Trial Outcomes & Findings for Clinical Trial to Evaluate Efficacy of GR-MD-02 for Treatment of Liver Fibrosis in Patients With NASH With Advanced Fibrosis (NCT NCT02421094)
NCT ID: NCT02421094
Last Updated: 2020-10-08
Results Overview
Difference in baseline adjusted mean change in liver fibrosis of corrected T1 (cT1) mapping with LiverMultiScan (LMS). LiverMultiScan is CE marked as a class IIa medical device. Corrected T1 (cT1) is a Magnetic Resonance (MR) relaxation parameter/measure from the device.The measure cT1 can be compared across different Magnetic Resonance Imaging (MRI) systems and sites. It is an emerging biomarker for rapid quantification of hepatic fibro-inflammatory disease. In unhealthy tissue, such as in inflamed and fibrotic tissues, measures result in longer cT1-relaxation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
16 weeks
Results posted on
2020-10-08
Participant Flow
Participant milestones
| Measure |
GR-MD-02 8 mg/kg
Active
GR-MD-02: GM-MD-02 active
|
Placebo
Placebo
Placebo: Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Trial to Evaluate Efficacy of GR-MD-02 for Treatment of Liver Fibrosis in Patients With NASH With Advanced Fibrosis
Baseline characteristics by cohort
| Measure |
GR-MD-02 8 mg/kg
n=15 Participants
Active
GR-MD-02: GM-MD-02 active
|
Placebo
n=15 Participants
Placebo
Placebo: Placebo
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.7 years
STANDARD_DEVIATION 6.19 • n=5 Participants
|
56.7 years
STANDARD_DEVIATION 6.15 • n=7 Participants
|
58.2 years
STANDARD_DEVIATION 6.17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeksDifference in baseline adjusted mean change in liver fibrosis of corrected T1 (cT1) mapping with LiverMultiScan (LMS). LiverMultiScan is CE marked as a class IIa medical device. Corrected T1 (cT1) is a Magnetic Resonance (MR) relaxation parameter/measure from the device.The measure cT1 can be compared across different Magnetic Resonance Imaging (MRI) systems and sites. It is an emerging biomarker for rapid quantification of hepatic fibro-inflammatory disease. In unhealthy tissue, such as in inflamed and fibrotic tissues, measures result in longer cT1-relaxation.
Outcome measures
| Measure |
GR-MD-02 8 mg/kg
n=15 Participants
Active
GR-MD-02: GM-MD-02 active
|
Placebo
n=15 Participants
Placebo
Placebo: Placebo
|
|---|---|---|
|
Mean Change in Liver Fibrosis of Corrected T1 (cT1) Mapping (LiverMultiScan -LMS)
|
19.15 milliseconds (ms)
Interval -7.7 to 43.5
|
1.25 milliseconds (ms)
Interval -7.7 to 43.5
|
SECONDARY outcome
Timeframe: 16 weeksBaseline-adjusted change in liver stiffness as measured by MR-elastography. Magnetic resonance elastography (MRE) is a technology that uses MRI imaging with low-frequency vibrations to create a visual map (elastogram) that shows stiffness of body tissues. Currently, MRE is used to detect stiffening of the liver caused by fibrosis and inflammation in chronic liver disease. Liver stiffness increases with liver damage/disease.
Outcome measures
| Measure |
GR-MD-02 8 mg/kg
n=15 Participants
Active
GR-MD-02: GM-MD-02 active
|
Placebo
n=15 Participants
Placebo
Placebo: Placebo
|
|---|---|---|
|
Baseline-adjusted Change in Liver Stiffness With MR-elastography (MRE)
|
0.17 Kilopascals, kPa
Standard Deviation 0.55
|
0.18 Kilopascals, kPa
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: 16 weeksBaseline-adjusted change in liver stiffness as measured by FibroScan® scores. FibroScan 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. Many people with liver disease(s) have a result that's higher than the normal range.
Outcome measures
| Measure |
GR-MD-02 8 mg/kg
n=15 Participants
Active
GR-MD-02: GM-MD-02 active
|
Placebo
n=15 Participants
Placebo
Placebo: Placebo
|
|---|---|---|
|
Baseline-adjusted Change in Liver Stiffness by FibroScan®
|
1.11 Kilopascals, kPa
Standard Deviation 9.51
|
-2.32 Kilopascals, kPa
Standard Deviation 5.87
|
Adverse Events
GR-MD-02 8 mg/kg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
GR-MD-02 8 mg/kg
n=15 participants at risk
Active
GR-MD-02: GM-MD-02 active
|
Placebo
n=15 participants at risk
Placebo
Placebo: Placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
13.3%
2/15 • Number of events 2 • 16 weeks
|
0.00%
0/15 • 16 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
0.00%
0/15 • 16 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/15 • 16 weeks
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
Constipation
|
13.3%
2/15 • Number of events 2 • 16 weeks
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
26.7%
4/15 • Number of events 4 • 16 weeks
|
13.3%
2/15 • Number of events 2 • 16 weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
0.00%
0/15 • 16 weeks
|
|
Gastrointestinal disorders
Nausea
|
20.0%
3/15 • Number of events 3 • 16 weeks
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
|
General disorders
Chest pain
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
0.00%
0/15 • 16 weeks
|
|
General disorders
Cyst
|
0.00%
0/15 • 16 weeks
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
|
General disorders
Oedema peripheral
|
0.00%
0/15 • 16 weeks
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
|
General disorders
Food allergy
|
0.00%
0/15 • 16 weeks
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
|
Infections and infestations
Body tinea
|
0.00%
0/15 • 16 weeks
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/15 • 16 weeks
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
|
Infections and infestations
Diverticulitis
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
0.00%
0/15 • 16 weeks
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/15 • 16 weeks
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
|
Infections and infestations
Sinusitis
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
0.00%
0/15 • 16 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
|
Infections and infestations
Urinary tract infection
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
0.00%
0/15 • 16 weeks
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
|
Injury, poisoning and procedural complications
Muscle sprain
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/15 • 16 weeks
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
|
Injury, poisoning and procedural complications
Tendon injury
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
0.00%
0/15 • 16 weeks
|
|
Cardiac disorders
Cardiac murmur
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
13.3%
2/15 • Number of events 2 • 16 weeks
|
0.00%
0/15 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/15 • 16 weeks
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
0.00%
0/15 • 16 weeks
|
|
Nervous system disorders
Dizziness
|
13.3%
2/15 • Number of events 2 • 16 weeks
|
0.00%
0/15 • 16 weeks
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
|
Nervous system disorders
Lethargy
|
0.00%
0/15 • 16 weeks
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
|
Nervous system disorders
Tension headache
|
0.00%
0/15 • 16 weeks
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
0.00%
0/15 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/15 • 16 weeks
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
0.00%
0/15 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/15 • 16 weeks
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
0.00%
0/15 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Palmar erythematous
|
0.00%
0/15 • 16 weeks
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
0.00%
0/15 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
0.00%
0/15 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/15 • 16 weeks
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
6.7%
1/15 • Number of events 1 • 16 weeks
|
13.3%
2/15 • Number of events 2 • 16 weeks
|
Additional Information
Vice President of Regulatory Affairs
Galectin Therapeutics
Phone: 678-620-3186
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place