Trial Outcomes & Findings for Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis (NCT NCT04365868)
NCT ID: NCT04365868
Last Updated: 2026-06-30
Results Overview
Proportion of patients in the belapectin treatment groups who develop new esophageal varices at 78 weeks \[18 months\] of treatment compared to placebo.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
357 participants
Primary outcome timeframe
At 78 weeks [18 months]
Results posted on
2026-06-30
Participant Flow
Participants were randomized in a 1:1:1 ratio to one of the following treatment arms: Belapectin 2 mg/kg LBM, Belapectin 4 mg/kg LBM, Placebo. Randomization was stratified by type 2 diabetes. The trial incorporated a pre-planned seamless adaptive structure consisting of 2 stages: • Stage 1 (Phase 2b) • Stage 2 (Phase 3). Following FDA discussions, the Sponsor stopped the trial in January 2026, before Stage 2 was initiated. All the results reported here are for Stage 1 18-month time point.
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.
Participant milestones
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
118
|
119
|
120
|
|
Overall Study
COMPLETED
|
95
|
97
|
99
|
|
Overall Study
NOT COMPLETED
|
23
|
22
|
21
|
Reasons for withdrawal
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
7
|
5
|
8
|
|
Overall Study
Death
|
1
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
2
|
|
Overall Study
Protocol Noncompliance
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
14
|
12
|
8
|
Baseline Characteristics
Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis
Baseline characteristics by cohort
| Measure |
Placebo
n=118 Participants
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)
|
Belapectin 2 mg/kg Lean Body Mass (LBM)
n=119 Participants
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 4 mg/kg Lean Body Mass (LBM)
n=118 Participants
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
|
Total
n=355 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
9 Participants
n=6 Participants
|
|
Age, Continuous
|
60.4 Years
STANDARD_DEVIATION 8.50 • n=20 Participants
|
60.6 Years
STANDARD_DEVIATION 8.82 • n=20 Participants
|
59.0 Years
STANDARD_DEVIATION 9.14 • n=40 Participants
|
60 Years
STANDARD_DEVIATION 8.83 • n=6 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=20 Participants
|
75 Participants
n=20 Participants
|
83 Participants
n=40 Participants
|
230 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=20 Participants
|
44 Participants
n=20 Participants
|
35 Participants
n=40 Participants
|
125 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
6 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
15 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
3 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
White
|
104 Participants
n=20 Participants
|
107 Participants
n=20 Participants
|
111 Participants
n=40 Participants
|
322 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
6 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
80 Participants
n=20 Participants
|
79 Participants
n=20 Participants
|
79 Participants
n=40 Participants
|
238 Participants
n=6 Participants
|
|
Region of Enrollment
Mexico
|
10 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
32 Participants
n=6 Participants
|
|
Region of Enrollment
Israel
|
7 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
18 Participants
n=6 Participants
|
|
Region of Enrollment
Canada
|
4 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
14 Participants
n=6 Participants
|
|
Region of Enrollment
Germany
|
2 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
9 Participants
n=6 Participants
|
|
Region of Enrollment
Australia
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
7 Participants
n=6 Participants
|
|
Region of Enrollment
Chile
|
4 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
7 Participants
n=6 Participants
|
|
Region of Enrollment
Spain
|
3 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
7 Participants
n=6 Participants
|
|
Region of Enrollment
France
|
0 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
6 Participants
n=6 Participants
|
|
Region of Enrollment
Argentina
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
5 Participants
n=6 Participants
|
|
Region of Enrollment
Belgium
|
3 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
4 Participants
n=6 Participants
|
|
Region of Enrollment
United Kingdom
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
4 Participants
n=6 Participants
|
|
Region of Enrollment
Poland
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=6 Participants
|
|
Region of Enrollment
South Korea
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=6 Participants
|
|
Weight
|
94.2 kg
STANDARD_DEVIATION 21.68 • n=20 Participants
|
98.1 kg
STANDARD_DEVIATION 24.30 • n=20 Participants
|
94.6 kg
STANDARD_DEVIATION 20.95 • n=40 Participants
|
95.6 kg
STANDARD_DEVIATION 22.37 • n=6 Participants
|
|
Body Mass Index (BMI) kg/m2
|
33.82 kg/m2
STANDARD_DEVIATION 6.467 • n=20 Participants
|
34.88 kg/m2
STANDARD_DEVIATION 6.683 • n=20 Participants
|
34.53 kg/m2
STANDARD_DEVIATION 6.223 • n=40 Participants
|
34.41 kg/m2
STANDARD_DEVIATION 6.458 • n=6 Participants
|
|
NASH Cirrhosis Diagnosis
1A
|
48 Participants
n=20 Participants
|
48 Participants
n=20 Participants
|
54 Participants
n=40 Participants
|
150 Participants
n=6 Participants
|
|
NASH Cirrhosis Diagnosis
1B
|
11 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
33 Participants
n=6 Participants
|
|
NASH Cirrhosis Diagnosis
1C
|
17 Participants
n=20 Participants
|
15 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
46 Participants
n=6 Participants
|
|
NASH Cirrhosis Diagnosis
2A
|
2 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
7 Participants
n=6 Participants
|
|
Model End Stage Liver Disease Score (MELD)
|
7.6 MELD Score
STANDARD_DEVIATION 1.65 • n=20 Participants
|
7.9 MELD Score
STANDARD_DEVIATION 2.46 • n=20 Participants
|
7.5 MELD Score
STANDARD_DEVIATION 1.55 • n=40 Participants
|
7.7 MELD Score
STANDARD_DEVIATION 1.94 • n=6 Participants
|
|
NASH Cirrhosis Diagnosis
2B
|
38 Participants
n=20 Participants
|
38 Participants
n=20 Participants
|
37 Participants
n=40 Participants
|
113 Participants
n=6 Participants
|
|
NASH Cirrhosis Diagnosis
Missing
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
6 Participants
n=6 Participants
|
|
Hypertension
|
89 Participants
n=20 Participants
|
89 Participants
n=20 Participants
|
82 Participants
n=40 Participants
|
260 Participants
n=6 Participants
|
|
Liver Stiffness
|
24.22 kPa
STANDARD_DEVIATION 12.179 • n=20 Participants
|
24.63 kPa
STANDARD_DEVIATION 13.548 • n=20 Participants
|
25.67 kPa
STANDARD_DEVIATION 13.196 • n=40 Participants
|
24.84 kPa
STANDARD_DEVIATION 12.966 • n=6 Participants
|
|
Statin-Yes
|
49 Participants
n=20 Participants
|
55 Participants
n=20 Participants
|
47 Participants
n=40 Participants
|
151 Participants
n=6 Participants
|
|
GLP-1 Agonist-Yes
|
24 Participants
n=20 Participants
|
26 Participants
n=20 Participants
|
27 Participants
n=40 Participants
|
77 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: At 78 weeks [18 months]Population: 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.
Proportion of patients in the belapectin treatment groups who develop new esophageal varices at 78 weeks \[18 months\] of treatment compared to placebo.
Outcome measures
| Measure |
Placebo
n=118 Participants
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
|
Belapectin 2 mg/kg Lean Body Mass (LBM)
n=119 Participants
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
|
Belapectin 4 mg/kg Lean Body Mass (LBM)
n=118 Participants
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
|
|---|---|---|---|
|
Proportion of Patients in the Belapectin Treatment Groups Who Develop New Esophageal Varices at 78 Weeks [18 Months] of Treatment Compared to Placebo
|
56 Participants
|
45 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: Through study end, 78 weeks or 156 weeksPopulation: 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.
Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop varices (esophageal or gastric) requiring treatment.
Outcome measures
| Measure |
Placebo
n=118 Participants
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
|
Belapectin 2 mg/kg Lean Body Mass (LBM)
n=119 Participants
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
|
Belapectin 4 mg/kg Lean Body Mass (LBM)
n=118 Participants
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
|
|---|---|---|---|
|
Efficacy: Cumulative Incidence Rate of Patients in the Belapectin Treatment Groups, Compared to Placebo, Who Develop Varices (Esophageal or Gastric) Requiring Treatment
|
3 Participants
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Through study end, 78 weeks or 156 weeksPopulation: 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.
Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop variceal bleed requiring hospitalization.
Outcome measures
| Measure |
Placebo
n=118 Participants
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
|
Belapectin 2 mg/kg Lean Body Mass (LBM)
n=119 Participants
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
|
Belapectin 4 mg/kg Lean Body Mass (LBM)
n=118 Participants
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
|
|---|---|---|---|
|
Efficacy: Cumulative Incidence Rate of Patients in the Belapectin Treatment Groups, Compared to Placebo, Who Develop Variceal Bleed Requiring Hospitalization
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through study end, 78 weeks or 156 weeksPopulation: 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.
Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop clinically significant ascites requiring hospitalization.
Outcome measures
| Measure |
Placebo
n=118 Participants
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
|
Belapectin 2 mg/kg Lean Body Mass (LBM)
n=119 Participants
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
|
Belapectin 4 mg/kg Lean Body Mass (LBM)
n=118 Participants
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
|
|---|---|---|---|
|
Efficacy: Cumulative Incidence Rate of Patients in the Belapectin Treatment Groups, Compared to Placebo, Who Develop Clinically Significant Ascites Requiring Hospitalization
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through study end, 78 weeks or 156 weeksPopulation: 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.
Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop spontaneous bacterial peritonitis.
Outcome measures
| Measure |
Placebo
n=118 Participants
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
|
Belapectin 2 mg/kg Lean Body Mass (LBM)
n=119 Participants
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
|
Belapectin 4 mg/kg Lean Body Mass (LBM)
n=118 Participants
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
|
|---|---|---|---|
|
Efficacy: Cumulative Incidence Rate of Patients in the Belapectin Treatment Groups, Compared to Placebo, Who Develop Spontaneous Bacterial Peritonitis
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through study end, 78 weeks or 156 weeksPopulation: 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.
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).
Outcome measures
| Measure |
Placebo
n=118 Participants
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
|
Belapectin 2 mg/kg Lean Body Mass (LBM)
n=119 Participants
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
|
Belapectin 4 mg/kg Lean Body Mass (LBM)
n=118 Participants
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
|
|---|---|---|---|
|
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)
|
2 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Through study end, 78 weeks or 156 weeksPopulation: 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.
Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop mortality (all-cause).
Outcome measures
| Measure |
Placebo
n=118 Participants
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
|
Belapectin 2 mg/kg Lean Body Mass (LBM)
n=119 Participants
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
|
Belapectin 4 mg/kg Lean Body Mass (LBM)
n=118 Participants
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
|
|---|---|---|---|
|
Efficacy: Cumulative Incidence Rate of Patients in the Belapectin Treatment Groups, Compared to Placebo, Who Develop Mortality (All-cause)
|
1 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Through study end, 78 weeks or 156 weeksPopulation: 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.
Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop liver transplant.
Outcome measures
| Measure |
Placebo
n=118 Participants
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
|
Belapectin 2 mg/kg Lean Body Mass (LBM)
n=119 Participants
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
|
Belapectin 4 mg/kg Lean Body Mass (LBM)
n=118 Participants
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
|
|---|---|---|---|
|
Efficacy: Cumulative Incidence Rate of Patients in the Belapectin Treatment Groups, Compared to Placebo, Who Develop Liver Transplant
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through study end, 78 weeks or 156 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=118 Participants
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
|
Belapectin 2 mg/kg Lean Body Mass (LBM)
n=119 Participants
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
|
Belapectin 4 mg/kg Lean Body Mass (LBM)
n=118 Participants
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
|
|---|---|---|---|
|
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
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Through study end, 78 weeks or 156 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=118 Participants
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
|
Belapectin 2 mg/kg Lean Body Mass (LBM)
n=119 Participants
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
|
Belapectin 4 mg/kg Lean Body Mass (LBM)
n=118 Participants
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
|
|---|---|---|---|
|
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.
|
2 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through study end, 78 weeks or 156 weeksPopulation: 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.
Number of participants who experienced first cirrhosis related clinical event, progression to large varices or red wales by week 78.
Outcome measures
| Measure |
Placebo
n=118 Participants
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
|
Belapectin 2 mg/kg Lean Body Mass (LBM)
n=119 Participants
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
|
Belapectin 4 mg/kg Lean Body Mass (LBM)
n=118 Participants
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
|
|---|---|---|---|
|
Efficacy: Event-free Survival by Time to First Cirrhosis Related Clinical Event, Progression to Large Varices or Red Wales
|
2 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through study end, 78 weeks or 156 weeksPopulation: 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.
Number of participants who experienced first cirrhosis related clinical event, esophageal variceal hemorrhage requiring hospitalization by week 78.
Outcome measures
| Measure |
Placebo
n=118 Participants
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
|
Belapectin 2 mg/kg Lean Body Mass (LBM)
n=119 Participants
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
|
Belapectin 4 mg/kg Lean Body Mass (LBM)
n=118 Participants
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
|
|---|---|---|---|
|
Efficacy: Event-free Survival by Time to First Cirrhosis Related Clinical Event, Esophageal Variceal Hemorrhage Requiring Hospitalization
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through study end, 78 weeks or 156 weeksPopulation: 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.
Number of participants who experienced first cirrhosis related clinical event, clinically significant ascites requiring hospitalization by week 78.
Outcome measures
| Measure |
Placebo
n=118 Participants
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
|
Belapectin 2 mg/kg Lean Body Mass (LBM)
n=119 Participants
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
|
Belapectin 4 mg/kg Lean Body Mass (LBM)
n=118 Participants
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
|
|---|---|---|---|
|
Efficacy: Event-free Survival by Time to First Cirrhosis Related Clinical Event, Clinically Significant Ascites Requiring Hospitalization
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through study end, 78 weeks or 156 weeksPopulation: 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.
Number of participants who experienced first cirrhosis related clinical event, spontaneous bacterial peritonitis by week 78.
Outcome measures
| Measure |
Placebo
n=118 Participants
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
|
Belapectin 2 mg/kg Lean Body Mass (LBM)
n=119 Participants
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
|
Belapectin 4 mg/kg Lean Body Mass (LBM)
n=118 Participants
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
|
|---|---|---|---|
|
Efficacy: Event-free Survival by Time to First Cirrhosis Related Clinical Event, Spontaneous Bacterial Peritonitis
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through study end, 78 weeks or 156 weeksPopulation: 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.
Number of participants who experienced first cirrhosis related clinical event, overt hepatic encephalopathy (West Haven score ≥2 and requiring hospitalization) by week 78.
Outcome measures
| Measure |
Placebo
n=118 Participants
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
|
Belapectin 2 mg/kg Lean Body Mass (LBM)
n=119 Participants
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
|
Belapectin 4 mg/kg Lean Body Mass (LBM)
n=118 Participants
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
|
|---|---|---|---|
|
Efficacy: Event-free Survival by Time to First Cirrhosis Related Clinical Event, Overt Hepatic Encephalopathy (West Haven Score ≥2 and Requiring Hospitalization)
|
2 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Through study end, 78 weeks or 156 weeksPopulation: 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.
Number of participants who experienced first cirrhosis related clinical event, Child-Turcotte-Pugh (CTP) score increase of ≥2 points (from baseline) by week 78.
Outcome measures
| Measure |
Placebo
n=118 Participants
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
|
Belapectin 2 mg/kg Lean Body Mass (LBM)
n=119 Participants
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
|
Belapectin 4 mg/kg Lean Body Mass (LBM)
n=118 Participants
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
|
|---|---|---|---|
|
Efficacy: Event-free Survival by Time to First Cirrhosis Related Clinical Event, Child-Turcotte-Pugh (CTP) Score Increase of ≥2 Points (From Baseline)
|
1 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Through study end, 78 weeks or 156 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=118 Participants
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
|
Belapectin 2 mg/kg Lean Body Mass (LBM)
n=119 Participants
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
|
Belapectin 4 mg/kg Lean Body Mass (LBM)
n=118 Participants
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
|
|---|---|---|---|
|
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
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Through study end, 78 weeks or 156 weeksPopulation: 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.
Number of participants who experienced first cirrhosis related clinical event, liver transplant by week 78.
Outcome measures
| Measure |
Placebo
n=118 Participants
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
|
Belapectin 2 mg/kg Lean Body Mass (LBM)
n=119 Participants
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
|
Belapectin 4 mg/kg Lean Body Mass (LBM)
n=118 Participants
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
|
|---|---|---|---|
|
Efficacy: Event-free Survival by Time to First Cirrhosis Related Clinical Event, Liver Transplant
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through study end, 78 weeks or 156 weeksPopulation: 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.
Number of participants who experienced first cirrhosis related clinical event, liver-related death by week 78.
Outcome measures
| Measure |
Placebo
n=118 Participants
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
|
Belapectin 2 mg/kg Lean Body Mass (LBM)
n=119 Participants
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
|
Belapectin 4 mg/kg Lean Body Mass (LBM)
n=118 Participants
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
|
|---|---|---|---|
|
Efficacy: Event-free Survival by Time to First Cirrhosis Related Clinical Event, Liver-related Death
|
0 Participants
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study end, 78 weeks or 156 weeksPopulation: 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.
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
Outcome measures
| Measure |
Placebo
n=76 Participants
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
|
Belapectin 2 mg/kg Lean Body Mass (LBM)
n=81 Participants
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
|
Belapectin 4 mg/kg Lean Body Mass (LBM)
n=77 Participants
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
|
|---|---|---|---|
|
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
|
1.7 % change in kPa
Standard Deviation 46.78
|
-8.4 % change in kPa
Standard Deviation 38.33
|
-5.0 % change in kPa
Standard Deviation 38.05
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study end, 78 weeks or 156 weeksPopulation: 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.
Safety: Incidence of adverse events.
Outcome measures
| Measure |
Placebo
n=118 Participants
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
|
Belapectin 2 mg/kg Lean Body Mass (LBM)
n=119 Participants
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
|
Belapectin 4 mg/kg Lean Body Mass (LBM)
n=120 Participants
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
|
|---|---|---|---|
|
Safety: Incidence of Adverse Events
|
112 Participants
|
116 Participants
|
117 Participants
|
POST_HOC outcome
Timeframe: 78 WeeksPopulation: Subjects with all Phase 2b LSM assessments.
Worsening in liver stiffness measure, LSM (kPa), \>30% kPa increase from baseline.
Outcome measures
| Measure |
Placebo
n=76 Participants
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
|
Belapectin 2 mg/kg Lean Body Mass (LBM)
n=81 Participants
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
|
Belapectin 4 mg/kg Lean Body Mass (LBM)
n=77 Participants
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
|
|---|---|---|---|
|
>30% kPa Increase From Baseline
|
17 Participants
|
8 Participants
|
14 Participants
|
POST_HOC outcome
Timeframe: 78 weeksPopulation: Subjects with all Phase 2b LSM assessments.
Worsening in liver stiffness measure, LSM (kPa), \>5 point kPa increase from baseline.
Outcome measures
| Measure |
Placebo
n=76 Participants
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
|
Belapectin 2 mg/kg Lean Body Mass (LBM)
n=81 Participants
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
|
Belapectin 4 mg/kg Lean Body Mass (LBM)
n=77 Participants
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
|
|---|---|---|---|
|
>5 Point kPa Increase From Baseline
|
17 Participants
|
10 Participants
|
14 Participants
|
POST_HOC outcome
Timeframe: 78 weeksPopulation: Per protocol population.
Liver related composite clinical outcomes/MACE (major adverse cardiovascular events) at 78 weeks.
Outcome measures
| Measure |
Placebo
n=4 Participants
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
|
Belapectin 2 mg/kg Lean Body Mass (LBM)
n=3 Participants
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
|
Belapectin 4 mg/kg Lean Body Mass (LBM)
n=7 Participants
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
|
|---|---|---|---|
|
Subjects With Composite Clinical Outcomes
Varices (Esophageal or Gastric) Requiring Treatment
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Subjects With Composite Clinical Outcomes
Variceal Bleed Requiring Hospitalization
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Subjects With Composite Clinical Outcomes
Clinically Significant Ascites Requiring Hospitalization
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Subjects With Composite Clinical Outcomes
Overt Hepatic Encephalopathy (West Haven Score >=2 and Requiring Hospitalization)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Subjects With Composite Clinical Outcomes
Liver Transplant
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Subjects With Composite Clinical Outcomes
Model End Stage Liver Disease (MELD) Score >=15
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Subjects With Composite Clinical Outcomes
MI or Hospitalization for Unstable Angina
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Subjects With Composite Clinical Outcomes
Stroke or Transient Ischemic Attack
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Subjects With Composite Clinical Outcomes
Spontaneous Bacterial Peritonitis
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 24 serious events
Other events: 112 other events
Deaths: 2 deaths
Belapectin 2 mg/kg Lean Body Mass (LBM)
Serious events: 29 serious events
Other events: 116 other events
Deaths: 5 deaths
Belapectin 4 mg/kg Lean Body Mass (LBM)
Serious events: 26 serious events
Other events: 117 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo
n=118 participants at risk
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
|
Belapectin 2 mg/kg Lean Body Mass (LBM)
n=119 participants at risk
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
|
Belapectin 4 mg/kg Lean Body Mass (LBM)
n=120 participants at risk
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
|
|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
1.7%
2/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
1.7%
2/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
0.83%
1/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Cardiac disorders
Other
|
1.7%
2/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
0.00%
0/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
1.7%
2/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
General disorders
Oedema peripheral
|
0.00%
0/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
0.00%
0/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
1.7%
2/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Infections and infestations
Other
|
3.4%
4/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
8.4%
10/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
5.8%
7/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other
|
1.7%
2/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
5.0%
6/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
3.3%
4/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Nervous system disorders
Other
|
3.4%
4/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
5.9%
7/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
5.0%
6/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Blood and lymphatic system disorders
Other
|
0.85%
1/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
0.00%
0/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
0.83%
1/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Eye disorders
Diplopmia
|
0.85%
1/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
0.00%
0/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
0.00%
0/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Hepatobiliary disorders
Other
|
1.7%
2/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
0.84%
1/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
0.00%
0/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Injury, poisoning and procedural complications
Other
|
2.5%
3/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
2.5%
3/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
1.7%
2/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Metabolism and nutrition disorders
Other
|
1.7%
2/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
0.84%
1/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
0.00%
0/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Musculoskeletal and connective tissue disorders
Other
|
0.85%
1/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
0.84%
1/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
0.83%
1/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Psychiatric disorders
Other
|
2.5%
3/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
0.00%
0/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
0.83%
1/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Renal and urinary disorders
Other
|
1.7%
2/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
0.84%
1/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
0.83%
1/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Reproductive system and breast disorders
Other
|
0.00%
0/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
0.00%
0/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
0.83%
1/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Respiratory, thoracic and mediastinal disorders
Other
|
1.7%
2/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
3.4%
4/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
1.7%
2/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Skin and subcutaneous tissue disorders
Other
|
0.85%
1/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
0.00%
0/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
0.83%
1/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Vascular disorders
Other
|
1.7%
2/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
0.84%
1/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
0.83%
1/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
Other adverse events
| Measure |
Placebo
n=118 participants at risk
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
|
Belapectin 2 mg/kg Lean Body Mass (LBM)
n=119 participants at risk
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
|
Belapectin 4 mg/kg Lean Body Mass (LBM)
n=120 participants at risk
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
|
|---|---|---|---|
|
Infections and infestations
COVID-19
|
27.1%
32/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
30.3%
36/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
30.8%
37/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Infections and infestations
Urinary Tract Infection
|
22.9%
27/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
25.2%
30/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
20.8%
25/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Infections and infestations
Nasopharyngitis
|
12.7%
15/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
19.3%
23/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
11.7%
14/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.0%
13/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
10.1%
12/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
17.5%
21/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Infections and infestations
Influenza
|
11.9%
14/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
8.4%
10/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
7.5%
9/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Infections and infestations
Sinusitis
|
11.9%
14/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
7.6%
9/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
8.3%
10/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Infections and infestations
Bronchitis
|
7.6%
9/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
7.6%
9/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
4.2%
5/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Infections and infestations
Gastroenteritis
|
2.5%
3/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
9.2%
11/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
5.8%
7/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
24.6%
29/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
22.7%
27/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
20.8%
25/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Gastrointestinal disorders
Nausea
|
19.5%
23/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
14.3%
17/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
14.2%
17/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.3%
11/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
9.2%
11/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
12.5%
15/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.9%
14/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
5.9%
7/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
10.0%
12/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Gastrointestinal disorders
Constipation
|
8.5%
10/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
9.2%
11/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
10.0%
12/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Gastrointestinal disorders
Varices oesophageal
|
9.3%
11/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
8.4%
10/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
5.8%
7/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Gastrointestinal disorders
Vomiting
|
7.6%
9/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
6.7%
8/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
6.7%
8/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Gastrointestinal disorders
Gastritis
|
7.6%
9/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
6.7%
8/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
5.0%
6/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.9%
7/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
2.5%
3/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
8.3%
10/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Gastrointestinal disorders
Ascites
|
3.4%
4/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
6.7%
8/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
5.0%
6/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
General disorders
Fatigue
|
16.1%
19/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
17.6%
21/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
15.0%
18/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
General disorders
Oedema peripheral
|
12.7%
15/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
8.4%
10/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
13.3%
16/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
General disorders
Pyrexia
|
4.2%
5/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
3.4%
4/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
8.3%
10/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.8%
8/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
6.7%
8/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
9.2%
11/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Injury, poisoning and procedural complications
Fall
|
6.8%
8/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
5.0%
6/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
6.7%
8/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.9%
20/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
20.2%
24/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
20.0%
24/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.0%
13/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
10.1%
12/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
15.8%
19/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.2%
12/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
8.4%
10/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
5.0%
6/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.1%
6/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
10.9%
13/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
5.0%
6/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Nervous system disorders
Headache
|
14.4%
17/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
10.9%
13/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
17.5%
21/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Nervous system disorders
Dizziness
|
9.3%
11/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
15.1%
18/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
10.0%
12/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.4%
17/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
11.8%
14/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
11.7%
14/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.8%
8/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
7.6%
9/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
3.3%
4/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.6%
9/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
12.6%
15/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
10.0%
12/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
7/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
5.0%
6/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
5.0%
6/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
|
Vascular disorders
Hypertension
|
9.3%
11/118 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
8.4%
10/119 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
|
7.5%
9/120 • Time of informed consent through 30 days after the last dose of study drug. 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.
All AEs occurring after first exposure to Trial Drug were classified as treatment-emergent adverse events (TEAEs). 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.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI cannot publish results without prior sponsor approval.
- Publication restrictions are in place
Restriction type: OTHER