 |
| Day 5 or Discharge, if earlier — Number of Patients with Mild AP | 7 | 1 | 3 |
| Day 5 or Discharge, if earlier — Number of Patients with Moderate AP | 1 | 4 | 3 |
| Day 5 or Discharge, if earlier — Number of Patients with Severe AP | 0 | 0 | 1 |
Defined as eating ≥ 50% of a solid meal without vomiting or an increase in pain
| number of patients tolerating solid food | Low Dose Group + SC | High Dose Group + SC | Standard of Care (SC) |
|---|---|---|---|
| The Number of Patients Tolerating Solid Food | 5 | 2 | 1 |
Defined as eating ≥ 50% of a solid meal without vomiting or an increase in pain
| number of patients tolerating solid food | Low Dose Group + SC | High Dose Group + SC | Standard of Care (SC) |
|---|---|---|---|
| The Number of Patients Tolerating Solid Food | 8 | 5 | 3 |
The presence of SIRS was defined as the presence of at least 2 of the following 4 criteria: * Temperature \< 36°C or \> 38°C; * Heart rate \> 90 beats/minute; * Respiratory rate \> 20 breaths/minute or arterial carbon dioxide tension (PaCO2) \< 32 mmHg; * White blood cell count (WBC) \> 12,000 cells/mm3 or \< 4,000 cells/mm3 or \> 10% immature (band) forms. * The SIRS score was determined at Screening, prior to randomization, and every 12 hours until Day 6, after which it was determined every 24 hours.
| Participants | Low Dose Group + SC | High Dose Group + SC | Standard of Care (SC) |
|---|---|---|---|
| Percentage of Patients With Persistent Systemic Inflammatory Response Syndrome (SIRS) | 1 | 4 | 5 |
Assess blood serum samples to be analyzed for interleuken (IL-6) llevels pg/mL collected in the first 24 hours and daily thereafter. Samples were sent to the central laboratory. The results were not provided to the Principal Investigator or treating physician.
| Participants | Low Dose Group + SC | High Dose Group + SC | Standard of Care Group (SC) |
|---|---|---|---|
| Admission IL-6 Levels — IL-6 ≥ 1000 pg/mL | 0 | 2 | 0 |
| Admission IL-6 Levels — 150 pg/mL ≤ IL-6 < 1000 pg/mL | 4 | 1 | 3 |
| Day 10 or discharge IL-6 Levels — IL-6 ≥ 1000 pg/mL | 0 | 0 | 0 |
| Day 10 or discharge IL-6 Levels — 150 pg/mL ≤ IL-6 < 1000 pg/mL | 0 | 1 | 2 |
Length of stay in hospital in days (randomization to discharge)
| days | Low Dose Group + SC | High Dose Group + SC | Standard of Care Group (SC) |
|---|---|---|---|
| Median Days in Hospital | 3.06 (1.5 to 8.2) | 6.97 (1.8 to 18.3) | 6.02 (1.1 to 30.0) |
Collected over Adverse event data were collected over 90 days after randomization.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Low Dose Group | 0/8 (0%) | 2/8 (25%) | 7/8 (87.5%) |
| High Dose Group | 1/6 (16.7%) | 1/6 (16.7%) | 5/6 (83.3%) |
| Standard of Care Group | 0/7 (0%) | 2/7 (28.6%) | 3/7 (42.9%) |
| Event | Low Dose Group | High Dose Group | Standard of Care Group |
|---|---|---|---|
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 0/8 | 1/6 | 1/7 |
| SepsisInfections and infestations | 0/8 | 1/6 | 0/7 |
| Acute Respiratory Distress SyndromeRespiratory, thoracic and mediastinal disorders | 0/8 | 1/6 | 0/7 |
| Hypoxic-Ischemic EncephalopathyNervous system disorders | 0/8 | 1/6 | 0/7 |
| PneumoniaInfections and infestations | 0/8 | 1/6 | 1/7 |
| Pulseless Electrical ActivityCardiac disorders | 0/8 | 1/6 | 0/7 |
| EncephalopathyNervous system disorders | 0/8 | 0/6 | 1/7 |
| Pneumonia AspirationRespiratory, thoracic and mediastinal disorders | 0/8 | 0/6 | 1/7 |
| Cystitis Non-infectiveRenal and urinary disorders | 1/8 | 0/6 | 0/7 |
| Pancreatitis AcuteGastrointestinal disorders | 1/8 | 0/6 | 0/7 |
| Event | Low Dose Group | High Dose Group | Standard of Care Group |
|---|---|---|---|
| MalnutritionMetabolism and nutrition disorders | 0/8 | 2/6 | 0/7 |
| Confusional statePsychiatric disorders | 0/8 | 2/6 | 1/7 |
| HypokalemiaMetabolism and nutrition disorders | 2/8 | 1/6 | 0/7 |
| HeadacheNervous system disorders | 2/8 | 1/6 | 0/7 |
| Electrolyte imbalanceMetabolism and nutrition disorders | 0/8 | 1/6 | 0/7 |
| Fluid OverloadMetabolism and nutrition disorders | 0/8 | 1/6 | 1/7 |
| Fluid retentionMetabolism and nutrition disorders | 0/8 | 1/6 | 0/7 |
| HyperglycemiaMetabolism and nutrition disorders | 0/8 | 1/6 | 0/7 |
| HypophosphatemiaMetabolism and nutrition disorders | 1/8 | 1/6 | 0/7 |
| AnemiaBlood and lymphatic system disorders | 0/8 | 1/6 | 1/7 |
| Age, Continuous(years) | Low Dose Group | High Dose Group | Standard of Care Group | Total |
|---|---|---|---|---|
| Mean | 50.9 ± 14.7 | 44.3 ± 7.1 | 54.9 ± 10.7 | 48.1 ± 12.1 |
| Sex: Female, Male(Participants) | Low Dose Group | High Dose Group | Standard of Care Group | Total |
|---|---|---|---|---|
| Female | 5 | 0 | 4 | 9 |
| Male | 3 | 6 | 3 | 12 |
| Ethnicity (NIH/OMB)(Participants) | Low Dose Group | High Dose Group | Standard of Care Group | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 0 | 2 |
| Not Hispanic or Latino | 8 | 4 | 7 | 19 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Low Dose Group | High Dose Group | Standard of Care Group | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 3 | 6 |
| White | 6 | 4 | 4 | 14 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Low Dose Group | High Dose Group | Standard of Care Group | Total |
|---|---|---|---|---|
| United States | 8 | 6 | 7 | 21 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2018 to primary completion in Feb 2019, 11 months.
Results were first posted in Dec 2021, 2 years 9 months after primary completion.
Of 22 phase 2 interventional studies under Pancreatitis, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 110. This study's 11 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Zegocractin
CalciMedica, Inc.