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)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

89 participants

Primary outcome timeframe

12 weeks

Results posted on

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

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

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 weeks

Population: 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

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 week

Population: 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

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 week

Population: 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

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 week

Population: 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

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

Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths

HPG1860 3 mg

Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths

HPG1860 5 mg

Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths

HPG1860 8 mg

Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths

Serious adverse events

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

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

Micheal Xu

Hepagene

Phone: +86 18516347399

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place