Trial Outcomes & Findings for GT-032 Belapectin Hepatic Impairment (NCT NCT04332432)
NCT ID: NCT04332432
Last Updated: 2026-07-14
Results Overview
Statistical comparison of the pharmacokinetic AUC0-∞ parameters of belapectin in plasma from varying degrees of hepatic impairment to normal hepatic function following a single intravenous dose . AUC0-∞ = area under the concentration-time curve from time 0 to infinity.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
38 participants
Primary outcome timeframe
Blood PK: Day -1 to 336 hours post dose
Results posted on
2026-07-14
Participant Flow
Subjects were enrolled into the following groups based on their hepatic function, as determined according to the Child-Pugh system. 38 subjects were dosed and completed the study in accordance with the protocol. All 38 subjects completed the study. There was only 1 treatment assignment for this trial, stratified by disease severity. Subjects were administered a single dose of belapectin (4 mg/kg LBM) intravenously on Day 1. The study was open label.
Participant milestones
| Measure |
Group 1
14 matched healthy subjects with normal hepatic function. Healthy subjects with normal hepatic function (Group 1) were demographically matched by age (±10 years), sex, and body mass index (BMI ±20%) to subjects with hepatic impairment (Groups 2, 3, and 4). Subjects were administered a single dose of belapectin (4 mg/kg LBM) intravenously on Day 1.
|
Group 2
8 subjects with mild hepatic impairment (Child-Pugh Class A \[4 x subjects with a score of 5 and 4 x subjects with a score of 6\]). Subjects were administered a single dose of belapectin (4 mg/kg LBM) intravenously on Day 1.
|
Group 3
8 subjects with moderate hepatic impairment (Child-Pugh Class B \[score of 7 to 9\]). Subjects were administered a single dose of belapectin (4 mg/kg LBM) intravenously on Day 1.
|
Group 4
8 subjects with severe hepatic impairment (Child-Pugh Class C \[score of 10 to 14\]). Subjects were administered a single dose of belapectin (4 mg/kg LBM) intravenously on Day 1.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
14
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
GT-032 Belapectin Hepatic Impairment
Baseline characteristics by cohort
| Measure |
Group 1
n=14 Participants
Normal hepatic function
|
Group 2
n=8 Participants
Mild hepatic impairment
|
Group 3
n=8 Participants
Moderate hepatic impairment
|
Group 4
n=8 Participants
Severe hepatic impairment
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Region of Enrollment
United States
|
14 participants
n=9 Participants
|
8 participants
n=27 Participants
|
8 participants
n=267 Participants
|
8 participants
n=265 Participants
|
38 participants
n=568 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Age, Continuous
|
54.7 years
STANDARD_DEVIATION 8.92 • n=9 Participants
|
60.3 years
STANDARD_DEVIATION 6.04 • n=27 Participants
|
61.4 years
STANDARD_DEVIATION 9.58 • n=267 Participants
|
49.9 years
STANDARD_DEVIATION 10.29 • n=265 Participants
|
56.3 years
STANDARD_DEVIATION 9.54 • n=568 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
3 Participants
n=265 Participants
|
20 Participants
n=568 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
5 Participants
n=265 Participants
|
18 Participants
n=568 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
2 Participants
n=568 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
8 Participants
n=267 Participants
|
8 Participants
n=265 Participants
|
36 Participants
n=568 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
BMI
|
30.98 kg/m2
STANDARD_DEVIATION 4.836 • n=9 Participants
|
32.7 kg/m2
STANDARD_DEVIATION 7.050 • n=27 Participants
|
31.44 kg/m2
STANDARD_DEVIATION 5.367 • n=267 Participants
|
33.23 kg/m2
STANDARD_DEVIATION 8.337 • n=265 Participants
|
31.91 kg/m2
STANDARD_DEVIATION 6.091 • n=568 Participants
|
PRIMARY outcome
Timeframe: Blood PK: Day -1 to 336 hours post doseStatistical comparison of the pharmacokinetic AUC0-∞ parameters of belapectin in plasma from varying degrees of hepatic impairment to normal hepatic function following a single intravenous dose . AUC0-∞ = area under the concentration-time curve from time 0 to infinity.
Outcome measures
| Measure |
Group 1-Mild Hepatic Impairment
n=8 Participants
Mild hepatic impairment: Child Pugh Class A
|
Group 2-Moderate Hepatic Impairment
n=8 Participants
Moderate hepatic impairment: Child Pugh Class B
|
Group 3-Severe Hepatic Impairment
n=8 Participants
Severe hepatic impairment: Child Pugh Class C
|
Normal Hepatic Function
n=14 Participants
Normal hepatic function: No clinically significant findings
|
|---|---|---|---|---|
|
To Assess the PK AUC0-∞ of Belapectin Following a Single IV Dose of Belapectin in Subjects With Mild, Moderate, or Severe Hepatic Impairment, Compared to Healthy Subjects With Normal Hepatic Function.
|
2500000 h*ng/mL
Geometric Coefficient of Variation 26.6 • Interval 95.2 to 130.0
|
2500000 h*ng/mL
Geometric Coefficient of Variation 26 • Interval 102.0 to 117.0
|
2300000 h*ng/mL
Geometric Coefficient of Variation 21.7 • Interval 73.8 to 128.0
|
2400000 h*ng/mL
Geometric Coefficient of Variation 26.6
|
PRIMARY outcome
Timeframe: Blood PK: Day -1 to 336 hours post doseStatistical comparison of the pharmacokinetic AUC0-t parameters of belapectin in plasma from varying degrees of hepatic impairment to normal hepatic function following a single intravenous dose. AUC0-t = area under the concentration-time curve from time 0 to the last measurable concentration.
Outcome measures
| Measure |
Group 1-Mild Hepatic Impairment
n=8 Participants
Mild hepatic impairment: Child Pugh Class A
|
Group 2-Moderate Hepatic Impairment
n=8 Participants
Moderate hepatic impairment: Child Pugh Class B
|
Group 3-Severe Hepatic Impairment
n=8 Participants
Severe hepatic impairment: Child Pugh Class C
|
Normal Hepatic Function
n=14 Participants
Normal hepatic function: No clinically significant findings
|
|---|---|---|---|---|
|
To Assess the PK AUC0-t of Belapectin Following a Single IV Dose of Belapectin in Subjects With Mild, Moderate, or Severe Hepatic Impairment, Compared to Healthy Subjects With Normal Hepatic Function.
|
2440000 h*ng/mL
Geometric Coefficient of Variation 28.0
|
2410000 h*ng/mL
Geometric Coefficient of Variation 25.2
|
2210000 h*ng/mL
Geometric Coefficient of Variation 22.2
|
2320000 h*ng/mL
Geometric Coefficient of Variation 24.3
|
PRIMARY outcome
Timeframe: Blood PK: Day -1 to 336 hours post doseStatistical comparison of the pharmacokinetic Cmax parameters of belapectin in plasma from varying degrees of hepatic impairment to normal hepatic function following a single intravenous dose. Cmax = maximum observed concentration
Outcome measures
| Measure |
Group 1-Mild Hepatic Impairment
n=8 Participants
Mild hepatic impairment: Child Pugh Class A
|
Group 2-Moderate Hepatic Impairment
n=8 Participants
Moderate hepatic impairment: Child Pugh Class B
|
Group 3-Severe Hepatic Impairment
n=8 Participants
Severe hepatic impairment: Child Pugh Class C
|
Normal Hepatic Function
n=14 Participants
Normal hepatic function: No clinically significant findings
|
|---|---|---|---|---|
|
To Assess the PK Cmax of Belapectin Following a Single IV Dose of Belapectin in Subjects With Mild, Moderate, or Severe Hepatic Impairment, Compared to Healthy Subjects With Normal Hepatic Function.
|
41300 ng/mL
Geometric Coefficient of Variation 16.2
|
38300 ng/mL
Geometric Coefficient of Variation 25.4
|
37200 ng/mL
Geometric Coefficient of Variation 12.5
|
42600 ng/mL
Geometric Coefficient of Variation 20.2
|
PRIMARY outcome
Timeframe: Blood PK: Day -1 to 336 hours post doseStatistical comparison of the pharmacokinetic t1/2 parameters of belapectin in plasma from varying degrees of hepatic impairment to normal hepatic function following a single intravenous dose. t1/2 = terminal elimination half-life.
Outcome measures
| Measure |
Group 1-Mild Hepatic Impairment
n=8 Participants
Mild hepatic impairment: Child Pugh Class A
|
Group 2-Moderate Hepatic Impairment
n=8 Participants
Moderate hepatic impairment: Child Pugh Class B
|
Group 3-Severe Hepatic Impairment
n=8 Participants
Severe hepatic impairment: Child Pugh Class C
|
Normal Hepatic Function
n=14 Participants
Normal hepatic function: No clinically significant findings
|
|---|---|---|---|---|
|
To Assess the PK t1/2 of Belapectin Following a Single IV Dose of Belapectin in Subjects With Mild, Moderate, or Severe Hepatic Impairment, Compared to Healthy Subjects With Normal Hepatic Function.
|
27.4 Hours (h)
Geometric Coefficient of Variation 29.9
|
23.2 Hours (h)
Geometric Coefficient of Variation 18.9
|
24.4 Hours (h)
Geometric Coefficient of Variation 12.7
|
20.1 Hours (h)
Geometric Coefficient of Variation 31.3
|
SECONDARY outcome
Timeframe: 6 weeksTo evaluate the safety and tolerability of a single IV dose of belapectin in subjects with mild, moderate, or severe hepatic impairment, and in healthy subjects with normal hepatic function.
Outcome measures
| Measure |
Group 1-Mild Hepatic Impairment
n=14 Participants
Mild hepatic impairment: Child Pugh Class A
|
Group 2-Moderate Hepatic Impairment
n=8 Participants
Moderate hepatic impairment: Child Pugh Class B
|
Group 3-Severe Hepatic Impairment
n=8 Participants
Severe hepatic impairment: Child Pugh Class C
|
Normal Hepatic Function
n=8 Participants
Normal hepatic function: No clinically significant findings
|
|---|---|---|---|---|
|
Summary of Treatment-emergent Adverse Events
Severe TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Summary of Treatment-emergent Adverse Events
Mild TEAE
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Summary of Treatment-emergent Adverse Events
Moderate TEAE
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2-120 hours post doseCumulative amount of belapectin excreted in urine over the specified timeframe, expressed as percentage of the administered dose (fet1-t2).
Outcome measures
| Measure |
Group 1-Mild Hepatic Impairment
n=14 Participants
Mild hepatic impairment: Child Pugh Class A
|
Group 2-Moderate Hepatic Impairment
n=8 Participants
Moderate hepatic impairment: Child Pugh Class B
|
Group 3-Severe Hepatic Impairment
n=8 Participants
Severe hepatic impairment: Child Pugh Class C
|
Normal Hepatic Function
n=8 Participants
Normal hepatic function: No clinically significant findings
|
|---|---|---|---|---|
|
Fraction Percentage of Belapectin Dose Excreted in the Urine Over the Time Interval t1 to t2 (fet1-t2)
|
11.9 fet1-t2 %
Geometric Coefficient of Variation 20.6
|
14.1 fet1-t2 %
Geometric Coefficient of Variation 24.0
|
12.3 fet1-t2 %
Geometric Coefficient of Variation 20.0
|
9.7 fet1-t2 %
Geometric Coefficient of Variation 26.7
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 4
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1
n=14 participants at risk
Normal hepatic function
|
Group 2
n=8 participants at risk
Mild hepatic function
|
Group 3
n=8 participants at risk
Moderate hepatic function
|
Group 4
n=8 participants at risk
Severe hepatic function
|
|---|---|---|---|---|
|
Nervous system disorders
headache
|
21.4%
3/14 • Number of events 3 • 6 weeks
|
25.0%
2/8 • Number of events 2 • 6 weeks
|
0.00%
0/8 • 6 weeks
|
0.00%
0/8 • 6 weeks
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/14 • 6 weeks
|
0.00%
0/8 • 6 weeks
|
12.5%
1/8 • Number of events 1 • 6 weeks
|
0.00%
0/8 • 6 weeks
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/14 • 6 weeks
|
0.00%
0/8 • 6 weeks
|
12.5%
1/8 • Number of events 1 • 6 weeks
|
0.00%
0/8 • 6 weeks
|
|
General disorders
pyrexia
|
0.00%
0/14 • 6 weeks
|
0.00%
0/8 • 6 weeks
|
12.5%
1/8 • Number of events 1 • 6 weeks
|
0.00%
0/8 • 6 weeks
|
|
Vascular disorders
hypotension
|
0.00%
0/14 • 6 weeks
|
0.00%
0/8 • 6 weeks
|
0.00%
0/8 • 6 weeks
|
12.5%
1/8 • Number of events 1 • 6 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place