Liver DiseasesPhase 1NCT05857644

A Study to Compare How the Study Medicine (PF-07923568) is Processed in Participants With Different Levels of Loss of Liver Function to Healthy Participants.

A Phase 1 study testing PF-07923568 in people with Liver Diseases and Hepatic Impairment, run by Pfizer at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to learn how the study medicine (PF-07923568) is processed in participants with liver function loss compared to healthy participants. The different levels of liver function loss can be mild, moderate or severe. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Liver Diseases, Hepatic Impairment
What is being tested?: PF-07923568
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 3 sitesUnited States
Study dates: 7 Jun 2023to 7 Feb 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

BMI of 17.5 to 38.0 kg/m2, inclusive, and a total body weight >50 kg (110 lb).
Capable of giving signed informed consent.
At screening, no clinically relevant abnormalities identified by a detailed medical history, complete physical examination, including BP and pulse rate measurement, standard 12-lead ECG and clinical laboratory tests.
body weight within +/-15 kg of the average of pooled hepatic impaired group and +/- 10 years of the average pooled hepatic impairment group.
--Exclusion criteria for all participants:
Any condition or surgery possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection)

Show all 15Show fewer

Positive HIV antibodies
Positive drug or alcohol test eGFR <60 mL/min/1.73m2 at screening
Exclusion criteria for non-healthy participants who have hepatic impairment:
Stable concomitant meds and hepatic impairment with no change in the last 28 days
Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy (defined as <1 year).
A diagnosis of hepatic dysfunction secondary to any acute ongoing hepatocellular process that is documented by medical history, PE, liver biopsy, hepatic ultrasound, CT scan, or MRI.
History of gastrointestinal hemorrhage due to esophageal varices or peptic ulcers less than 4 weeks prior to screening.
--Severe ascites and/or pleural effusion, except for those categorized as severe hepatic impairment who may be enrolled provided participant is medically stable, per the investigators' medical judgment.
Previously received a kidney, liver, or heart transplant. ALT/AST greater than 5X upper limit normal

Who cannot join

None listed.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Orlando Clinical Research Center
Orlando, Florida, 32809
Genesis Clinical Research, LLC
Tampa, Florida, 33603
Orange County Research Center
Tustin, California, 92780

Other trials in United States

About this study

Official title: A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO COMPARE THE PHARMACOKINETICS OF PF-07923568 IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT HEPATIC IMPAIRMENT

This study is seeking participants who:

are male or female of 18 years of age or older.
are examined to be healthy (group with no loss of liver function).
have mild, moderate, and severe liver disease (group with loss of liver function).

All participants will receive a one-time dose of 4 capsules of PF-07923568 which will be taken by mouth. All participants will remain at the study clinic for 6 days for safety review and laboratory collections. This is to see how the study medicine is being broken down by the liver over time.

All participants selected in the study will be required to go through a screening period up to 28 days. A screening period is the time during which a few participants are examined to see whether they are fit for the study. During this period, the participant's medical history and past and current medications will be reviewed. A series of tests will also be performed to see if they are good to be selected for the study. If the participant meets all required criteria and are interested in continuing, the participant will be brought into the study clinic to stay overnight for 6 days. On day 6, the participant will be discharged. About 28 to 35 days after discharge, the participant will be contacted for a follow up visit either in person or by telephone. This is to check up on how the participant is doing and to conclude the study.

Conditions: Liver Diseases, Hepatic Impairment
Being tested: PF-07923568
Keywords: healthy volunteers
Medical subject headings: Liver Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PF-07923568Drug
Also called Sisunatovir
One time dose of 4 capsules taken orally.

Study groups in NCT05857644
Study group	Role	What they receive
Healthy subjects	Experimental	One time dose of 4 capsules taken orally. Receives: Drug: PF-07923568
Mild Hepatic impaired subjects	Experimental	One time dose of 4 capsules taken orally. Receives: Drug: PF-07923568
Moderate hepatic impaired subjects	Experimental	One time dose of 4 capsules taken orally Receives: Drug: PF-07923568
Severe Hepatic Impaired Subjects	Experimental	One time dose of 4 capsules taken orally. Receives: Drug: PF-07923568

What is being measured

The primary outcome is the main question the study is designed to answer.

Plasma Maximum Concentration (Cmax) of Sisunatovir Following Administration of a Single Oral Dose
Cmax was the highest concentration observed directly from data
Measured: Hours 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, and 120 postdose from Day 1 to Day 6
Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sisunatovir Following Administration of a Single Oral Dose
AUClast was determined using linear/Log trapezoidal method
Measured: Hours 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, and 120 postdose from Day 1 to Day 6
Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Sisunatovir Following Administration of a Single Oral Dose
AUClast + (Clast*/kel), where Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the terminalphase rate constant.
Measured: Hours 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, and 120 postdose from Day 1 to Day 6

Secondary outcomes (4)

Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs
Adverse event (AE) was any untoward medical occurrence in the participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Serious AE was any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or was considered to be an important medical event. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent. AEs included both serious and non-serious AEs.
Measured: Day -1 through follow-up (Day 29-36)
Number of Participants With Laboratory Test Abnormalities
Laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, absolute and percent total neutrophils, eosinophils, monocytes, basophils and lymphocytes), chemistry (blood urea nitrogen/urea and creatinine, fasting glucose, calcium, sodium, potassium, chloride, total carbon dioxide, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin and total protein), urinalysis (pH, qualitative glucose, qualitative protein, qualitative blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy, urinary albumin to creatinine ratio and urinary protein to creatinine ratio) and other tests. Abnormality was determined by the investigator. Only lab abnormalities with at least 1 occurrence in participants are reported.
Measured: Day -1 and Day 6
Number of Participants With Vital Signs Meeting Categorical Criteria
Supine blood pressure and pulse rate were measured. Categorical classes for vital signs of potential clinical concerns were defined as followed: systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); diastolic blood pressure (DBP) <50 mmHg; pulse rate <40 beats per minute (bpm); pulse rate >120 bpm, and increase from baseline in SBP ≥30 mmHg; decrease from baseline in SBP ≥30 mmHg; increase from baseline in DBP ≥20 mmHg; decrease from baseline in DBP ≥20 mmHg. The baseline measurement was the predose measurement on Day 1. Changes from baseline was defined as the change between the postdose and baseline measurements.
Measured: Day -1, Day 1, Day 2, and Day 6
Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria
Number of participants with ECG findings meeting the following criteria: time between the onset of atrial depolarization and onset of ventricular depolarization (PR interval) ≥300 msec; time from ECG Q-wave to the end of the S wave corresponding to ventricular depolarization (QRS duration) ≥140 msec; correct time from ECG Q-wave to the end of the T wave corresponding to electrical systole for heart rate using Fridericia's formula (QTcF interval): ≥450 to <480 msec; QTcF interval ≥480 to <500 msec; QTcF interval: ≥500 msec; PR interval percent change from baseline (≥25/50%): ≥25% if baseline >200 msec or ≥ 50% if baseline ≤200 msec; QRS duration percent change from baseline ≥50%; QTcF interval change from baseline: >30 to ≤60 msec; QTcF interval change from baseline >60 msec. The baseline measurement was the predose measurement on Day 1. Changes from baseline was defined as the change between the postdose and baseline measurements.
Measured: Day -1, Day 1, Day 2, and Day 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jun 20237 Feb 2024

First posted12 May 2023
Study start7 Jun 2023
Primary completion7 Feb 2024
Study completion7 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Liver DiseasesStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: An open-label, single dose, parallel group, multicenter study to investigate the effect of varying degrees of hepatic function on the plasma PK of PF-07923568 after a single, oral 200 mg dose administered in the fed state (standard breakfast).
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05857644
Sponsor's protocol ID: C5241012
Other IDs: NCT05857644
Status last verified: Mar 2025
First submitted: 6 Apr 2023
Last updated: 21 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO COMPARE THE PHARMACOKINETICS OF PF-07923568 IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT HEPATIC IMPAIRMENT
ClinicalTrials.gov ID: NCT05857644
Acronym / sponsor ID: C5241012
Conditions: Liver Diseases, Hepatic Impairment
Keywords: healthy volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 7 Jun 2023 (actual)
Primary completion: 7 Feb 2024 (actual)
Study completion: 7 Feb 2024 (actual)
First posted: 12 May 2023 (actual)
Results: Posted 21 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is seeking participants who:

are male or female of 18 years of age or older.
are examined to be healthy (group with no loss of liver function).
have mild, moderate, and severe liver disease (group with loss of liver function).

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4
Model description: An open-label, single dose, parallel group, multicenter study to investigate the effect of varying degrees of hepatic function on the plasma PK of PF-07923568 after a single, oral 200 mg dose administered in the fed state (standard breakfast).

Arm	Type	Receives
Healthy subjects	Experimental	Drug: PF-07923568One time dose of 4 capsules taken orally.
Mild Hepatic impaired subjects	Experimental	Drug: PF-07923568One time dose of 4 capsules taken orally.
Moderate hepatic impaired subjects	Experimental	Drug: PF-07923568One time dose of 4 capsules taken orally
Severe Hepatic Impaired Subjects	Experimental	Drug: PF-07923568One time dose of 4 capsules taken orally.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

BMI of 17.5 to 38.0 kg/m2, inclusive, and a total body weight >50 kg (110 lb).
Capable of giving signed informed consent.
At screening, no clinically relevant abnormalities identified by a detailed medical history, complete physical examination, including BP and pulse rate measurement, standard 12-lead ECG and clinical laboratory tests.
body weight within +/-15 kg of the average of pooled hepatic impaired group and +/- 10 years of the average pooled hepatic impairment group.
Any condition or surgery possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection)

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PF-07923568Also: SisunatovirOne time dose of 4 capsules taken orally.	Drug	Healthy subjects, Mild Hepatic impaired subjects, Moderate hepatic impaired subjects, Severe Hepatic Impaired Subjects

Primary outcome

Plasma Maximum Concentration (Cmax) of Sisunatovir Following Administration of a Single Oral Dose
Time frame: Hours 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, and 120 postdose from Day 1 to Day 6
Cmax was the highest concentration observed directly from data
Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sisunatovir Following Administration of a Single Oral Dose
Time frame: Hours 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, and 120 postdose from Day 1 to Day 6
AUClast was determined using linear/Log trapezoidal method
Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Sisunatovir Following Administration of a Single Oral Dose
Time frame: Hours 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, and 120 postdose from Day 1 to Day 6
AUClast + (Clast*/kel), where Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the terminalphase rate constant.

4 secondary outcomes

Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs
Time frame: Day -1 through follow-up (Day 29-36)
Number of Participants With Laboratory Test Abnormalities
Time frame: Day -1 and Day 6
Number of Participants With Vital Signs Meeting Categorical Criteria
Time frame: Day -1, Day 1, Day 2, and Day 6
Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria
Time frame: Day -1, Day 1, Day 2, and Day 6

Results and safety

Results posted to the registry on 21 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
No Hepatic Impairment	8	8
Mild Hepatic Impairment	8	8
Moderate Hepatic Impairment	8	8
Severe Hepatic Impairment	4	4

Primary outcome: Plasma Maximum Concentration (Cmax) of Sisunatovir Following Administration of a Single Oral Dose

Time frame: Hours 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, and 120 postdose from Day 1 to Day 6. Geometric mean (Geometric Coefficient of Variation). Unit: Nanograms/milliliter (ng/mL)

Measure	No Hepatic Impairment n = 8	Mild Hepatic Impairment n = 8	Moderate Hepatic Impairment n = 8	Severe Hepatic Impairment n = 4
Value	81.25 (57)	68.52 (73)	73.85 (73)	127.8 (38)

No Hepatic Impairment vs Mild Hepatic Impairment: Geometric mean ratio: 84.33 (90% CI 50.94 to 139.59)
No Hepatic Impairment vs Moderate Hepatic Impairment: Geometric mean ratio: 90.89 (90% CI 54.91 to 150.45)
No Hepatic Impairment vs Severe Hepatic Impairment: Geometric mean ratio: 157.23 (90% CI 84.81 to 291.49)

Population analysed: All participants who received at least 1 dose of sisunatovir and had at least 1 of the pharmacokenetic parameters of interest calculated.

Primary outcome: Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sisunatovir Following Administration of a Single Oral Dose

Time frame: Hours 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, and 120 postdose from Day 1 to Day 6. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms*hour/milliliter (ng*hr/mL)

Measure	No Hepatic Impairment n = 8	Mild Hepatic Impairment n = 8	Moderate Hepatic Impairment n = 8	Severe Hepatic Impairment n = 4
Value	891.6 (37)	732.6 (70)	1166 (99)	3437 (20)

No Hepatic Impairment vs Mild Hepatic Impairment: Geometric mean ratio: 82.17 (90% CI 49.24 to 137.11)
No Hepatic Impairment vs Moderate Hepatic Impairment: Geometric mean ratio: 130.82 (90% CI 78.40 to 218.30)
No Hepatic Impairment vs Severe Hepatic Impairment: Geometric mean ratio: 385.52 (90% CI 205.92 to 721.77)

Population analysed: All participants who received at least 1 dose of sisunatovir and had at least 1 of the pharmacokenetic parameters of interest calculated.

Primary outcome: Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Sisunatovir Following Administration of a Single Oral Dose

Time frame: Hours 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, and 120 postdose from Day 1 to Day 6. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	No Hepatic Impairment n = 8	Mild Hepatic Impairment n = 8	Moderate Hepatic Impairment n = 8	Severe Hepatic Impairment n = 4
Value	922.6 (35)	765.6 (68)	1213 (95)	3617 (19)

No Hepatic Impairment vs Mild Hepatic Impairment: Geometric mean ratio: 82.99 (90% CI 50.53 to 136.28)
No Hepatic Impairment vs Moderate Hepatic Impairment: Geometric mean ratio: 131.52 (90% CI 80.09 to 215.99)
No Hepatic Impairment vs Severe Hepatic Impairment: Geometric mean ratio: 392.10 (90% CI 213.57 to 719.85)

Population analysed: All participants who received at least 1 dose of sisunatovir and had at least 1 of the pharmacokenetic parameters of interest calculated.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day -1 through follow-up (Day 29-36). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
No Hepatic Impairment	0 of 8 (0%)	1 of 8 (12.5%)	0 of 8
Mild Hepatic Impairment	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Moderate Hepatic Impairment	0 of 8 (0%)	1 of 8 (12.5%)	0 of 8
Severe Hepatic Impairment	0 of 4 (0%)	1 of 4 (25%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-07923568 in people with Liver Diseases and Hepatic Impairment, run by Pfizer at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma Maximum Concentration (Cmax) of Sisunatovir Following Administration of a Single Oral Dose (time frame: Hours 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, and 120 postdose from Day 1 to Day 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05857644.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025; AzTrials last refreshed its copy on 26 Oct 2026.