Study Evaluating the Efficacy and Safety of Belapectin fo... | NCT04365868

Label	Type	Description	Intervention Names
belapectin 2 mg/kg lean body mass (LBM)	Experimental	Phase 2b: Belapectin 2 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose	Drug: belapectin
belapectin 4 mg/kg lean body mass (LBM)	Experimental	Phase 2b: Belapectin 4 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose	Drug: belapectin
Placebo	Placebo Comparator	Phase 2b: Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3:Placebo, administered intravenously (IV) every other week for 78 weeks (18 months)	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
belapectin	Drug	intravenous	belapectin 2 mg/kg lean body mass (LBM) belapectin 4 mg/kg lean body mass (LBM)

Measure	Description	Time Frame
Proportion of Patients in the Belapectin Treatment Groups Who Develop New Esophageal Varices at 78 Weeks [18 Months] of Treatment Compared to Placebo	Proportion of patients in the belapectin treatment groups who develop new esophageal varices at 78 weeks [18 months] of treatment compared to placebo.	At 78 weeks [18 months]

Measure	Description	Time Frame
Efficacy: Cumulative Incidence Rate of Patients in the Belapectin Treatment Groups, Compared to Placebo, Who Develop Varices (Esophageal or Gastric) Requiring Treatment	Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop varices (esophageal or gastric) requiring treatment.	Through study end, 78 weeks or 156 weeks

Measure	Description	Time Frame
Exploratory Efficacy:Change in Liver Stiffness Measurement (LSM), Baseline-adjusted, as Determined by Vibration Controlled Transient Elastography (VCTE) (FibroScan) Exams During Phase 2b and Phase 3	Exploratory Efficacy: Change in liver stiffness measurement (LSM), baseline-adjusted, as determined by vibration controlled transient elastography (VCTE) (FibroScan) exams during Phase 2b and Phase 3	Through study end, 78 weeks or 156 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Each subject must meet all of the following criteria to be enrolled in this study:

Is male or female, ≥ 18 and ≤ 75 years of age at the time of Screening.
Is willing and able to provide written informed consent prior to the initiation of any study-specific procedures.
Has evidence of portal hypertension, with either one of the following:
1. platelet count <150,000/mm3
  
  OR
2. documented hepatic venous pressure gradient (HVPG) measurement >6 mmHg
  
  OR
3. at least two of the following:
  - spleen size ≥14 cm (documented by ultrasound, MRI, or CT scan)
  - abdominal collateral circulation (documented by ultrasound, MRI, or CT scan or physical examination, ie, caput medusae)
  - documented liver transient elastography (eg, FibroScan) ≥20 kilopascals (kPa).
  - aspartate aminotransferase (AST)/alanine aminotransferase (ALT) >1.
Has a history confirming nonalcoholic steatohepatitis (NASH) cirrhosis, with at least one of the following:
- There is a historical liver biopsy showing cirrhosis with steatohepatitis. There is no evidence for a competing etiology for the cirrhosis.
- There is a historical liver biopsy showing steatohepatitis, and there is evidence of cirrhosis from clinical or imaging data or a second liver biopsy showing cirrhosis without all features of NASH (as the histological NASH lesions may have burnt out). There is no evidence for a competing etiology. There is at least 1 co-existing metabolic comorbidity at Screening: obesity (with either body mass index [BMI] ≥30 kg/m2 or waist circumference ≥102 cm [40 in, men] or ≥88 cm [35 in, women], or by ethnically appropriate cutpoints); hypertension (either on anti hypertensive drug therapy for at least 1 year or systolic/diastolic blood pressure (BP) >140/80 mm Hg); Type 2 diabetes (glycated hemoglobin [HbA1c] ≥6.5%, or on anti-diabetic medication for at least 1 year); or dyslipidemia (triglycerides ≥150 mg/dL or on drug therapy for hypertriglyceridemia for at least 6 months; high-density lipoprotein cholesterol ≤40 mg/dL [men] or ≤50 mg/dL [women]) to corroborate a diagnosis of nonalcoholic fatty liver disease (NAFLD).
- There is a historical liver biopsy showing cirrhosis with steatosis but not steatohepatitis. There is no evidence for a competing etiology. There are at least 2 co-existing (or history of) metabolic comorbidities (with obesity or diabetes being one of them) to corroborate a diagnosis of NAFLD.
- There is a historical liver biopsy showing steatosis but now with cirrhosis either by clinical examination, imaging, or biopsy. If there is a current biopsy, it does not show evidence of steatosis or steatohepatitis as histological lesions may have burned out. There is no evidence for a competing etiology. There are at least 2 co existing (or history of) metabolic comorbidities (with obesity or diabetes being one of them) to corroborate a diagnosis of NAFLD.
- Patient with cirrhosis with current or previous imaging showing steatosis. There is no liver histology available. There is no evidence for a competing etiology. There are at least two co-existing or history of metabolic comorbidities with obesity or diabetes being one of them to corroborate a diagnosis of NAFLD.
- For patients not meeting the above mentioned criteria, a screening liver biopsy is necessary.
Note: All liver biopsy blocks and/or slides for eligibility assessments (including those from historical biopsies) will be reviewed by the central study pathologist while the subject is in Screening. Results from the central study pathologist must be available before the subject is randomized.
Absence of hepatocellular carcinoma (HCC) by valid imaging (eg, ultrasound, CT scan, or MRI) within 6 months prior to randomization. If no such imaging result is available, then ultrasound imaging should be performed as part of standard of care.
Patients with diabetes mellitus can be enrolled, if they are adequately controlled on a stable dose or doses of antidiabetic medication(s) for at least 3 months before Screening, and their screening HbA1c is ≤9.5%.
Patients on vitamin E or pioglitazone can be enrolled if they are on a stable dose and regimen for at least 3 months before screening, and the dose is expected to be held constant during the trial.
Patients on a statin can be enrolled if they are on a stable regimen for at least 3 months before Screening, and expected to be held stable during the trial.
Is not pregnant and must have a negative serum pregnancy test result prior to randomization.
Is of non-childbearing potential or if a fertile man or woman participating in heterosexual relations, agrees to use two acceptable means of contraception (ie, 2 effective methods of contraception, one of which must be a physical barrier method [eg, male or female condom, diaphragm] when combined with a highly effective method of contraception [ie, a method with a failure rate of <1% per year when used consistently and correctly]) throughout his/her participation in this study and for 90 days after discontinuation of study treatment.

Highly effective forms of contraception include:
- combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (such as oral, intravaginal, transdermal) methods
- progestogen-only hormonal contraception associated with inhibition of ovulation (such as oral, injectable, implantable)
- hormone-releasing intrauterine system (IUS)
- intrauterine device (IUD)
- bilateral tubal occlusion
- a vasectomized partner, provided that partner is the sole sexual partner of the women of childbearing potential trial participant and that the vasectomized partner has received medical assessment of the surgical success
- sexual abstinence (ie, a refraining from heterosexual intercourse during the entire period of the clinical trial, if it is the preferred and usual lifestyle of the subject).
Surgically sterile males and females are not required to use contraception provided they have been considered surgically sterile for at least 6 months. Surgical sterility includes history of surgically successful vasectomy, hysterectomy, or bilateral salpingo-oophorectomy. Postmenopausal women who have been amenorrheic for at least 2 years at the time of Screening will be considered sterile.
If a lactating woman, agrees to discontinue nursing before the start of study treatment and refrain from nursing until 90 days after the last dose of study treatment.
If a man, agrees to refrain from sperm donation throughout the study period and for a period of 90 days following the last dose of investigational medicinal product (IMP). Female subjects may not begin a cycle of ova donation or harvest throughout the study period and for a period of 90 days following the last dose of IMP.

Exclusion Criteria:

Subjects meeting any of the following criteria will be excluded from the study:

Presence of esophageal, gastroesophageal, or isolated gastric varices, based on an upper gastrointestinal (GI) esophagogastroduodenoscopy (EGD) exam conducted during Screening. Patients with portal hypertensive gastropathy could be enrolled.
History of hepatic cirrhosis decompensation including any episode of variceal bleeding, ascites not controlled by medication, spontaneous bacterial peritonitis or overt hepatic encephalopathy (West Haven grade ≥2 as assessed by the principal investigator), OR develops signs of hepatic cirrhosis decompensation during Screening.
Known or suspected abuse of alcohol (>20 g/day for women or >30 g/day for men [on average per day]), as per medical history. Significant alcohol consumption is defined as more than 20 grams per day in females and more than 30 grams per day in males. On average, a standard drink in the United States is considered to be 14 grams of alcohol, equivalent to 12 fluid ounces of regular beer (5% alcohol), 5 fluid ounces of table wine (12% alcohol), or 1.5 fluid ounces of 80 proof spirits (40% alcohol).
Alcohol dependence (ie, a score >8 on the Alcohol Use Disorders Identification Test)
Narcotics or any other drug abuse or dependence in the last 5 years
Prior trans-jugular intrahepatic portal-systemic (TIPS) shunt procedure
Documented causes of liver disease other than NASH, including but not restricted to:
- Viral hepatitis, unless eradicated at least 3 years prior to Screening
  - acute hepatitis A infection (presence of hepatitis A immunoglobulin M [IgM] at Screening)
  - positive hepatitis B surface antigen
  - positive hepatitis C virus (HCV) ribonucleic acid (to be performed prior to randomization in case of positive HCV antibody)
- Documented drug-induced liver disease
- Alcoholic liver disease
- Autoimmune hepatitis
- Wilson's disease
- Hemochromatosis
- Primary biliary cholangitis
- Primary sclerosing cholangitis
- Genetic hemochromatosis
- History or planned liver transplantation
- Alpha-1 antitrypsin deficiency
History of human immunodeficiency virus (HIV), or positive HIV test at Screening
Any of the following test or score:
- serum alanine aminotransferase (ALT) > 5 × upper limit of normal (ULN)*
- serum aspartate aminotransferase (AST) > 5 × ULN*
  
  *Screening values will be obtained at Screening Visit 1 (SV1) and Screening Visit 2(SV2) (which will be separated by 2 to 4 weeks). A second screening value that is >50% higher than the first value should prompt re-evaluation of the severity of the underlying liver disease and eligibility for this trial. If a transaminase level at SV2 is >33% different from the level at SV1, then additional measurements should be performed at Screening Visit 3 (SV3). In such cases, the baseline transaminase levels will be established for subjects using the mean value of 4 evaluations [ie, at SV1, SV2, SV3, and Baseline (ie, pre-dose during Visit 1)].
- serum alkaline phosphatase (ALP) > 2 × ULN
- mean platelet count < 50,000/mm3
- total bilirubin ≥ 2.0 mg/dL (subjects with a documented history of Gilbert's syndrome can be enrolled if the direct bilirubin is within normal reference range)
- model for end-stage liver disease (MELD) score ≥12
- Child-Turcotte-Pugh (CTP) Score ≥7 Note: Following Phase 2b, subjects with CTP scores ≥7 may be enrolled if recommended* by the Data Safety Monitoring Board (DSMB) and approved by the Trial Steering Committee (TSC), based on the planned interim analysis (IA). [*based on DSMB review of preliminary results from a separate hepatic impairment clinical trial (Study GT-032) which is assessing belapectin safety and pharmacokinetic (PK) in cirrhotic subjects with CTP scores ≥7.
- estimated glomerular filtration rate < 45 mL/min* *Note: per Modification of Diet in Renal Disease algorithm
Taking an angiotensin converting enzyme inhibitor, angiotensin II receptor blocker, or β-1 selective adrenergic receptor inhibitor, unless on a stable regimen for at least 3 months prior to Screening and no changes in the regimen are anticipated during the study. Subjects taking a non-selective beta blocker are not eligible to be enrolled (Investigators are encouraged to substitute another medication, if clinically warranted).
History of major surgery during Screening.
History of a solid organ transplant requiring immunosuppressive therapy.
History of bariatric surgery within 1 year of randomization, or plan to undergo bariatric surgery during the study.
Has positive screening test for illicit drugs of abuse at Screening.
Has participated in an investigational new drug study within 30 days or 5 half-lives whichever is longer, prior to randomization.
Has a history of malignancy within 5 years of randomization, except for basal cell carcinoma, squamous cell carcinoma, and adequately treated in situ uterine cervical cancer.
Has clinically significant cardiovascular disease (eg, uncontrolled hypertension, myocardial infarction, unstable angina), New York Heart Association Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring intervention (eg, pacemaker/ablation) or Grade II or greater peripheral vascular disease.
Has a history of clinically significant hematologic, renal, hepatic, pulmonary, neurological, psychiatric, gastrointestinal, systemic inflammatory, metabolic or endocrine disorder or any other condition that, in the opinion of the Investigator, renders the subject a poor candidate for inclusion into the study.
Has known allergies to the IMP or any of its excipients.
Has previously received belapectin within 6 months of randomization.
Is an employee or family member of the Investigator or study center personnel.](streamdown:incomplete-link)

Name	Affiliation	Role
Khurram Jamil, M.D.	Galectin Therapeutics Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294	United States
Digestive Health Specialists

Label	URL
Hepatology Journal Article- Efficacy and safety of belapectin for the prevention of esophageal varices in patients with MASH cirrhosis: The randomized, placebo-controlled NAVIGATE trial	View source

ID	Title	Description
FG000	Placebo	Phase 2b: Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3:Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Placebo: intravenous
FG001	Belapectin 2 mg/kg Lean Body Mass (LBM)

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 9, 2024	May 4, 2026

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Proportion of Patients in the Belapectin Treatment Groups Who Develop New Esophageal Varices at 78 Weeks [18 Months] of Treatment Compared to Placebo

Proportion of patients in the belapectin treatment groups who develop new esophageal varices at 78 weeks [18 months] of treatment compared to placebo.

Stage 1 of NAVIGATE was analyzed as a stand-alone trial. Following FDA discussions, the Sponsor stopped the trial in January 2026, before Stage 2 (Phase 3) was initiated. All the results reported here are for Stage 1 (Phase 2b) 18-month time point.

Posted

Count of Participants

Participants

At 78 weeks [18 months]

ID	Title	Description
OG000	Placebo	Phase 2b: Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3:Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Placebo: intravenous
OG001	Belapectin 2 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 2 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous
OG002	Belapectin 4 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 4 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous

Units	Counts
Participants	OG000118 OG001119 OG002118

Title

Denominators

Categories

Title	Measurements
	OG00056 OG00145 OG00251

Secondary

Efficacy: Cumulative Incidence Rate of Patients in the Belapectin Treatment Groups, Compared to Placebo, Who Develop Varices (Esophageal or Gastric) Requiring Treatment

Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop varices (esophageal or gastric) requiring treatment.

Stage 1 of NAVIGATE was analyzed as a stand-alone trial. Study was terminated before Stage 2 was initiated. All the results reported here are for 18-month time point.

Posted

Count of Participants

Participants

Through study end, 78 weeks or 156 weeks

ID	Title	Description
OG000	Placebo	Phase 2b: Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3:Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Placebo: intravenous
OG001	Belapectin 2 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 2 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous
OG002	Belapectin 4 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 4 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous

Secondary

Efficacy: Cumulative Incidence Rate of Patients in the Belapectin Treatment Groups, Compared to Placebo, Who Develop Variceal Bleed Requiring Hospitalization

Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop variceal bleed requiring hospitalization.

Stage 1 of NAVIGATE was analyzed as a stand-alone trial. Study was terminated before Stage 2 was initiated. All the results reported here are for 18-month time point.

Posted

Count of Participants

Participants

Through study end, 78 weeks or 156 weeks

ID	Title	Description
OG000	Placebo	Phase 2b: Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3:Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Placebo: intravenous
OG001	Belapectin 2 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 2 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous
OG002	Belapectin 4 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 4 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous

Secondary

Efficacy: Cumulative Incidence Rate of Patients in the Belapectin Treatment Groups, Compared to Placebo, Who Develop Clinically Significant Ascites Requiring Hospitalization

Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop clinically significant ascites requiring hospitalization.

Stage 1 of NAVIGATE was analyzed as a stand-alone trial. Study was terminated before Stage 2 was initiated. All the results reported here are for 18-month time point.

Posted

Count of Participants

Participants

Through study end, 78 weeks or 156 weeks

ID	Title	Description
OG000	Placebo	Phase 2b: Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3:Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Placebo: intravenous
OG001	Belapectin 2 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 2 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous
OG002	Belapectin 4 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 4 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous

Secondary

Efficacy: Cumulative Incidence Rate of Patients in the Belapectin Treatment Groups, Compared to Placebo, Who Develop Spontaneous Bacterial Peritonitis

Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop spontaneous bacterial peritonitis.

Stage 1 of NAVIGATE was analyzed as a stand-alone trial. Study was terminated before Stage 2 was initiated. All the results reported here are for 18-month time point.

Posted

Count of Participants

Participants

Through study end, 78 weeks or 156 weeks

ID	Title	Description
OG000	Placebo	Phase 2b: Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3:Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Placebo: intravenous
OG001	Belapectin 2 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 2 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous
OG002	Belapectin 4 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 4 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous

Secondary

Efficacy: Cumulative Incidence Rate of Patients in the Belapectin Treatment Groups, Compared to Placebo, Who Develop Hepatic Encephalopathy (West Haven Score ≥2 and Requiring Hospitalization)

Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop hepatic encephalopathy (West Haven score ≥2 and requiring hospitalization).

Stage 1 of NAVIGATE was analyzed as a stand-alone trial. Study was terminated before Stage 2 was initiated. All the results reported here are for 18-month time point.

Posted

Count of Participants

Participants

Through study end, 78 weeks or 156 weeks

ID	Title	Description
OG000	Placebo	Phase 2b: Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3:Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Placebo: intravenous
OG001	Belapectin 2 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 2 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous
OG002	Belapectin 4 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 4 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous

Secondary

Efficacy: Cumulative Incidence Rate of Patients in the Belapectin Treatment Groups, Compared to Placebo, Who Develop Mortality (All-cause)

Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop mortality (all-cause).

Stage 1 of NAVIGATE was analyzed as a stand-alone trial. Study was terminated before Stage 2 was initiated. All the results reported here are for 18-month time point.

Posted

Count of Participants

Participants

Through study end, 78 weeks or 156 weeks

ID	Title	Description
OG000	Placebo	Phase 2b: Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3:Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Placebo: intravenous
OG001	Belapectin 2 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 2 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous
OG002	Belapectin 4 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 4 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous

Secondary

Efficacy: Cumulative Incidence Rate of Patients in the Belapectin Treatment Groups, Compared to Placebo, Who Develop Liver Transplant

Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop liver transplant.

Stage 1 of NAVIGATE was analyzed as a stand-alone trial. Study was terminated before Stage 2 was initiated. All the results reported here are for 18-month time point.

Posted

Count of Participants

Participants

Through study end, 78 weeks or 156 weeks

ID	Title	Description
OG000	Placebo	Phase 2b: Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3:Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Placebo: intravenous
OG001	Belapectin 2 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 2 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous
OG002	Belapectin 4 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 4 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous

Secondary

Efficacy: Cumulative Incidence Rate of Patients in the Belapectin Treatment Groups, Compared to Placebo, Who Develop Model for End-stage Liver Disease (MELD) Score ≥15

Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop model for end-stage liver disease (MELD) score ≥15.

Stage 1 of NAVIGATE was analyzed as a stand-alone trial. Study was terminated before Stage 2 was initiated. All the results reported here are for 18-month time point.

Posted

Count of Participants

Participants

Through study end, 78 weeks or 156 weeks

ID	Title	Description
OG000	Placebo	Phase 2b: Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3:Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Placebo: intravenous
OG001	Belapectin 2 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 2 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous
OG002	Belapectin 4 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 4 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous

Secondary

Efficacy: Cumulative Incidence Rate of Patients in the Belapectin Phase 3 Treatment Group Who Progress to Large Varices (Gastric or Esophageal) or Develop Red Wales Compared to Placebo.

Efficacy: Cumulative incidence rate of patients in the belapectin Phase 3 treatment group who progress to large varices (gastric or esophageal) or develop red wales compared to placebo.

Stage 1 of NAVIGATE was analyzed as a stand-alone trial. Study was terminated before Stage 2 was initiated. All the results reported here are for 18-month time point.

Posted

Count of Participants

Participants

Through study end, 78 weeks or 156 weeks

ID	Title	Description
OG000	Placebo	Phase 2b: Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3:Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Placebo: intravenous
OG001	Belapectin 2 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 2 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous
OG002	Belapectin 4 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 4 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous

Secondary

Efficacy: Event-free Survival by Time to First Cirrhosis Related Clinical Event, Progression to Large Varices or Red Wales

Number of participants who experienced first cirrhosis related clinical event, progression to large varices or red wales by week 78.

Stage 1 of NAVIGATE was analyzed as a stand-alone trial. Study was terminated before Stage 2 was initiated. All the results reported here are for 18-month time point.

Posted

Count of Participants

Participants

Through study end, 78 weeks or 156 weeks

ID	Title	Description
OG000	Placebo	Phase 2b: Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3:Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Placebo: intravenous
OG001	Belapectin 2 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 2 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous
OG002	Belapectin 4 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 4 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous

Secondary

Efficacy: Event-free Survival by Time to First Cirrhosis Related Clinical Event, Esophageal Variceal Hemorrhage Requiring Hospitalization

Number of participants who experienced first cirrhosis related clinical event, esophageal variceal hemorrhage requiring hospitalization by week 78.

Stage 1 of NAVIGATE was analyzed as a stand-alone trial. Study was terminated before Stage 2 was initiated. All the results reported here are for 18-month time point.

Posted

Count of Participants

Participants

Through study end, 78 weeks or 156 weeks

ID	Title	Description
OG000	Placebo	Phase 2b: Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3:Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Placebo: intravenous
OG001	Belapectin 2 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 2 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous
OG002	Belapectin 4 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 4 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous

Secondary

Efficacy: Event-free Survival by Time to First Cirrhosis Related Clinical Event, Clinically Significant Ascites Requiring Hospitalization

Number of participants who experienced first cirrhosis related clinical event, clinically significant ascites requiring hospitalization by week 78.

Stage 1 of NAVIGATE was analyzed as a stand-alone trial. Study was terminated before Stage 2 was initiated. All the results reported here are for 18-month time point.

Posted

Count of Participants

Participants

Through study end, 78 weeks or 156 weeks

ID	Title	Description
OG000	Placebo	Phase 2b: Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3:Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Placebo: intravenous
OG001	Belapectin 2 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 2 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous
OG002	Belapectin 4 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 4 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous

Secondary

Efficacy: Event-free Survival by Time to First Cirrhosis Related Clinical Event, Spontaneous Bacterial Peritonitis

Number of participants who experienced first cirrhosis related clinical event, spontaneous bacterial peritonitis by week 78.

Stage 1 of NAVIGATE was analyzed as a stand-alone trial. Study was terminated before Stage 2 was initiated. All the results reported here are for 18-month time point.

Posted

Count of Participants

Participants

Through study end, 78 weeks or 156 weeks

ID	Title	Description
OG000	Placebo	Phase 2b: Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3:Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Placebo: intravenous
OG001	Belapectin 2 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 2 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous
OG002	Belapectin 4 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 4 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous

Secondary

Efficacy: Event-free Survival by Time to First Cirrhosis Related Clinical Event, Overt Hepatic Encephalopathy (West Haven Score ≥2 and Requiring Hospitalization)

Number of participants who experienced first cirrhosis related clinical event, overt hepatic encephalopathy (West Haven score ≥2 and requiring hospitalization) by week 78.

Stage 1 of NAVIGATE was analyzed as a stand-alone trial. Study was terminated before Stage 2 was initiated. All the results reported here are for 18-month time point.

Posted

Count of Participants

Participants

Through study end, 78 weeks or 156 weeks

ID	Title	Description
OG000	Placebo	Phase 2b: Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3:Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Placebo: intravenous
OG001	Belapectin 2 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 2 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous
OG002	Belapectin 4 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 4 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous

Secondary

Efficacy: Event-free Survival by Time to First Cirrhosis Related Clinical Event, Child-Turcotte-Pugh (CTP) Score Increase of ≥2 Points (From Baseline)

Number of participants who experienced first cirrhosis related clinical event, Child-Turcotte-Pugh (CTP) score increase of ≥2 points (from baseline) by week 78.

Stage 1 of NAVIGATE was analyzed as a stand-alone trial. Study was terminated before Stage 2 was initiated. All the results reported here are for 18-month time point.

Posted

Count of Participants

Participants

Through study end, 78 weeks or 156 weeks

ID	Title	Description
OG000	Placebo	Phase 2b: Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3:Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Placebo: intravenous
OG001	Belapectin 2 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 2 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous
OG002	Belapectin 4 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 4 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous

Secondary

Efficacy: Event-free Survival by Time to First Cirrhosis Related Clinical Event, Model for End-stage Liver Disease (MELD) Score Increase to ≥15 as Measured on 2 Consecutive Occasions

Number of participants who experienced first cirrhosis related clinical event, model for end-stage liver disease (MELD) score increase to ≥15 as measured on 2 consecutive occasions by week 78.

Stage 1 of NAVIGATE was analyzed as a stand-alone trial. Study was terminated before Stage 2 was initiated. All the results reported here are for 18-month time point.

Posted

Count of Participants

Participants

Through study end, 78 weeks or 156 weeks

ID	Title	Description
OG000	Placebo	Phase 2b: Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3:Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Placebo: intravenous
OG001	Belapectin 2 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 2 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous
OG002	Belapectin 4 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 4 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous

Secondary

Efficacy: Event-free Survival by Time to First Cirrhosis Related Clinical Event, Liver Transplant

Number of participants who experienced first cirrhosis related clinical event, liver transplant by week 78.

Stage 1 of NAVIGATE was analyzed as a stand-alone trial. Study was terminated before Stage 2 was initiated. All the results reported here are for 18-month time point.

Posted

Count of Participants

Participants

Through study end, 78 weeks or 156 weeks

ID	Title	Description
OG000	Placebo	Phase 2b: Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3:Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Placebo: intravenous
OG001	Belapectin 2 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 2 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous
OG002	Belapectin 4 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 4 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous

Secondary

Efficacy: Event-free Survival by Time to First Cirrhosis Related Clinical Event, Liver-related Death

Number of participants who experienced first cirrhosis related clinical event, liver-related death by week 78.

Stage 1 of NAVIGATE was analyzed as a stand-alone trial. Study was terminated before Stage 2 was initiated. All the results reported here are for 18-month time point.

Posted

Count of Participants

Participants

Through study end, 78 weeks or 156 weeks

ID	Title	Description
OG000	Placebo	Phase 2b: Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3:Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Placebo: intravenous
OG001	Belapectin 2 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 2 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous
OG002	Belapectin 4 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 4 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous

Other Pre-specified

Exploratory Efficacy:Change in Liver Stiffness Measurement (LSM), Baseline-adjusted, as Determined by Vibration Controlled Transient Elastography (VCTE) (FibroScan) Exams During Phase 2b and Phase 3

Exploratory Efficacy: Change in liver stiffness measurement (LSM), baseline-adjusted, as determined by vibration controlled transient elastography (VCTE) (FibroScan) exams during Phase 2b and Phase 3

Subjects with all Phase 2b LSM assessments. Stage 1 of NAVIGATE was analyzed as a stand-alone trial. Study was terminated before Stage 2 was initiated. All the results reported here are for 18-month time point.

Posted

Mean

Standard Deviation

% change in kPa

Through study end, 78 weeks or 156 weeks

ID	Title	Description
OG000	Placebo	Phase 2b: Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3:Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Placebo: intravenous
OG001	Belapectin 2 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 2 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous
OG002	Belapectin 4 mg/kg Lean Body Mass (LBM)

Other Pre-specified

Safety: Incidence of Adverse Events

Safety: Incidence of adverse events.

Stage 1 of NAVIGATE was analyzed as a stand-alone trial. Study was terminated before Stage 2 was initiated. All the results reported here are for 18-month time point.

Posted

Count of Participants

Participants

Through study end, 78 weeks or 156 weeks

ID	Title	Description
OG000	Placebo	Phase 2b: Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3:Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Placebo: intravenous
OG001	Belapectin 2 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 2 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous
OG002	Belapectin 4 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 4 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous

Post-Hoc

>30% kPa Increase From Baseline

Worsening in liver stiffness measure, LSM (kPa), >30% kPa increase from baseline.

Subjects with all Phase 2b LSM assessments.

Posted

Count of Participants

Participants

78 Weeks

ID	Title	Description
OG000	Placebo	Phase 2b: Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3:Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Placebo: intravenous
OG001	Belapectin 2 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 2 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous
OG002	Belapectin 4 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 4 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous

Post-Hoc

>5 Point kPa Increase From Baseline

Worsening in liver stiffness measure, LSM (kPa), >5 point kPa increase from baseline.

Subjects with all Phase 2b LSM assessments.

Posted

Count of Participants

Participants

78 weeks

ID	Title	Description
OG000	Placebo	Phase 2b: Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3:Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Placebo: intravenous
OG001	Belapectin 2 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 2 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous
OG002	Belapectin 4 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 4 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous

Post-Hoc

Subjects With Composite Clinical Outcomes

Liver related composite clinical outcomes/MACE (major adverse cardiovascular events) at 78 weeks.

Per protocol population.

Posted

Count of Participants

Participants

78 weeks

ID	Title	Description
OG000	Placebo	Phase 2b: Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3:Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Placebo: intravenous
OG001	Belapectin 2 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 2 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous
OG002	Belapectin 4 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 4 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
COVID-19	Infections and infestations	Non-systematic Assessment	EG00032 affected118 at risk EG00136 affected119 at risk EG00237 affected120 at risk
Urinary Tract Infection	Infections and infestations	Non-systematic Assessment	EG00027 affected118 at risk EG00130 affected119 at risk EG00225 affected120 at risk
Nasopharyngitis	Infections and infestations	Non-systematic Assessment	EG00015 affected118 at risk EG00123 affected119 at risk EG00214 affected120 at risk
Upper respiratory tract infection	Infections and infestations	Non-systematic Assessment	EG00013 affected118 at risk EG00112 affected119 at risk EG00221 affected120 at risk
Influenza	Infections and infestations	Non-systematic Assessment	EG00014 affected118 at risk EG00110 affected119 at risk EG0029 affected120 at risk
Sinusitis	Infections and infestations	Non-systematic Assessment	EG00014 affected118 at risk EG0019 affected119 at risk EG00210 affected120 at risk
Bronchitis	Infections and infestations	Non-systematic Assessment	EG0009 affected118 at risk EG0019 affected119 at risk EG0025 affected120 at risk
Gastroenteritis	Infections and infestations	Non-systematic Assessment	EG0003 affected118 at risk EG00111 affected119 at risk EG0027 affected120 at risk
Diarrhoea	Gastrointestinal disorders	Non-systematic Assessment	EG00029 affected118 at risk EG00127 affected119 at risk EG00225 affected120 at risk
Nausea	Gastrointestinal disorders	Non-systematic Assessment	EG00023 affected118 at risk EG00117 affected119 at risk EG00217 affected120 at risk
Abdominal pain upper	Gastrointestinal disorders	Non-systematic Assessment	EG00011 affected118 at risk EG00111 affected119 at risk EG00215 affected120 at risk
Abdominal pain	Gastrointestinal disorders	Non-systematic Assessment	EG00014 affected118 at risk EG0017 affected119 at risk EG00212 affected120 at risk
Constipation	Gastrointestinal disorders	Non-systematic Assessment	EG00010 affected118 at risk EG00111 affected119 at risk EG00212 affected120 at risk
Varices oesophageal	Gastrointestinal disorders	Non-systematic Assessment	EG00011 affected118 at risk EG00110 affected119 at risk EG0027 affected120 at risk
Vomiting	Gastrointestinal disorders	Non-systematic Assessment	EG0009 affected118 at risk EG0018 affected119 at risk EG0028 affected120 at risk
Gastritis	Gastrointestinal disorders	Non-systematic Assessment	EG0009 affected118 at risk EG0018 affected119 at risk EG0026 affected120 at risk
Abdominal distension	Gastrointestinal disorders	Non-systematic Assessment	EG0007 affected118 at risk EG0013 affected119 at risk EG00210 affected120 at risk
Ascites	Gastrointestinal disorders	Non-systematic Assessment	EG0004 affected118 at risk EG0018 affected119 at risk EG0026 affected120 at risk
Fatigue	General disorders	Non-systematic Assessment	EG00019 affected118 at risk EG00121 affected119 at risk EG00218 affected120 at risk
Oedema peripheral	General disorders	Non-systematic Assessment	EG00015 affected118 at risk EG00110 affected119 at risk EG00216 affected120 at risk
Pyrexia	General disorders	Non-systematic Assessment	EG0005 affected118 at risk EG0014 affected119 at risk EG00210 affected120 at risk
Contusion	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0008 affected118 at risk EG0018 affected119 at risk EG00211 affected120 at risk
Fall	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0008 affected118 at risk EG0016 affected119 at risk EG0028 affected120 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG00020 affected118 at risk EG00124 affected119 at risk EG00224 affected120 at risk
Back pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG00013 affected118 at risk EG00112 affected119 at risk EG00219 affected120 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG00012 affected118 at risk EG00110 affected119 at risk EG0026 affected120 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0006 affected118 at risk EG00113 affected119 at risk EG0026 affected120 at risk
Headache	Nervous system disorders	Non-systematic Assessment	EG00017 affected118 at risk EG00113 affected119 at risk EG00221 affected120 at risk
Dizziness	Nervous system disorders	Non-systematic Assessment	EG00011 affected118 at risk EG00118 affected119 at risk EG00212 affected120 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG00017 affected118 at risk EG00114 affected119 at risk EG00214 affected120 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0008 affected118 at risk EG0019 affected119 at risk EG0024 affected120 at risk
Pruritus	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0009 affected118 at risk EG00115 affected119 at risk EG00212 affected120 at risk
Rash	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0007 affected118 at risk EG0016 affected119 at risk EG0026 affected120 at risk
Hypertension	Vascular disorders	Non-systematic Assessment	EG00011 affected118 at risk EG00110 affected119 at risk EG0029 affected120 at risk

ID	Term
D065626	Non-alcoholic Fatty Liver Disease
D005355	Fibrosis
D004932	Esophageal and Gastric Varices
D006975	Hypertension, Portal

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

ID	Title	Description
BG000	Placebo	Phase 2b: Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3:Placebo, administered intravenously (IV) every other week for 78 weeks (18 months)
BG001	Belapectin 2 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 2 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose
BG002	Belapectin 4 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 4 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Phase 2b: Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3:Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Placebo: intravenous	2	118	24	118	112	118
EG001	Belapectin 2 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 2 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous	5	119	29	119	116	119
EG002	Belapectin 4 mg/kg Lean Body Mass (LBM)	Phase 2b: Belapectin 4 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3: The patient will be switched to the optimal dose belapectin: intravenous	1	120	26	120	117	120

Term	Organ System	Assessment Type	Statistical Information
Coronary artery disease	Cardiac disorders	Non-systematic Assessment	EG0002 affected118 at risk EG0012 affected119 at risk EG0021 affected120 at risk
Other	Cardiac disorders	Non-systematic Assessment	EG0002 affected118 at risk EG0010 affected119 at risk EG0022 affected120 at risk
Oedema peripheral	General disorders	Non-systematic Assessment	EG0000 affected118 at risk EG0010 affected119 at risk EG0022 affected120 at risk
Other	Infections and infestations	Non-systematic Assessment	EG0004 affected118 at risk EG00110 affected119 at risk EG0027 affected120 at risk
Other	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0002 affected118 at risk EG0016 affected119 at risk EG0024 affected120 at risk
Other	Nervous system disorders	Non-systematic Assessment	EG0004 affected118 at risk EG0017 affected119 at risk EG0026 affected120 at risk
Other	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 affected118 at risk EG0010 affected119 at risk EG0021 affected120 at risk
Diplopmia	Eye disorders	Non-systematic Assessment	EG0001 affected118 at risk EG0010 affected119 at risk EG0020 affected120 at risk
Other	Hepatobiliary disorders	Non-systematic Assessment	EG0002 affected118 at risk EG0011 affected119 at risk EG0020 affected120 at risk
Other	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0003 affected118 at risk EG0013 affected119 at risk EG0022 affected120 at risk
Other	Metabolism and nutrition disorders	Non-systematic Assessment	EG0002 affected118 at risk EG0011 affected119 at risk EG0020 affected120 at risk
Other	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 affected118 at risk EG0011 affected119 at risk EG0021 affected120 at risk
Other	Psychiatric disorders	Non-systematic Assessment	EG0003 affected118 at risk EG0010 affected119 at risk EG0021 affected120 at risk
Other	Renal and urinary disorders	Non-systematic Assessment	EG0002 affected118 at risk EG0011 affected119 at risk EG0021 affected120 at risk
Other	Reproductive system and breast disorders	Non-systematic Assessment	EG0000 affected118 at risk EG0010 affected119 at risk EG0021 affected120 at risk
Other	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 affected118 at risk EG0014 affected119 at risk EG0022 affected120 at risk
Other	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 affected118 at risk EG0010 affected119 at risk EG0021 affected120 at risk
Other	Vascular disorders	Non-systematic Assessment	EG0002 affected118 at risk EG0011 affected119 at risk EG0021 affected120 at risk