Clinical Trial to Evaluation the Safety and Efficacy of GR-MD-02 for the Treatment of Liver Fibrosis and Resultant Portal Hypertension in Patients With Nash Cirrhosis (NASH-CX)

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ClinicalTrials.gov Identifier: NCT02462967

Recruitment Status : Completed

First Posted : June 4, 2015

Results First Posted : October 8, 2020

Last Update Posted : October 8, 2020

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborators:

Dr. Naga Chalasani, MD, Indiana University

Dr. Stephen A. Harrison, MD, Brooke Army Medical Center

Information provided by (Responsible Party):

Galectin Therapeutics Inc.

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition	Hypertension, Portal
Interventions	Drug: GR-MD-02 Drug: Placebo
Enrollment	162

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	2 mg/kg GR MD 02	8 mg/kg GR MD 02	Placebo
Arm/Group Description	GR MD 02 in a dose of 2 mg/kg lean ...	GR MD 02 in a dose of 8 mg/kg lean ...	Phosphate buffered saline solution ...
Arm/Group Description	GR MD 02 in a dose of 2 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3	GR MD 02 in a dose of 8 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3	Phosphate buffered saline solution administered every other week over a 52 week period for a total of 26 infusions Placebo: Placebo for GR-MD-02
Period Title: Overall Study
Started	54	54	54
Completed	52	48	51
Not Completed	2	6	3

Baseline Characteristics

Arm/Group Title		2 mg/kg GR MD 02	8 mg/kg GR MD 02	Placebo	Total
Arm/Group Description		GR MD 02 in a dose of 2 mg/kg lean ...	GR MD 02 in a dose of 8 mg/kg lean ...	Phosphate buffered saline solution ...	Total of all reporting groups
Arm/Group Description		GR MD 02 in a dose of 2 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3	GR MD 02 in a dose of 8 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3	Phosphate buffered saline solution administered every other week over a 52 week period for a total of 26 infusions Placebo: Placebo for GR-MD-02	Total of all reporting groups
Overall Number of Baseline Participants		54	54	54	162
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	54 participants	54 participants	54 participants	162 participants
		59.2 (7.54)	57.1 (9.30)	58.4 (8.51)	58.3 (8.47)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	54 participants	54 participants	54 participants	162 participants
	Female	34 63.0%	43 79.6%	36 66.7%	113 69.8%
	Male	20 37.0%	11 20.4%	18 33.3%	49 30.2%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	54 participants	54 participants	54 participants	162 participants
	Hispanic or Latino	7 13.0%	13 24.1%	8 14.8%	28 17.3%
	Not Hispanic or Latino	47 87.0%	41 75.9%	46 85.2%	134 82.7%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	54 participants	54 participants	54 participants	162 participants
	American Indian or Alaska Native	0	0	0	0
	Asian	1	0	0	1
	Native Hawaiian or Other Pacific Islander	0	1	0	1
	Black or African American	0	0	0	0
	White	53	52	54	159
	More than one race	0	0	0	0
	Unknown or Not Reported	0	1	0	1
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	54 participants	54 participants	54 participants	162 participants
United States		54	54	54	162
Portal Pressure Mean (Standard Deviation) Unit of measure: Mm Hg
	Number Analyzed	54 participants	54 participants	54 participants	162 participants
		12.36 (4.288)	12.72 (4.203)	11.59 (3.994)	12.22 (4.162)

Outcome Measures

1.Primary Outcome


Title	Change in Portal Pressure at Year 1 (Change in HVPG From Baseline and 1 Year)
Description	Change in Portal Pressure at Year 1 from Baseline
Description	Change in Portal Pressure at Year 1 from Baseline
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The analysis is performed with the Full Analysis Set (FAS) in accordance with the Protocol and the Statistical Analysis Plan (SAP). The criteria for the Full Analysis Set is specified in the SAP and resulted in the Overall Number of Participants Analyzed being less than the numbers in the Participant Flow module.


Arm/Group Title	2 mg/kg GR MD 02	8 mg/kg GR MD 02	Placebo
Arm/Group Description:	GR MD 02 in a dose of 2 mg/kg lean ...	GR MD 02 in a dose of 8 mg/kg lean ...	Phosphate buffered saline solution ...
Arm/Group Description:	GR MD 02 in a dose of 2 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3	GR MD 02 in a dose of 8 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3	Phosphate buffered saline solution administered every other week over a 52 week period for a total of 26 infusions Placebo: Placebo for GR-MD-02
Overall Number of Participants Analyzed	48	45	50
Mean (Standard Deviation) Unit of Measure: mm HG
	-0.39 (4.018)	-0.24 (3.100)	0.19 (3.240)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	2 mg/kg GR MD 02, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	1.000
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	8 mg/kg GR MD 02, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	1.000
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

2.Secondary Outcome


Title	The Baseline-adjusted Mean Change in the Collagen Proportional Area (%), CPA
Description	The baseline-adjusted mean change in the CPA at 1 year as determined b...
Description	The baseline-adjusted mean change in the CPA at 1 year as determined by digital morphometric analysis of liver biopsies. Collagen proportionate area (CPA) measurement is a technique that quantifies fibrous tissue in liver biopsies by measuring the amount of collagen deposition as a proportion of the total biopsy area. CPA predicts clinical outcomes in patients with liver disease and can sub-classify cirrhosis.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	2 mg/kg GR MD 02	8 mg/kg GR MD 02	Placebo
Arm/Group Description:	GR MD 02 in a dose of 2 mg/kg lean ...	GR MD 02 in a dose of 8 mg/kg lean ...	Phosphate buffered saline solution ...
Arm/Group Description:	GR MD 02 in a dose of 2 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3	GR MD 02 in a dose of 8 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3	Phosphate buffered saline solution administered every other week over a 52 week period for a total of 26 infusions Placebo: Placebo for GR-MD-02
Overall Number of Participants Analyzed	46	41	45
Mean (Standard Deviation) Unit of Measure: Percent Area (%)
	1.2 (5.54)	0.1 (5.68)	1.3 (8.22)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	2 mg/kg GR MD 02, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.447
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	8 mg/kg GR MD 02, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.921
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

3.Secondary Outcome


Title	The Number (Percentage) of Subjects Who Have at Least a One Stage Change in Ishak Assessment From Liver Biology Histopathology. Histopathological Staging of Fibrosis
Description	The number (percentage) of subjects who have at least a one stage chan...
Description	The number (percentage) of subjects who have at least a one stage change in Ishak histopathological staging of fibrosis at 1 year as assessed on liver biopsy. Liver biopsy is the accepted standard for histologic assessment of liver disease activity and fibrosis. Ishak assessments on liver biopsy range from 0=no fibrosis to 6=cirrhosis.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	2 mg/kg GR MD 02	8 mg/kg GR MD 02	Placebo
Arm/Group Description:	GR MD 02 in a dose of 2 mg/kg lean ...	GR MD 02 in a dose of 8 mg/kg lean ...	Phosphate buffered saline solution ...
Arm/Group Description:	GR MD 02 in a dose of 2 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3	GR MD 02 in a dose of 8 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3	Phosphate buffered saline solution administered every other week over a 52 week period for a total of 26 infusions Placebo: Placebo for GR-MD-02
Overall Number of Participants Analyzed	54	54	54
Measure Type: Count of Participants Unit of Measure: Participants
	17 31.5%	13 24.1%	14 25.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	2 mg/kg GR MD 02, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.522
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	8 mg/kg GR MD 02, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	1.000
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

4.Secondary Outcome


Title	The Baseline-adjusted Mean Change in Liver Stiffness
Description	The baseline-adjusted mean change in liver stiffness as determined by ...
Description	The baseline-adjusted mean change in liver stiffness as determined by FibroScan score 14 to 28 days after final infusion. FibroScan is a device that measures scarring by measuring the stiffness of your liver.The fibrosis result is measured in kilopascals (kPa) It's normally between 2 and 6 kPa. The highest possible result is 75 kPa. Many people with liver disease(s) have a result that's higher than the normal range.
Time Frame	14 to 28 days after final infusion

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	2 mg/kg GR MD 02	8 mg/kg GR MD 02	Placebo
Arm/Group Description:	GR MD 02 in a dose of 2 mg/kg lean ...	GR MD 02 in a dose of 8 mg/kg lean ...	Phosphate buffered saline solution ...
Arm/Group Description:	GR MD 02 in a dose of 2 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3	GR MD 02 in a dose of 8 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3	Phosphate buffered saline solution administered every other week over a 52 week period for a total of 26 infusions Placebo: Placebo for GR-MD-02
Overall Number of Participants Analyzed	54	54	54
Mean (Standard Deviation) Unit of Measure: Kilopascals, kPa
	-0.59 (2.00)	-2.76 (2.02)	-0.79 (2.02)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	2 mg/kg GR MD 02, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.943
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	8 mg/kg GR MD 02, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.492
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

5.Secondary Outcome


Title	The Baseline-adjusted Mean Change in Methacetin Breath Test (MBT), Measured in Percentage
Description	The baseline-adjusted mean change in the metabolic capacity of the liv...
Description	The baseline-adjusted mean change in the metabolic capacity of the liver as determined the methacetin breath test (MBT) at 14 to 28 days after final infusion. The results obtained from the MBT medical device are expressed as delta over baseline (DOB), which expresses the change in 13CO2/12CO2 ratio in comparison to the baseline measurement. It can be transformed into the percentage of 13C dose recovered over time (PDR) after the ingestion of Methacetin, and the cumulative PDR (CPDR), the rate at which 13C substrate is metabolized, derived from the breath 13C/12C ratio.
Time Frame	14 to 28 days after final infusion

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	2 mg/kg GR MD 02	8 mg/kg GR MD 02	Placebo
Arm/Group Description:	GR MD 02 in a dose of 2 mg/kg lean ...	GR MD 02 in a dose of 8 mg/kg lean ...	Phosphate buffered saline solution ...
Arm/Group Description:	GR MD 02 in a dose of 2 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3	GR MD 02 in a dose of 8 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3	Phosphate buffered saline solution administered every other week over a 52 week period for a total of 26 infusions Placebo: Placebo for GR-MD-02
Overall Number of Participants Analyzed	54	54	54
Mean (Standard Deviation) Unit of Measure: percent
	-40.51 (34.45)	-20.57 (38.00)	-51.00 (35.17)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	2 mg/kg GR MD 02, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.832
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	8 mg/kg GR MD 02, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.558
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

6.Secondary Outcome


Title	The Number (Percentage) of Subjects Who Have at Least a One Stage Change in Brunt-Kleiner Assessment on Liver Biopsy Histopathological Staging of Fibrosis
Description	The number (percentage) of subjects who have at least a one stage chan...
Description	The number (percentage) of subjects who have at least a one stage change in Brunt-Kleiner histopathological staging of fibrosis at 1 year as assessed on liver biopsy. Liver biopsy is the accepted standard for histologic assessment of liver disease activity and fibrosis. Brunt-Kleiner assessments on liver biopsy range from 0 (absent) to 4 (cirrhosis).
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	2 mg/kg GR MD 02	8 mg/kg GR MD 02	Placebo
Arm/Group Description:	GR MD 02 in a dose of 2 mg/kg lean ...	GR MD 02 in a dose of 8 mg/kg lean ...	Phosphate buffered saline solution ...
Arm/Group Description:	GR MD 02 in a dose of 2 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3	GR MD 02 in a dose of 8 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3	Phosphate buffered saline solution administered every other week over a 52 week period for a total of 26 infusions Placebo: Placebo for GR-MD-02
Overall Number of Participants Analyzed	54	54	54
Measure Type: Count of Participants Unit of Measure: Participants
	3 5.6%	2 3.7%	1 1.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	2 mg/kg GR MD 02, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.362
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	8 mg/kg GR MD 02, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.602
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

7.Secondary Outcome


Title	The Number (Percentage) of Subjects That Develop a Clinical Complication of Cirrhosis
Description	The number (percentage) of subjects with progression of cirrhosis at 1...
Description	The number (percentage) of subjects with progression of cirrhosis at 1 year, defined as the development of any of the following clinical complications: esophageal variceal hemorrhage or portal hypertensive gastropathy hemorrhage (confirmed by endoscopy or interventional radiology); clinically apparent ascites; spontaneous bacterial peritonitis; overt hepatic encephalopathy; an increase in Child-Turcotte-Pugh score ≥2 points; newly diagnosed varices in a subject without prior varices; progression from small to medium or large varices; qualification for liver transplant defined as a Model for End-Stage Liver Disease (MELD) score ≥15; listing for a liver transplant or the performance of a liver transplant; liver-related mortality
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	2 mg/kg GR MD 02	8 mg/kg GR MD 02	Placebo
Arm/Group Description:	GR MD 02 in a dose of 2 mg/kg lean ...	GR MD 02 in a dose of 8 mg/kg lean ...	Phosphate buffered saline solution ...
Arm/Group Description:	GR MD 02 in a dose of 2 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3	GR MD 02 in a dose of 8 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3	Phosphate buffered saline solution administered every other week over a 52 week period for a total of 26 infusions Placebo: Placebo for GR-MD-02
Overall Number of Participants Analyzed	54	54	54
Measure Type: Count of Participants Unit of Measure: Participants
	10 18.5%	11 20.4%	12 22.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	2 mg/kg GR MD 02, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.633
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	8 mg/kg GR MD 02, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.814
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	2 mg/kg GR MD 02		8 mg/kg GR MD 02		Placebo
Arm/Group Description	GR MD 02 in a dose of 2 mg/kg lean ...		GR MD 02 in a dose of 8 mg/kg lean ...		Phosphate buffered saline solution ...
Arm/Group Description	GR MD 02 in a dose of 2 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3		GR MD 02 in a dose of 8 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3		Phosphate buffered saline solution administered every other week over a 52 week period for a total of 26 infusions Placebo: Placebo for GR-MD-02
All-Cause Mortality
	2 mg/kg GR MD 02		8 mg/kg GR MD 02		Placebo
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	1/53 (1.89%)		0/54 (0.00%)		0/54 (0.00%)
Serious Adverse Events Serious Adverse Events
	2 mg/kg GR MD 02		8 mg/kg GR MD 02		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/53 (18.87%)		16/54 (29.63%)		12/54 (22.22%)
Blood and lymphatic system disorders
ANAEMIA ^†	0/53 (0.00%)	0	1/54 (1.85%)	1	2/54 (3.70%)	2
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA ^†	0/53 (0.00%)	0	2/54 (3.70%)	2	0/54 (0.00%)	0
ARTERIOSCLEROSIS CORONARY ARTERY ^†	1/53 (1.89%)	1	0/54 (0.00%)	0	0/54 (0.00%)	0
ATRIAL FIBRILLATION ^†	0/53 (0.00%)	0	1/54 (1.85%)	1	0/54 (0.00%)	0
CARDIAC FAILURE CONGESTIVE ^†	0/53 (0.00%)	0	1/54 (1.85%)	1	0/54 (0.00%)	0
Gastrointestinal disorders
ABDOMINAL PAIN ^†	2/53 (3.77%)	2	0/54 (0.00%)	0	1/54 (1.85%)	1
HAEMATEMESIS ^†	1/53 (1.89%)	1	1/54 (1.85%)	1	0/54 (0.00%)	0
DIARRHOEA ^†	0/53 (0.00%)	0	0/54 (0.00%)	0	1/54 (1.85%)	1
GASTROINTESTINAL HAEMORRHAGE ^†	0/53 (0.00%)	0	1/54 (1.85%)	1	0/54 (0.00%)	0
HAEMATOCHEZIA ^†	0/53 (0.00%)	0	0/54 (0.00%)	0	1/54 (1.85%)	1
OESOPHAGEAL HAEMORRHAGE ^†	0/53 (0.00%)	0	1/54 (1.85%)	1	0/54 (0.00%)	0
PANCREATITIS ACUTE ^†	0/53 (0.00%)	0	1/54 (1.85%)	1	0/54 (0.00%)	0
SMALL INTESTINAL OBSTRUCTION ^†	0/53 (0.00%)	0	0/54 (0.00%)	0	1/54 (1.85%)	1
General disorders
HERNIA PAIN ^†	1/53 (1.89%)	1	0/54 (0.00%)	0	0/54 (0.00%)	0
NON-CARDIAC CHEST PAIN ^†	0/53 (0.00%)	0	1/54 (1.85%)	1	0/54 (0.00%)	0
PYREXIA ^†	0/53 (0.00%)	0	0/54 (0.00%)	0	1/54 (1.85%)	1
Infections and infestations
SEPSIS ^†	0/53 (0.00%)	0	2/54 (3.70%)	2	0/54 (0.00%)	0
ABSCESS OF EYELID ^†	1/53 (1.89%)	1	0/54 (0.00%)	0	0/54 (0.00%)	0
CELLULITIS ^†	0/53 (0.00%)	0	1/54 (1.85%)	1	0/54 (0.00%)	0
ESCHERICHIA BACTERAEMIA ^†	0/53 (0.00%)	0	0/54 (0.00%)	0	1/54 (1.85%)	1
GASTROENTERITIS SALMONELLA ^†	0/53 (0.00%)	0	1/54 (1.85%)	1	0/54 (0.00%)	0
PNEUMONIA ^†	0/53 (0.00%)	0	0/54 (0.00%)	0	1/54 (1.85%)	1
Injury, poisoning and procedural complications
DURAL TEAR ^†	0/53 (0.00%)	0	0/54 (0.00%)	0	1/54 (1.85%)	1
STOMA COMPLICATION ^†	1/53 (1.89%)	1	0/54 (0.00%)	0	0/54 (0.00%)	0
Metabolism and nutrition disorders
HYPONATRAEMIA ^†	0/53 (0.00%)	0	1/54 (1.85%)	1	0/54 (0.00%)	0
Musculoskeletal and connective tissue disorders
ARTHRALGIA ^†	1/53 (1.89%)	1	0/54 (0.00%)	0	0/54 (0.00%)	0
OSTEOARTHRITIS ^†	0/53 (0.00%)	0	0/54 (0.00%)	0	1/54 (1.85%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN ^†	1/53 (1.89%)	1	0/54 (0.00%)	0	0/54 (0.00%)	0
Nervous system disorders
HYPOAESTHESIA ^†	0/53 (0.00%)	0	0/54 (0.00%)	0	1/54 (1.85%)	1
TRANSIENT ISCHAEMIC ATTACK ^†	0/53 (0.00%)	0	1/54 (1.85%)	1	0/54 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM ^†	1/53 (1.89%)	1	0/54 (0.00%)	0	0/54 (0.00%)	0
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	2 mg/kg GR MD 02		8 mg/kg GR MD 02		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	52/53 (98.11%)		48/54 (88.89%)		53/54 (98.15%)
Eye disorders
Abdominal pain ^†	5/53 (9.43%)	5	3/54 (5.56%)	3	7/54 (12.96%)	7
Gastrointestinal disorders
Nausea ^†	14/53 (26.42%)	14	8/54 (14.81%)	8	11/54 (20.37%)	11
Diarrhoea ^†	12/53 (22.64%)	12	8/54 (14.81%)	8	11/54 (20.37%)	11
Abdominal pain upper ^†	8/53 (15.09%)	8	8/54 (14.81%)	8	13/54 (24.07%)	13
Vomiting ^†	7/53 (13.21%)	7	7/54 (12.96%)	7	2/54 (3.70%)	2
General disorders
Fatigue ^†	9/53 (16.98%)	9	9/54 (16.67%)	9	10/54 (18.52%)	10
Oedema peripheral ^†	8/53 (15.09%)	8	4/54 (7.41%)	4	7/54 (12.96%)	7
Infections and infestations
Nasopharyngitis ^†	14/53 (26.42%)	14	5/54 (9.26%)	5	8/54 (14.81%)	8
Urinary tract infection ^†	8/53 (15.09%)	8	6/54 (11.11%)	6	9/54 (16.67%)	9
Sinusitis ^†	6/53 (11.32%)	6	7/54 (12.96%)	7	4/54 (7.41%)	4
Upper respiratory tract infection ^†	8/53 (15.09%)	8	4/54 (7.41%)	4	5/54 (9.26%)	5
Bronchitis ^†	7/53 (13.21%)	7	3/54 (5.56%)	3	5/54 (9.26%)	5
Injury, poisoning and procedural complications
Contusion ^†	10/53 (18.87%)	10	3/54 (5.56%)	3	6/54 (11.11%)	6
Musculoskeletal and connective tissue disorders
Arthralgia ^†	6/53 (11.32%)	6	9/54 (16.67%)	9	1/54 (1.85%)	1
Muscle spasms ^†	8/53 (15.09%)	8	3/54 (5.56%)	3	4/54 (7.41%)	4
Pain in extremity ^†	4/53 (7.55%)	4	4/54 (7.41%)	4	6/54 (11.11%)	6
Back pain ^†	3/53 (5.66%)	3	7/54 (12.96%)	7	2/54 (3.70%)	2
Nervous system disorders
Headache ^†	9/53 (16.98%)	9	6/54 (11.11%)	6	9/54 (16.67%)	9
Dizziness ^†	2/53 (3.77%)	2	5/54 (9.26%)	5	9/54 (16.67%)	9
Skin and subcutaneous tissue disorders
Rash ^†	5/53 (9.43%)	5	5/54 (9.26%)	5	6/54 (11.11%)	6
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

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Name/Title:	Vice President of Regulatory Affairs
Organization:	Galectin Therapeutics
Phone:	678-620-3186
EMail:	horton@galectintherapeutics.com

Publications of Results:

Chalasani N, Abdelmalek MF, Garcia-Tsao G, Vuppalanchi R, Alkhouri N, Rinella M, Noureddin M, Pyko M, Shiffman M, Sanyal A, Allgood A, Shlevin H, Horton R, Zomer E, Irish W, Goodman Z, Harrison SA, Traber PG; Belapectin (GR-MD-02) Study Investigators. Effects of Belapectin, an Inhibitor of Galectin-3, in Patients With Nonalcoholic Steatohepatitis With Cirrhosis and Portal Hypertension. Gastroenterology. 2020 Apr;158(5):1334-1345.e5. doi: 10.1053/j.gastro.2019.11.296. Epub 2019 Dec 5.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Are VS, Vuppalanchi R, Vilar-Gomez E, Chalasani N. Enhanced Liver Fibrosis Score Can Be Used to Predict Liver-Related Events in Patients With Nonalcoholic Steatohepatitis and Compensated Cirrhosis. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1292-1293.e3. doi: 10.1016/j.cgh.2020.06.070. Epub 2020 Jul 3.

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Responsible Party:	Galectin Therapeutics Inc.
ClinicalTrials.gov Identifier:	NCT02462967
Other Study ID Numbers:	GT-026
First Submitted:	June 2, 2015
First Posted:	June 4, 2015
Results First Submitted:	August 17, 2020
Results First Posted:	October 8, 2020
Last Update Posted:	October 8, 2020

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