Trial Outcomes & Findings for Phase 2a Study of HPG1860 in Subjects With NASH (NCT NCT05338034)
NCT ID: NCT05338034
Last Updated: 2026-05-28
Results Overview
Number of participants Treatment-emergent adverse events (TEAEs)
COMPLETED
PHASE2
89 participants
12 weeks
2026-05-28
Participant Flow
Approximately 80 eligible subjects will be randomized 1:1:1:1 to receive either HPG1860 3 mg (n = 20), or 5 mg (n = 20), or 8 mg (n = 20), or placebo (n = 20) for 12 weeks.
Participant milestones
| Measure |
Placebo
20 subjects will be treated with Placebo once daily at a similar time with or without food.
|
HPG1860 3 mg
20 subjects will be treated with HPG1860 3 mg once daily at a similar time with or without food.
|
HPG1860 5 mg
20 subjects will be treated with HPG1860 5 mg once daily at a similar time with or without food.
|
HPG1860 8 mg
20 subjects will be treated with HPG1860 5 mg once daily at a similar time with or without food.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
21
|
22
|
|
Overall Study
COMPLETED
|
18
|
19
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
3
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 2a Study of HPG1860 in Subjects With NASH
Baseline characteristics by cohort
| Measure |
Placebo
n=22 Participants
20 subjects will be treated with Placebo once daily at a similar time with or without food.
|
HPG1860 3 mg
n=22 Participants
20 subjects will be treated with HPG1860 3 mg once daily at a similar time with or without food.
|
HPG1860 5 mg
n=21 Participants
20 subjects will be treated with HPG1860 5 mg once daily at a similar time with or without food.
|
HPG1860 8 mg
n=22 Participants
20 subjects will be treated with HPG1860 5 mg once daily at a similar time with or without food.
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
52.4 year
STANDARD_DEVIATION 13.24 • n=51 Participants
|
54.7 year
STANDARD_DEVIATION 10.38 • n=14 Participants
|
51.3 year
STANDARD_DEVIATION 13.09 • n=65 Participants
|
50.6 year
STANDARD_DEVIATION 12.95 • n=24 Participants
|
52.2 year
STANDARD_DEVIATION 12.14 • n=107 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=51 Participants
|
14 Participants
n=14 Participants
|
7 Participants
n=65 Participants
|
6 Participants
n=24 Participants
|
42 Participants
n=107 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=51 Participants
|
8 Participants
n=14 Participants
|
14 Participants
n=65 Participants
|
16 Participants
n=24 Participants
|
45 Participants
n=107 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=107 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=51 Participants
|
1 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=107 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=107 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=51 Participants
|
4 Participants
n=14 Participants
|
2 Participants
n=65 Participants
|
1 Participants
n=24 Participants
|
7 Participants
n=107 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=51 Participants
|
17 Participants
n=14 Participants
|
18 Participants
n=65 Participants
|
19 Participants
n=24 Participants
|
76 Participants
n=107 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=107 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=107 Participants
|
|
liver fat content
|
20.105 liver fat content (%)
STANDARD_DEVIATION 4.8983 • n=51 Participants
|
19.744 liver fat content (%)
STANDARD_DEVIATION 6.3074 • n=14 Participants
|
14.828 liver fat content (%)
STANDARD_DEVIATION 4.4125 • n=65 Participants
|
19.291 liver fat content (%)
STANDARD_DEVIATION 7.5937 • n=24 Participants
|
18.002 liver fat content (%)
STANDARD_DEVIATION 6.5559 • n=107 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The Safety Population, used for all the safety summaries, was defined as all randomized subjects who received at least 1 dose of blinded IMP. Subjects were reported according to actual treatment received at the first dose.
Number of participants Treatment-emergent adverse events (TEAEs)
Outcome measures
| Measure |
Placebo
n=22 Participants
20 subjects will be treated with Placebo once daily at a similar time with or without food.
|
HPG1860 3 mg
n=22 Participants
20 subjects will be treated with HPG1860 3 mg once daily at a similar time with or without food.
|
HPG1860 5 mg
n=21 Participants
20 subjects will be treated with HPG1860 5 mg once daily at a similar time with or without food.
|
HPG1860 8 mg
n=22 Participants
20 subjects will be treated with HPG1860 5 mg once daily at a similar time with or without food.
|
|---|---|---|---|---|
|
Safety and Tolerability of Treatment
|
12 Participants
|
13 Participants
|
13 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 12 weekPopulation: The Intent-to-treat (ITT) Population, used for efficacy analyses, was defined as all randomized subjects. Subjects were reported according to randomized study treatment.
Change from baseline (CFB) in liver fat content (LFC) measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) at Week 12
Outcome measures
| Measure |
Placebo
n=22 Participants
20 subjects will be treated with Placebo once daily at a similar time with or without food.
|
HPG1860 3 mg
n=21 Participants
20 subjects will be treated with HPG1860 3 mg once daily at a similar time with or without food.
|
HPG1860 5 mg
n=22 Participants
20 subjects will be treated with HPG1860 5 mg once daily at a similar time with or without food.
|
HPG1860 8 mg
n=22 Participants
20 subjects will be treated with HPG1860 5 mg once daily at a similar time with or without food.
|
|---|---|---|---|---|
|
Liver Fat Content
|
-20.147 liver fat content(%)
Standard Deviation 18.5465
|
-7.078 liver fat content(%)
Standard Deviation 20.3823
|
-38.637 liver fat content(%)
Standard Deviation 20.0805
|
0.682 liver fat content(%)
Standard Deviation 20.3348
|
SECONDARY outcome
Timeframe: 4 week and 12 weekPopulation: The Intent-to-treat (ITT) Population, used for efficacy analyses, was defined as all randomized subjects. Subjects were reported according to randomized study treatment.
Percentage of subjects with ≥30% reduction in LFC from baseline measured by MRI-PDFF at Week 4 and Week 12
Outcome measures
| Measure |
Placebo
n=22 Participants
20 subjects will be treated with Placebo once daily at a similar time with or without food.
|
HPG1860 3 mg
n=21 Participants
20 subjects will be treated with HPG1860 3 mg once daily at a similar time with or without food.
|
HPG1860 5 mg
n=22 Participants
20 subjects will be treated with HPG1860 5 mg once daily at a similar time with or without food.
|
HPG1860 8 mg
n=22 Participants
20 subjects will be treated with HPG1860 5 mg once daily at a similar time with or without food.
|
|---|---|---|---|---|
|
Percentage of Subjects With ≥30% Reduction in LFC From Baseline
week 12
|
5 number of participants
|
1 number of participants
|
12 number of participants
|
1 number of participants
|
|
Percentage of Subjects With ≥30% Reduction in LFC From Baseline
week 4
|
3 number of participants
|
2 number of participants
|
7 number of participants
|
0 number of participants
|
SECONDARY outcome
Timeframe: 4 weekPopulation: The Intent-to-treat (ITT) Population, used for efficacy analyses, was defined as all randomized subjects. Subjects were reported according to randomized study treatment.
Change from baseline (CFB) in liver fat content (LFC) measured by MRI-PDFF at Week 4
Outcome measures
| Measure |
Placebo
n=22 Participants
20 subjects will be treated with Placebo once daily at a similar time with or without food.
|
HPG1860 3 mg
n=21 Participants
20 subjects will be treated with HPG1860 3 mg once daily at a similar time with or without food.
|
HPG1860 5 mg
n=22 Participants
20 subjects will be treated with HPG1860 5 mg once daily at a similar time with or without food.
|
HPG1860 8 mg
n=22 Participants
20 subjects will be treated with HPG1860 5 mg once daily at a similar time with or without food.
|
|---|---|---|---|---|
|
Change From Baseline (CFB) in Liver Fat Content (LFC) at 4 Week
|
-13.915 liver fat content(%)
Standard Deviation 13.8753
|
-10.295 liver fat content(%)
Standard Deviation 16.9240
|
-24.793 liver fat content(%)
Standard Deviation 17.0406
|
-3.174 liver fat content(%)
Standard Deviation 10.7469
|
Adverse Events
Placebo
HPG1860 3 mg
HPG1860 5 mg
HPG1860 8 mg
Serious adverse events
| Measure |
Placebo
n=22 participants at risk
20 subjects will be treated with Placebo once daily at a similar time with or without food.
|
HPG1860 3 mg
n=22 participants at risk
20 subjects will be treated with HPG1860 3 mg once daily at a similar time with or without food.
|
HPG1860 5 mg
n=21 participants at risk
20 subjects will be treated with HPG1860 5 mg once daily at a similar time with or without food.
|
HPG1860 8 mg
n=22 participants at risk
20 subjects will be treated with HPG1860 5 mg once daily at a similar time with or without food.
|
|---|---|---|---|---|
|
General disorders
Chest pain
|
0.00%
0/22 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/22 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/21 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
4.5%
1/22 • Number of events 1 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Hepatobiliary disorders
Hepatic enzyme increased
|
0.00%
0/22 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/22 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/21 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
4.5%
1/22 • Number of events 1 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
4.5%
1/22 • Number of events 1 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/22 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/21 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/22 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/22 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/22 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/21 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
4.5%
1/22 • Number of events 1 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
Other adverse events
| Measure |
Placebo
n=22 participants at risk
20 subjects will be treated with Placebo once daily at a similar time with or without food.
|
HPG1860 3 mg
n=22 participants at risk
20 subjects will be treated with HPG1860 3 mg once daily at a similar time with or without food.
|
HPG1860 5 mg
n=21 participants at risk
20 subjects will be treated with HPG1860 5 mg once daily at a similar time with or without food.
|
HPG1860 8 mg
n=22 participants at risk
20 subjects will be treated with HPG1860 5 mg once daily at a similar time with or without food.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.5%
1/22 • Number of events 1 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/22 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/21 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
18.2%
4/22 • Number of events 4 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/22 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/22 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
14.3%
3/21 • Number of events 3 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
13.6%
3/22 • Number of events 3 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Investigations
Hypertriglyceridaemia
|
0.00%
0/22 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/22 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
4.8%
1/21 • Number of events 1 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
13.6%
3/22 • Number of events 3 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
General disorders
Fatigue
|
0.00%
0/22 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
18.2%
4/22 • Number of events 4 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/21 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
4.5%
1/22 • Number of events 1 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Nervous system disorders
Headache
|
4.5%
1/22 • Number of events 1 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/22 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/21 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
13.6%
3/22 • Number of events 3 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/22 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
4.5%
1/22 • Number of events 1 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
4.8%
1/21 • Number of events 1 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
9.1%
2/22 • Number of events 3 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Infections and infestations
Urinary tract infection
|
4.5%
1/22 • Number of events 1 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
4.5%
1/22 • Number of events 1 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
9.5%
2/21 • Number of events 2 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
9.1%
2/22 • Number of events 3 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/22 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
4.5%
1/22 • Number of events 1 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
4.8%
1/21 • Number of events 1 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
9.1%
2/22 • Number of events 2 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Renal and urinary disorders
Proteinuria
|
9.1%
2/22 • Number of events 2 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/22 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
4.8%
1/21 • Number of events 1 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
9.1%
2/22 • Number of events 2 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/22 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
13.6%
3/22 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
9.5%
2/21 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
27.3%
6/22 • 12 weeks
Adverse event (AE) defined as follow:any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place