A Phase 2 interventional study of CM4620-IE (Injectable Emulsion) and Placebo in Pneumonia, sponsored by CalciMedica, Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by CalciMedica, Inc. · Phase 2, Interventional, and Treatment
This is a single-blind study of Auxora in patients with critical COVID-19 pneumonia, consisting of up to 3 cohorts of escalating dose. The main goal was to assess pharmacodynamic parameters of immune response, while also assessing safety and tolerability of the drug in this patient population.
The primary objective of this study was to assess the pharmacodynamic response of bronchoalveolar lavage (BAL) T cell/monocyte subsets and chemokine release to various doses of Auxora in patients with critical COVID-19 pneumonia. Other objectives included assessment of safety and tolerability of Auxora in patients with critical COVID-19 pneumonia, as well as pharmacokinetic profile of Auxora in these patients. Efficacy was also to be examined based on all-cause mortality at day 60, number of days on mechanical ventilation after randomization, number of days in the hospital after randomization, and number of days in the ICU after randomization.
Patients were randomized 3:1 to Auxora or Placebo. The first 4 patients were enrolled in Cohort 1 (3 Auxora, 1 Placebo). If dose escalation occurred, the next 4 patients were to be enrolled in Cohort 2. If dose escalation occurred again, the next 8 patients were to be enrolled in Cohort 3. The decision to escalate dosing was made by CalciMedica in consultation with the PI and after the review of safety events in Cohorts 1 and 2.
(Note: Trial terminated early after the first patient was enrolled in Cohort 3 due to lack of new Covid-19 hospitalizations.)
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 10 is below the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 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.
Compared within COVID-19, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pneumonia. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Moderate ARDS characterized by the following criteria:
Exclusion Criteria:
The patient has a history of:
Current treatment with:
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.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
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.
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.
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.
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.
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.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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 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.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
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.
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.
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.
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.
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.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
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.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Auxora will be given as a continuous infusion: Day 1: All 3 cohorts will receive 1.25 mL/kg over 4 hours; After initial infusion is complete, Cohort 3 will receive a continuous infusion of 1.0 mL/kg/24 hours for 96 hours Day 2: Cohort 1 will receive 1.0 mL/kg over 4 hours; Cohort 2 will receive 1.25mL/kg over 4 hours Day 3: Cohort 1 and 2 will receive 1.0 mL/kg over 4 hours Day 4: Cohort 2 will receive 1.0 mL/kg over 4 hours
Drug: CM4620-IE (Injectable Emulsion)
Placebo will be given as a continuous infusion: Day 1: All 3 cohorts will receive 1.25 mL/kg over 4 hours. After initial infusion is complete, Cohort 3 will receive a continuous infusion of 1.0 mL/kg/24 hours for 96 hours Day 2: Cohort 1 will receive 1.0 mL/kg over 4 hours; Cohort 2 will receive 1.25mL/kg over 4 hours Day 3: Cohort 1 and 2 will receive 1.0 mL/kg over 4 hours Day 4: Cohort 2 will receive 1.0 mL/kg over 4 hours
Drug: Placebo
Auxora is an injectable emulsion containing 1.6mg/ML of the active pharmaceutical ingredient CM4620. Auxora will be administered intravenously as a continuous infusion
Also known as: Auxora
Matching placebo is an injectable emulsion containing no active pharmaceutical ingredient. Placebo will be administered intravenously as a continuous infusion
Change From Baseline in Combined CD4, CD8, and Monocyte Cell Population in BAL Fluid, as a Percent of Total WBC Population.
Pharmacodynamic endpoint: Assessment of pharmacodynamic response of bronchoalveolar lavage (BAL) T cell/monocyte subsets to Auxora treatment. Flow cytometry was performed on fluid collected from the BAL performed prior to the SFISD (-12 hours) and 24 (±12) hours after completing the last infusion of study drug in Cohorts 1 and 2 and during the final 24 hours of the continuous infusion in Cohort 3. The percentage of total WBC population was assessed for the combined CD4, CD8, and monocyte cell population, and the change between Pre- and Post-Infusion samples (Post value minus Pre value) was reported.
Time frame: Baseline Assessment up to 120 hours
Change From Baseline in Percent of Immune Cells in BAL Fluid
Pharmacodynamic endpoint: Assessment of pharmacodynamic response of bronchoalveolar lavage (BAL) T cell/monocyte subsets to Auxora treatment. Flow cytometry was performed on fluid collected from the BAL performed prior to the SFISD (-12 hours) and 24 (±12) hours after completing the last infusion of study drug in Cohorts 1 and 2 and during the final 24 hours of the continuous infusion in Cohort 3. The percentage of total WBC population was assessed for immune cell types and the change between Pre- and Post-Infusion samples (Post value minus Pre value) was reported.
Time frame: Baseline Assessment up to 120 hours
Number of Patients Alive at Day 60
Efficacy endpoint: All-cause Mortality at Day 60
Time frame: Randomization through Day 60
Number of Days Alive and Out of the Intensive Care Unit (ICU)
Efficacy Endpoint: Days in ICU (after randomization)
Time frame: From randomization until discharge from ICU, assessed up to 60 days
Number of Days Alive and Out of the Hospital
Efficacy endpoint: Days hospitalized (after randomization)
Time frame: From randomization until discharge from the hospital, assessed up to 60 days
Number of Days Alive and Off Mechanical Ventilation
Efficacy endpoint: Ventilator-free days (after randomization)
Time frame: From randomization until patient is extubated, assessed up to 60 days
Number of Patients Experiencing an AE Considered Possibly Related to Study Drug
Safety endpoint. Examines the relatedness of AEs to study drug by assessing the number of patients experiencing any AE (serious or non-serious) considered possibly related to Study Drug.
Time frame: Randomization through Day 30
Number of Patients Experiencing an SAE (at Least 1)
Safety Endpoint: Incidence of treatment emergent Serious Adverse Events (SAEs)
Time frame: Randomization through day 30
Intensity of AEs
Safety endpoint: Count of the number of AEs for each level of intensity: mild, moderate, or severe
Time frame: Randomization through Day 30
Number of Patients Experiencing Pre-defined Changes in Cardiac Conduction Assessed by ECG
Safety endpoint: Patients experiencing Changes in cardiac conduction, defined as: QTcF interval of ≥ 500 msec; QTcF prolongation of ≥ 60 msec as compared to baseline; Mobitz Type II second degree atrioventricular (AV) block; Third degree or high grade AV block; or Polymorphic Ventricular Tachycardia
Time frame: From randomization up to 144 hours after SFISD (start of first infusion of study drug)
| Milestone | Auxora Cohort 1 | Auxora Cohort 2 | Auxora Cohort 3 | Placebo |
|---|---|---|---|---|
| Started | 3 | 0 | 0 | 1 |
| Completed | 3 | 0 | 0 | 1 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | Auxora Cohort 1 | Auxora Cohort 2 | Auxora Cohort 3 | Placebo |
|---|---|---|---|---|
| Started | 0 | 3 | 0 | 1 |
| Completed | 0 | 3 | 0 | 1 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | Auxora Cohort 1 | Auxora Cohort 2 | Auxora Cohort 3 | Placebo |
|---|---|---|---|---|
| Started | 0 | 0 | 1 | 0 |
| Completed | 0 | 0 | 1 | 0 |
| Not completed | 0 | 0 | 0 | 0 |
Pharmacodynamic endpoint: Assessment of pharmacodynamic response of bronchoalveolar lavage (BAL) T cell/monocyte subsets to Auxora treatment. Flow cytometry was performed on fluid collected from the BAL performed prior to the SFISD (-12 hours) and 24 (±12) hours after completing the last infusion of study drug in Cohorts 1 and 2 and during the final 24 hours of the continuous infusion in Cohort 3. The percentage of total WBC population was assessed for the combined CD4, CD8, and monocyte cell population, and the change between Pre- and Post-Infusion samples (Post value minus Pre value) was reported.
| Percent of total WBC population | Auxora Cohort 1 | Auxora Cohort 2 | Auxora Cohort 3 | Placebo |
|---|---|---|---|---|
| Change From Baseline in Combined CD4, CD8, and Monocyte Cell Population in BAL Fluid, as a Percent of Total WBC Population. | -5.6 ± 31.6 | -7.2 ± 10.7 | 27.1 ± NA | 22.8 ± 9.7 |
Pharmacodynamic endpoint: Assessment of pharmacodynamic response of bronchoalveolar lavage (BAL) T cell/monocyte subsets to Auxora treatment. Flow cytometry was performed on fluid collected from the BAL performed prior to the SFISD (-12 hours) and 24 (±12) hours after completing the last infusion of study drug in Cohorts 1 and 2 and during the final 24 hours of the continuous infusion in Cohort 3. The percentage of total WBC population was assessed for immune cell types and the change between Pre- and Post-Infusion samples (Post value minus Pre value) was reported.
| Percent of total WBC population | Auxora Cohort 1 | Auxora Cohort 2 | Auxora Cohort 3 | Placebo |
|---|---|---|---|---|
| CD4 T Cells | -2.4 ± 15.7 | -3.4 ± 6.3 | 5.9 ± NA | 17.9 ± 5.4 |
| CD8 T Cells | -2.0 ± 12.5 | -0.5 ± 4.6 | 23.1 ± NA | 5.3 ± 3.9 |
| Neutrophils | -14.5 ± 43.9 | 24.4 ± 47.1 | -4.2 ± NA | -25.7 ± 24.0 |
| NK cells | -0.2 ± 1.5 | -1.8 ± 1.5 | 0.1 ± NA | 0.3 ± 1.3 |
| Monocytes | -1.2 ± 10.0 | -3.3 ± 5.8 | -13.4 ± NA | -0.4 ± 0.3 |
| B cells | 14.2 ± 10.4 | -12.4 ± 14.3 | 3.2 ± NA | -23.2 ± 29.9 |
| Macrophages | 6.3 ± 20.0 | -2.3 ± 23.1 | -3.8 ± NA | 25.2 ± 16.9 |
Efficacy endpoint: All-cause Mortality at Day 60
| Participants | Auxora (ALL) | Auxora Cohort 1 | Auxora Cohort 2 | Auxora Cohort 3 | Placebo |
|---|---|---|---|---|---|
| Number of Patients Alive at Day 60 | 3 | 1 | 1 | 1 | 1 |
Efficacy Endpoint: Days in ICU (after randomization)
| days | Auxora (ALL) | Auxora Cohort 1 | Auxora Cohort 2 | Auxora Cohort 3 | Placebo |
|---|---|---|---|---|---|
| Number of Days Alive and Out of the Intensive Care Unit (ICU) | 4.6 ± 8.0 | 6.3 ± 11.0 | 0 ± 0 | 13.0 ± NA | 0 ± 0 |
Efficacy endpoint: Days hospitalized (after randomization)
| days | Auxora (ALL) | Auxora Cohort 1 | Auxora Cohort 2 | Auxora Cohort 3 | Placebo |
|---|---|---|---|---|---|
| Number of Days Alive and Out of the Hospital | 1.0 ± 2.6 | 0 ± 0 | 0 ± 0 | 7.0 ± NA | 0 ± 0 |
Efficacy endpoint: Ventilator-free days (after randomization)
| days | Auxora (ALL) | Auxora Cohort 1 | Auxora Cohort 2 | Auxora Cohort 3 | Placebo |
|---|---|---|---|---|---|
| Number of Days Alive and Off Mechanical Ventilation | 5.9 ± 10.2 | 8.0 ± 13.9 | 0 ± 0 | 17.0 ± NA | 0 ± 0 |
Safety endpoint. Examines the relatedness of AEs to study drug by assessing the number of patients experiencing any AE (serious or non-serious) considered possibly related to Study Drug.
| Participants | Auxora (ALL) | Auxora Cohort 1 | Auxora Cohort 2 | Auxora Cohort 3 | Placebo |
|---|---|---|---|---|---|
| Possibly related SAEs | 0 | 0 | 0 | 0 | 0 |
| Possibly related non-serious AEs | 2 | 1 | 0 | 1 | 0 |
Safety Endpoint: Incidence of treatment emergent Serious Adverse Events (SAEs)
| Participants | Auxora (ALL) | Auxora Cohort 1 | Auxora Cohort 2 | Auxora Cohort 3 | Placebo |
|---|---|---|---|---|---|
| Number of Patients Experiencing an SAE (at Least 1) | 4 | 1 | 3 | 0 | 2 |
Safety endpoint: Count of the number of AEs for each level of intensity: mild, moderate, or severe
| Adverse Events | Auxora (ALL) | Auxora Cohort 1 | Auxora Cohort 2 | Auxora Cohort 3 | Placebo |
|---|---|---|---|---|---|
| Mild | 13 | 2 | 9 | 2 | 5 |
| Moderate | 21 | 11 | 8 | 2 | 7 |
| Severe | 8 | 2 | 6 | 0 | 2 |
Safety endpoint: Patients experiencing Changes in cardiac conduction, defined as: QTcF interval of ≥ 500 msec; QTcF prolongation of ≥ 60 msec as compared to baseline; Mobitz Type II second degree atrioventricular (AV) block; Third degree or high grade AV block; or Polymorphic Ventricular Tachycardia
| Participants | Auxora (ALL) | Auxora Cohort 1 | Auxora Cohort 2 | Auxora Cohort 3 | Placebo |
|---|---|---|---|---|---|
| Number of Patients Experiencing Pre-defined Changes in Cardiac Conduction Assessed by ECG | 0 | 0 | 0 | 0 | 0 |
Collected over Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Auxora (ALL) | 4/7 (57.1%) | 4/7 (57.1%) | 7/7 (100%) |
| Auxora Cohort 1 | 2/3 (66.7%) | 1/3 (33.3%) | 3/3 (100%) |
| Auxora Cohort 2 | 2/3 (66.7%) | 3/3 (100%) | 3/3 (100%) |
| Auxora Cohort 3 | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Placebo | 1/2 (50%) | 2/2 (100%) | 2/2 (100%) |
| Event | Auxora (ALL) | Auxora Cohort 1 | Auxora Cohort 2 | Auxora Cohort 3 | Placebo |
|---|---|---|---|---|---|
| AcidosisMetabolism and nutrition disorders | 0/7 | 0/3 | 0/3 | 0/1 | 1/2 |
| Respiratory FailureRespiratory, thoracic and mediastinal disorders | 0/7 | 0/3 | 0/3 | 0/1 | 1/2 |
| StridorRespiratory, thoracic and mediastinal disorders | 0/7 | 0/3 | 0/3 | 0/1 | 1/2 |
| Pulseless electrical activityCardiac disorders | 1/7 | 0/3 | 1/3 | 0/1 | 0/2 |
| Gastrointestinal hemorrhageGastrointestinal disorders | 1/7 | 0/3 | 1/3 | 0/1 | 0/2 |
| Acute Kidney InjuryRenal and urinary disorders | 1/7 | 0/3 | 1/3 | 0/1 | 0/2 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 2/7 | 1/3 | 1/3 | 0/1 | 0/2 |
| Septic shockVascular disorders | 1/7 | 0/3 | 1/3 | 0/1 | 0/2 |
| Distributive shockVascular disorders | 1/7 | 1/3 | 0/3 | 0/1 | 0/2 |
| Event | Auxora (ALL) | Auxora Cohort 1 | Auxora Cohort 2 | Auxora Cohort 3 | Placebo |
|---|---|---|---|---|---|
| HypertransaminasemiaHepatobiliary disorders | 4/7 | 2/3 | 1/3 | 1/1 | 1/2 |
| Blood creatine phosphokinase increasedInvestigations | 1/7 | 1/3 | 0/3 | 0/1 | 2/2 |
| HypertriglyceridemiaMetabolism and nutrition disorders | 1/7 | 0/3 | 0/3 | 1/1 | 0/2 |
| DeliriumPsychiatric disorders | 1/7 | 0/3 | 0/3 | 1/1 | 0/2 |
| Enterobacter pneumoniaRespiratory, thoracic and mediastinal disorders | 4/7 | 1/3 | 3/3 | 0/1 | 0/2 |
| Pneumonia staphylococcalRespiratory, thoracic and mediastinal disorders | 2/7 | 1/3 | 0/3 | 1/1 | 1/2 |
| PneumomediastinumRespiratory, thoracic and mediastinal disorders | 4/7 | 2/3 | 2/3 | 0/1 | 0/2 |
| Venous thrombosisVascular disorders | 3/7 | 1/3 | 2/3 | 0/1 | 1/2 |
| Enterococcal infectionInfections and infestations | 0/7 | 0/3 | 0/3 | 0/1 | 1/2 |
| Staphylococcal bacteremiaInfections and infestations | 0/7 | 0/3 | 0/3 | 0/1 | 1/2 |
Due to low enrollment trial was terminated early, and Auxora-treated patients from all Cohorts were combined into one arm for analysis. All placebo-treated patients were combined into one control arm as planned.
| Age, Continuous(years) | Auxora Cohort 1 | Auxora Cohort 2 | Auxora Cohort 3 | Placebo | Total |
|---|---|---|---|---|---|
| Mean | 53.0 ± 5.2 | 67.0 ± 3.0 | 46 ± NA | 54 ± 1.4 | 57 ± 8.4 |
| Sex: Female, Male(Participants) | Auxora Cohort 1 | Auxora Cohort 2 | Auxora Cohort 3 | Placebo | Total |
|---|---|---|---|---|---|
| Female | 1 | 1 | 0 | 1 | 3 |
| Male | 2 | 2 | 1 | 1 | 6 |
| Ethnicity (NIH/OMB)(Participants) | Auxora Cohort 1 | Auxora Cohort 2 | Auxora Cohort 3 | Placebo | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 2 | 3 | 1 | 0 | 6 |
| Not Hispanic or Latino | 1 | 0 | 0 | 2 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Auxora Cohort 1 | Auxora Cohort 2 | Auxora Cohort 3 | Placebo | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 1 | 1 |
| White | 1 | 2 | 0 | 1 | 4 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 1 | 1 | 0 | 4 |
| Region of Enrollment(participants) | Auxora Cohort 1 | Auxora Cohort 2 | Auxora Cohort 3 | Placebo | Total |
|---|---|---|---|---|---|
| United States | 3 | 3 | 1 | 2 | 9 |
| Height(cm) | Auxora Cohort 1 | Auxora Cohort 2 | Auxora Cohort 3 | Placebo | Total |
|---|---|---|---|---|---|
| Mean | 170.3 ± 16.6 | 164.7 ± 5.8 | 183 ± NA | 184.0 ± 12.7 | 172.9 ± 13.0 |
| Weight(kg) | Auxora Cohort 1 | Auxora Cohort 2 | Auxora Cohort 3 | Placebo | Total |
|---|---|---|---|---|---|
| Mean | 96.7 ± 26.5 | 78.0 ± 4.4 | 163.4 ± NA | 103.5 ± 26.2 | 99.4 ± 30.9 |
| BMI(kg/m^2) | Auxora Cohort 1 | Auxora Cohort 2 | Auxora Cohort 3 | Placebo | Total |
|---|---|---|---|---|---|
| Mean | 33.2 ± 6.6 | 28.9 ± 1.6 | 48.9 ± NA | 30.3 ± 3.6 | 32.9 ± 7.3 |
3 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2021 to primary completion in Dec 2021, 9 months.
Results were first posted in Nov 2025, 3 years 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Zegocractin
CalciMedica, Inc.