GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1Results posted

A Study to Understand How the Study Medicine (PF-07081532) is Processed in People With Liver Dysfunction

A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO COMPARE THE PHARMACOKINETICS OF PF-07081532 IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT HEPATIC IMPAIRMENT

Lead sponsor

Pfizer

Asset

Lotiglipron

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers, Hepatic impairment

Key I/E criterion

•BMI 17.5-38

Primary endpoints

•Cmax of PF-07081532•Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated•Area Under the Plasma Concentration-time Profile

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05478603

Org study IDC3991009

Timeline

Milestones

Study first posted2022-07-28actual

Study start2022-08-01actual

Primary completion2023-04-05actual

Study completion2023-04-05actual

Last update posted2024-08-22actual

Results first posted2024-08-22actual

Assets

Investigational agents

Lotiglipron

Study populations

Who this study enrolls

Healthy volunteersHepatic impairment

Eligibility

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Male or female between the ages of 18 and 70 years, inclusive at the screening visit.

•Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

•BMI of 17.5 to 38.0 kg/m2, inclusive, and a total body weight >50 kg (110 lb).

•Group 1 only: at screening, no clinically relevant abnormalities identified by a detailed medical history, physical exam, including blood pressure and pulse rate measurement, ECG and clinical laboratory tests.

•Group 1 only: no known or suspected hepatic impairment and meet the criteria based on screening laboratory liver function tests.

•Groups 2, 3 \& 4 only: stable hepatic impairment that meets criteria for Class A, B, or C of the Child-Pugh classification with no clinically significant change in disease status within 28 days before screening.

•Groups 2, 3 \& 4 only: stable concomitant medications for the management of individual participant's medical history.

Exclusion criteria

•Any condition possibly affecting drug absorption

•At screening, a positive result for HIV antibodies.

•Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2), or participants with suspected MTC per study doctor's judgement.

•History of acute pancreatitis within 6 months before the screening visit or any history of chronic pancreatitis.

•Other medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.

•Use of specific prohibited prior/concomitant therapies

•Use of an investigational product within 30 days (or local requirement) or 5 half-lives (whichever longer).

•eGFR<60 mL/min/1.73m2 at screening.

•A positive urine drug test at screening or admission to study clinic.

•At screening or admission to study clinic, a positive breath alcohol test.

•For females, pregnancy, as indicated by a positive serum pregnancy test at screening and/or positive urine pregnancy test in women capable of having children at admission to study clinic

•Group 1 only: evidence of chronic liver disease including history of hepatitis, hepatitis B, or hepatitis C.

•Group 1 only: history of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of screening.

•Group 1 only: screening ECG demonstrating QTcF interval >450 ms or a QRS interval >120 ms.

•Group 1 only: screening seated systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg

•Group 1 only: use of chronic prescription medications within 7 days or 5 half-lives (whichever longer) before Day 1, or for prohibited medications, use within the required washout/restriction period.

•Group 2, 3 \& 4 only: Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy (defined as <1 year in Groups 2 \& 3 and <6 months for Group 4 only).

•Group 2, 3 \& 4 only: a diagnosis of hepatic dysfunction secondary to any acute ongoing hepatocellular process that is documented by medical history, physical exam, liver biopsy, hepatic ultrasound, CT scan, or MRI.

•Group 2, 3 \& 4 only: history of surgery that would be expected to alter absorption, distribution, metabolism, or excretion properties of PF-07081532.

•Group 2, 3 \& 4 only: history of gastrointestinal hemorrhage due to esophageal varices or peptic ulcers less than 4 weeks prior to screening.

•Group 2, 3 \& 4 only: signs of clinically active Grade 3 or 4 hepatic encephalopathy

•Groups 2, 3 \& 4 only: severe ascites and/or pleural effusion, except for those categorized in Group 4 who may be enrolled provided participant is medically stable, per the study doctor's judgment.

•Groups 2, 3 \& 4 only: previously received a kidney, liver, or heart transplant.

•Groups 2, 3, \& 4 only: screening ECG demonstrating a QTcF interval >470 ms or a QRS interval >120 ms.

•Groups 2, 3 \& 4 only: at screening, admission to study clinic or pre-dose on Day 1, persistent severe, uncontrolled hypertension.

•Groups 2, 3 \& 4 only: ALT or AST >5x upper limit of normal on clinical laboratory tests at screening.

Endpoints (22)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

22 endpoints

Primary/registry result

Maximum Plasma Concentration (Cmax) of PF-07081532

Time frame:At 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on Day 1

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanogram per milliliter (ng/mL)	95% CI
Without Hepatic Impairment	2236	—
Mild Hepatic Impairment	2121	—
Moderate Hepatic Impairment	2230	—
Severe Hepatic Impairment	1536	—

Ratio of adjusted geometric means94.8890% CI70.86 – 127.04ANOVA

Ratio of adjusted geometric means99.7590% CI74.50 – 133.56ANOVA

Ratio of adjusted geometric means68.7090% CI51.31 – 91.98ANOVA

Primary/registry result

Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-07081532

Time frame:At 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on Day 1

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanogramhour per milliliter (nghr/mL)	95% CI
Without Hepatic Impairment	43200	—
Mild Hepatic Impairment	44010	—
Moderate Hepatic Impairment	67430	—
Severe Hepatic Impairment	41680	—

Ratio of adjusted geometric means101.8790% CI59.74 – 173.71ANOVA

Ratio of adjusted geometric means156.0790% CI91.53 – 266.14ANOVA

Ratio of adjusted geometric means96.4890% CI56.58 – 164.51ANOVA

Primary/registry result

Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-07081532

Time frame:At 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on Day 1

concentration, descriptive

Posted result

Group	Value (geometric_mean), ng*hr/mL	95% CI
Without Hepatic Impairment	40990	—
Mild Hepatic Impairment	41900	—
Moderate Hepatic Impairment	62680	—
Severe Hepatic Impairment	39800	—

Ratio of adjusted geometric means102.2190% CI59.91 – 174.39ANOVA

Ratio of adjusted geometric means152.9190% CI89.62 – 260.90ANOVA

Ratio of adjusted geometric means97.0890% CI56.90 – 165.65ANOVA

Primary/registry result

Fraction of Unbound Drug in Plasma (Fu) of PF-07081532

Time frame:At 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on Day 1

concentration, descriptive

Posted result

Group	Value (geometric_mean), Ratio	95% CI
Without Hepatic Impairment	0.0002753	—
Mild Hepatic Impairment	0.0002568	—
Moderate Hepatic Impairment	0.0002937	—
Severe Hepatic Impairment	0.0006780	—

Ratio of adjusted geometric means93.2990% CI64.61 – 134.69ANOVA

Ratio of adjusted geometric means106.6890% CI73.89 – 154.03ANOVA

Ratio of adjusted geometric means246.2890% CI170.57 – 355.58ANOVA

Primary/registry result

Unbound Cmax (Cmax,u) of PF-07081532

Time frame:At 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on Day 1

concentration, descriptive

Posted result

Group	Value (geometric_mean), ng/mL	95% CI
Without Hepatic Impairment	0.6156	—
Mild Hepatic Impairment	0.5448	—
Moderate Hepatic Impairment	0.6551	—
Severe Hepatic Impairment	1.042	—

Ratio of adjusted geometric means88.5090% CI64.13 – 122.12ANOVA

Ratio of adjusted geometric means106.4090% CI77.11 – 146.83ANOVA

Ratio of adjusted geometric means169.1990% CI122.61 – 233.47ANOVA

Primary/registry result

Unbound AUCinf (AUCinf,u) of PF-07081532

Time frame:At 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on Day 1

descriptive

Posted result

Group	Value (geometric_mean), ng*hr/mL	95% CI
Without Hepatic Impairment	11.88	—
Mild Hepatic Impairment	11.30	—
Moderate Hepatic Impairment	19.81	—
Severe Hepatic Impairment	28.24	—

Ratio of adjusted geometric means95.1290% CI52.60 – 172.03ANOVA

Ratio of adjusted geometric means166.7790% CI92.21 – 301.62ANOVA

Ratio of adjusted geometric means237.7690% CI131.46 – 430.00ANOVA

Primary/registry result

Unbound AUClast (AUClast,u) of PF-07081532

Time frame:At 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on Day 1

descriptive

Posted result

Group	Value (geometric_mean), ng*hr/mL	95% CI
Without Hepatic Impairment	11.29	—
Mild Hepatic Impairment	10.76	—
Moderate Hepatic Impairment	18.41	—
Severe Hepatic Impairment	27.02	—

Ratio of adjusted geometric means95.3490% CI52.67 – 172.59ANOVA

Ratio of adjusted geometric means163.0990% CI90.10 – 295.22ANOVA

Ratio of adjusted geometric means239.4790% CI132.29 – 433.47ANOVA

Primary/protocol endpoint

Maximum Plasma Concentration (Cmax) of PF-07081532

Time frame:At 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on Day 1

Cmax

concentration, descriptive

Primary/protocol endpoint

Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-07081532

Time frame:At 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on Day 1

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-07081532

Time frame:At 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on Day 1

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Fraction of Unbound Drug in Plasma (Fu) of PF-07081532

Time frame:At 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on Day 1

ratio, descriptive

Primary/protocol endpoint

Unbound Cmax (Cmax,u) of PF-07081532

Time frame:At 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on Day 1

Cmax

concentration, descriptive

Primary/protocol endpoint

Unbound AUCinf (AUCinf,u) of PF-07081532

Time frame:At 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on Day 1

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Unbound AUClast (AUClast,u) of PF-07081532

Time frame:At 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on Day 1

AUC₀–∞

concentration, descriptive

Secondary/registry result

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Time frame:Day 1 to Day 36

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Without Hepatic ImpairmentAll-causality TEAEs	1	—
Treatment-related TEAEs	0	—
Mild Hepatic ImpairmentAll-causality TEAEs	0	—
Treatment-related TEAEs	0	—
Moderate Hepatic ImpairmentAll-causality TEAEs	0	—
Treatment-related TEAEs	0	—
Severe Hepatic ImpairmentAll-causality TEAEs	1	—
Treatment-related TEAEs	1	—

Secondary/registry result

Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)

Time frame:From baseline (BL) to Day 7

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Without Hepatic ImpairmentHemoglobin (gram per deciliter [g/dL]) <0.8*lower limit of normal (LLN)	0	—
Hematocrit (%) <0.8*LLN	0	—
Erythrocytes (10^12/liter [L]) <0.8*LLN	0	—
Ery. Mean Corpuscular Volume (femtoliter [fL]) >1.1*ULN	0	—
Ery. Mean Corpuscular Hemoglobin (picogram/cell [pg/cell]) <0.9*LLN	1	—
Platelets (10^9/L) <0.5*LLN	0	—
Neutrophils (10^9/L) <0.8*LLN	0	—
Basophils/Leukocytes (%) >1.2*ULN	0	—
Eosinophils/Leukocytes (%) >1.2*ULN	0	—
Monocytes/Leukocytes (%) >1.2*ULN	0	—
Activated Partial Thromboplastin Time (second [sec]) >1.1*ULN	2	—
Prothrombin Time (sec) >1.1*ULN	0	—
Prothrombin International Normalized Ratio >1.1*ULN	0	—
Bilirubin (milligram per deciliter [mg/dL]) >1.5*ULN	0	—
Direct Bilirubin (mg/dL) >1.5*ULN	0	—
Indirect Bilirubin (mg/dL) >1.5*ULN	0	—
Aspartate Aminotransferase (unit per liter [U/L]) >3.0*ULN	0	—
Gamma Glutamyl Transferase (U/L) >3.0*ULN	0	—
Albumin (g/dL) <0.8*LLN	0	—
Urate (mg/dL) >1.2*ULN	0	—
Ketones ≥1	0	—
URINE Hemoglobin ≥1	0	—
Urobilinogen ≥1	0	—
URINE Bilirubin ≥1	0	—
Leukocyte Esterase ≥1	1	—
Epithelial Cells (/low-power field [LPF]) ≥6	0	—
Mild Hepatic ImpairmentHemoglobin (gram per deciliter [g/dL]) <0.8*lower limit of normal (LLN)	0	—
Hematocrit (%) <0.8*LLN	0	—
Erythrocytes (10^12/liter [L]) <0.8*LLN	0	—
Ery. Mean Corpuscular Volume (femtoliter [fL]) >1.1*ULN	0	—
Ery. Mean Corpuscular Hemoglobin (picogram/cell [pg/cell]) <0.9*LLN	0	—
Platelets (10^9/L) <0.5*LLN	0	—
Neutrophils (10^9/L) <0.8*LLN	0	—
Basophils/Leukocytes (%) >1.2*ULN	0	—
Eosinophils/Leukocytes (%) >1.2*ULN	0	—
Monocytes/Leukocytes (%) >1.2*ULN	0	—
Activated Partial Thromboplastin Time (second [sec]) >1.1*ULN	5	—
Prothrombin Time (sec) >1.1*ULN	1	—
Prothrombin International Normalized Ratio >1.1*ULN	1	—
Bilirubin (milligram per deciliter [mg/dL]) >1.5*ULN	0	—
Direct Bilirubin (mg/dL) >1.5*ULN	0	—
Indirect Bilirubin (mg/dL) >1.5*ULN	0	—
Aspartate Aminotransferase (unit per liter [U/L]) >3.0*ULN	1	—
Gamma Glutamyl Transferase (U/L) >3.0*ULN	1	—
Albumin (g/dL) <0.8*LLN	0	—
Urate (mg/dL) >1.2*ULN	0	—
Ketones ≥1	0	—
URINE Hemoglobin ≥1	0	—
Urobilinogen ≥1	0	—
URINE Bilirubin ≥1	0	—
Leukocyte Esterase ≥1	2	—
Epithelial Cells (/low-power field [LPF]) ≥6	0	—
Moderate Hepatic ImpairmentHemoglobin (gram per deciliter [g/dL]) <0.8*lower limit of normal (LLN)	0	—
Hematocrit (%) <0.8*LLN	0	—
Erythrocytes (10^12/liter [L]) <0.8*LLN	0	—
Ery. Mean Corpuscular Volume (femtoliter [fL]) >1.1*ULN	1	—
Ery. Mean Corpuscular Hemoglobin (picogram/cell [pg/cell]) <0.9*LLN	0	—
Platelets (10^9/L) <0.5*LLN	1	—
Neutrophils (10^9/L) <0.8*LLN	0	—
Basophils/Leukocytes (%) >1.2*ULN	1	—
Eosinophils/Leukocytes (%) >1.2*ULN	0	—
Monocytes/Leukocytes (%) >1.2*ULN	0	—
Activated Partial Thromboplastin Time (second [sec]) >1.1*ULN	5	—
Prothrombin Time (sec) >1.1*ULN	2	—
Prothrombin International Normalized Ratio >1.1*ULN	3	—
Bilirubin (milligram per deciliter [mg/dL]) >1.5*ULN	2	—
Direct Bilirubin (mg/dL) >1.5*ULN	2	—
Indirect Bilirubin (mg/dL) >1.5*ULN	1	—
Aspartate Aminotransferase (unit per liter [U/L]) >3.0*ULN	0	—
Gamma Glutamyl Transferase (U/L) >3.0*ULN	2	—
Albumin (g/dL) <0.8*LLN	0	—
Urate (mg/dL) >1.2*ULN	1	—
Ketones ≥1	0	—
URINE Hemoglobin ≥1	0	—
Urobilinogen ≥1	1	—
URINE Bilirubin ≥1	0	—
Leukocyte Esterase ≥1	1	—
Epithelial Cells (/low-power field [LPF]) ≥6	1	—
Severe Hepatic ImpairmentHemoglobin (gram per deciliter [g/dL]) <0.8*lower limit of normal (LLN)	3	—
Hematocrit (%) <0.8*LLN	2	—
Erythrocytes (10^12/liter [L]) <0.8*LLN	1	—
Ery. Mean Corpuscular Volume (femtoliter [fL]) >1.1*ULN	0	—
Ery. Mean Corpuscular Hemoglobin (picogram/cell [pg/cell]) <0.9*LLN	1	—
Platelets (10^9/L) <0.5*LLN	1	—
Neutrophils (10^9/L) <0.8*LLN	1	—
Basophils/Leukocytes (%) >1.2*ULN	1	—
Eosinophils/Leukocytes (%) >1.2*ULN	2	—
Monocytes/Leukocytes (%) >1.2*ULN	3	—
Activated Partial Thromboplastin Time (second [sec]) >1.1*ULN	5	—
Prothrombin Time (sec) >1.1*ULN	6	—
Prothrombin International Normalized Ratio >1.1*ULN	6	—
Bilirubin (milligram per deciliter [mg/dL]) >1.5*ULN	4	—
Direct Bilirubin (mg/dL) >1.5*ULN	4	—
Indirect Bilirubin (mg/dL) >1.5*ULN	3	—
Aspartate Aminotransferase (unit per liter [U/L]) >3.0*ULN	1	—
Gamma Glutamyl Transferase (U/L) >3.0*ULN	1	—
Albumin (g/dL) <0.8*LLN	4	—
Urate (mg/dL) >1.2*ULN	0	—
Ketones ≥1	2	—
URINE Hemoglobin ≥1	1	—
Urobilinogen ≥1	3	—
URINE Bilirubin ≥1	1	—
Leukocyte Esterase ≥1	1	—
Epithelial Cells (/low-power field [LPF]) ≥6	1	—

Secondary/registry result

Number of Participants With Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria

Time frame:From BL to Day 7

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Without Hepatic ImpairmentDiastolic BP Value <50mmHg	0	—
Diastolic BP Increase ≥20mmHg	1	—
Diastolic BP Decrease ≥20mmHg	0	—
Pulse Rate Value <40bpm	0	—
Pulse Rate Value >120bpm	0	—
Systolic BP Value <90mmHg	0	—
Systolic BP Increase ≥30mmHg	0	—
Systolic BP Decrease ≥30mmHg	0	—
Mild Hepatic ImpairmentDiastolic BP Value <50mmHg	0	—
Diastolic BP Increase ≥20mmHg	0	—
Diastolic BP Decrease ≥20mmHg	0	—
Pulse Rate Value <40bpm	0	—
Pulse Rate Value >120bpm	0	—
Systolic BP Value <90mmHg	0	—
Systolic BP Increase ≥30mmHg	0	—
Systolic BP Decrease ≥30mmHg	0	—
Moderate Hepatic ImpairmentDiastolic BP Value <50mmHg	1	—
Diastolic BP Increase ≥20mmHg	0	—
Diastolic BP Decrease ≥20mmHg	1	—
Pulse Rate Value <40bpm	0	—
Pulse Rate Value >120bpm	0	—
Systolic BP Value <90mmHg	0	—
Systolic BP Increase ≥30mmHg	0	—
Systolic BP Decrease ≥30mmHg	2	—
Severe Hepatic ImpairmentDiastolic BP Value <50mmHg	0	—
Diastolic BP Increase ≥20mmHg	1	—
Diastolic BP Decrease ≥20mmHg	0	—
Pulse Rate Value <40bpm	0	—
Pulse Rate Value >120bpm	0	—
Systolic BP Value <90mmHg	0	—
Systolic BP Increase ≥30mmHg	0	—
Systolic BP Decrease ≥30mmHg	0	—

Secondary/registry result

Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria

Time frame:From BL to Day 7

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Without Hepatic ImpairmentPR Interval Value ≥ 300 msec	0	—
PR Interval %Change ≥ 25/50% msec	0	—
QRS Interval Value ≥ 140 msec	0	—
QRS Interval %Change ≥ 50% msec	0	—
QTcF 450 < Value ≤ 480 msec	0	—
QTcF 480 < Value ≤ 500 msec	0	—
QTcF Value > 500 msec	0	—
QTcF 30 < Change ≤ 60 msec	0	—
QTcF Change > 60 msec	0	—
Mild Hepatic ImpairmentPR Interval Value ≥ 300 msec	0	—
PR Interval %Change ≥ 25/50% msec	0	—
QRS Interval Value ≥ 140 msec	0	—
QRS Interval %Change ≥ 50% msec	0	—
QTcF 450 < Value ≤ 480 msec	0	—
QTcF 480 < Value ≤ 500 msec	0	—
QTcF Value > 500 msec	0	—
QTcF 30 < Change ≤ 60 msec	0	—
QTcF Change > 60 msec	0	—
Moderate Hepatic ImpairmentPR Interval Value ≥ 300 msec	0	—
PR Interval %Change ≥ 25/50% msec	0	—
QRS Interval Value ≥ 140 msec	0	—
QRS Interval %Change ≥ 50% msec	0	—
QTcF 450 < Value ≤ 480 msec	0	—
QTcF 480 < Value ≤ 500 msec	0	—
QTcF Value > 500 msec	0	—
QTcF 30 < Change ≤ 60 msec	0	—
QTcF Change > 60 msec	0	—
Severe Hepatic ImpairmentPR Interval Value ≥ 300 msec	0	—
PR Interval %Change ≥ 25/50% msec	0	—
QRS Interval Value ≥ 140 msec	0	—
QRS Interval %Change ≥ 50% msec	0	—
QTcF 450 < Value ≤ 480 msec	3	—
QTcF 480 < Value ≤ 500 msec	0	—
QTcF Value > 500 msec	0	—
QTcF 30 < Change ≤ 60 msec	0	—
QTcF Change > 60 msec	0	—

Secondary/protocol endpoint

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Time frame:Day 1 to Day 36

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)

Time frame:From baseline (BL) to Day 7

event count, event

Secondary/protocol endpoint

Number of Participants With Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria

Time frame:From BL to Day 7

threshold achievement, event

componentsDiastolic BP, change, Systolic BP, change, Heart rate, change

Secondary/protocol endpoint

Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria

Time frame:From BL to Day 7

threshold achievement, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.