Trial Outcomes & Findings for Phase 2a Study of HU6 in Subjects With Elevated Liver Fat and High BMI Volunteers (NCT NCT04874233)
NCT ID: NCT04874233
Last Updated: 2024-03-01
Results Overview
Percentage of Change from Baseline in Liver Fat Content as Assessed by MRI-PDFF at Day 61
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
Baseline and 61 days;
Results posted on
2024-03-01
Participant Flow
Study Start: April 19,2021, Completion: November 30,2021, Study Completion: December 15,2021 at one site
Participant milestones
| Measure |
Active Treatment: HU6 150 mg
Active Treatment: HU6 150 mg; HU6 is active study drug
|
Active Treatment: HU6 300 mg
Active Treatment: HU6 300 mg; HU6 is active study drug
|
Active Treatment: HU6 450 mg
Active Treatment: HU6 450 mg; HU6 is active study drug
|
Placebo Comparator Non-active Study Drug
Placebo Comparator Non-active study drug Placebo: Non-active study drug
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
19
|
20
|
|
Overall Study
COMPLETED
|
18
|
20
|
19
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 2a Study of HU6 in Subjects With Elevated Liver Fat and High BMI Volunteers
Baseline characteristics by cohort
| Measure |
Active: HU6 150mg
n=20 Participants
HU6 150mg is active Study Drug
|
Active: HU6 300mg
n=21 Participants
HU6 300mg is active study drug
|
Active: HU6 450mg
n=19 Participants
HU6 450 mg is active study drug
|
Placebo Comparator
n=20 Participants
Non-active study drug
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
46.2 years
STANDARD_DEVIATION 10.31 • n=5 Participants
|
47.1 years
STANDARD_DEVIATION 6.78 • n=7 Participants
|
46.7 years
STANDARD_DEVIATION 10.04 • n=5 Participants
|
50.7 years
STANDARD_DEVIATION 9.24 • n=4 Participants
|
47.7 years
STANDARD_DEVIATION 9.16 • n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
76 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
68 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Liver fat content, as assessed by MRI-PDFF
|
18.6 percentage of liver fat mass
STANDARD_DEVIATION 6.9 • n=5 Participants
|
18.0 percentage of liver fat mass
STANDARD_DEVIATION 8.2 • n=7 Participants
|
17.3 percentage of liver fat mass
STANDARD_DEVIATION 8.2 • n=5 Participants
|
15.9 percentage of liver fat mass
STANDARD_DEVIATION 5.9 • n=4 Participants
|
17.7 percentage of liver fat mass
STANDARD_DEVIATION 7.23 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and 61 days;Population: For HU6 450mg, 19 participants were randomized, but 18 was the number of participants analyzed. Percent change from baseline=(Value at Day 61/Value at baseline x 100%)
Percentage of Change from Baseline in Liver Fat Content as Assessed by MRI-PDFF at Day 61
Outcome measures
| Measure |
Active Treatment: HU6 150 mg
n=20 Participants
Active Treatment: HU6 150 mg; HU6 is active study drug
|
Active Treatment: HU6 300 mg;
n=21 Participants
Active Treatment: HU6 300 mg; HU6 is active study drug
|
Active Treatment: HU6 450 mg;
n=18 Participants
Active Treatment: HU6 450 mg; HU6 is active study drug
|
Placebo Comparator Non-active Study Drug
n=20 Participants
Placebo Comparator Non-active study drug; Placebo: Non-active study drug
|
|---|---|---|---|---|
|
Percentage of Change From Baseline in Liver Fat Content as Assessed by MRI-PDFF
|
-26.8 percentage of change
Standard Deviation 17.4
|
-35.6 percentage of change
Standard Deviation 13.8
|
-33.0 percentage of change
Standard Deviation 18.4
|
5.4 percentage of change
Standard Deviation 19.8
|
Adverse Events
Active: HU6 150mg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Active: HU6 300mg
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Active: HU6 450mg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo Comparator
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active: HU6 150mg
n=20 participants at risk
HU6 is active Study Drug
|
Active: HU6 300mg
n=21 participants at risk
HU6 is active study drug
|
Active: HU6 450mg
n=19 participants at risk
HU6 is active study drug
|
Placebo Comparator
n=20 participants at risk
Non-active study drug
|
|---|---|---|---|---|
|
Vascular disorders
Flushing
|
15.0%
3/20 • 61 days of dosing
|
38.1%
8/21 • 61 days of dosing
|
42.1%
8/19 • 61 days of dosing
|
10.0%
2/20 • 61 days of dosing
|
|
Vascular disorders
Hot Flush
|
5.0%
1/20 • 61 days of dosing
|
4.8%
1/21 • 61 days of dosing
|
0.00%
0/19 • 61 days of dosing
|
0.00%
0/20 • 61 days of dosing
|
|
Gastrointestinal disorders
Diarrhoea
|
15.0%
3/20 • 61 days of dosing
|
28.6%
6/21 • 61 days of dosing
|
31.6%
6/19 • 61 days of dosing
|
0.00%
0/20 • 61 days of dosing
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/20 • 61 days of dosing
|
4.8%
1/21 • 61 days of dosing
|
10.5%
2/19 • 61 days of dosing
|
0.00%
0/20 • 61 days of dosing
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • 61 days of dosing
|
0.00%
0/21 • 61 days of dosing
|
5.3%
1/19 • 61 days of dosing
|
5.0%
1/20 • 61 days of dosing
|
|
Cardiac disorders
Palpitations
|
10.0%
2/20 • 61 days of dosing
|
9.5%
2/21 • 61 days of dosing
|
15.8%
3/19 • 61 days of dosing
|
5.0%
1/20 • 61 days of dosing
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/20 • 61 days of dosing
|
9.5%
2/21 • 61 days of dosing
|
0.00%
0/19 • 61 days of dosing
|
0.00%
0/20 • 61 days of dosing
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20 • 61 days of dosing
|
4.8%
1/21 • 61 days of dosing
|
10.5%
2/19 • 61 days of dosing
|
0.00%
0/20 • 61 days of dosing
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • 61 days of dosing
|
9.5%
2/21 • 61 days of dosing
|
0.00%
0/19 • 61 days of dosing
|
15.0%
3/20 • 61 days of dosing
|
|
Nervous system disorders
Presyncope
|
0.00%
0/20 • 61 days of dosing
|
9.5%
2/21 • 61 days of dosing
|
5.3%
1/19 • 61 days of dosing
|
0.00%
0/20 • 61 days of dosing
|
|
Nervous system disorders
Somnolence
|
5.0%
1/20 • 61 days of dosing
|
4.8%
1/21 • 61 days of dosing
|
0.00%
0/19 • 61 days of dosing
|
5.0%
1/20 • 61 days of dosing
|
|
General disorders
Fatigue
|
5.0%
1/20 • 61 days of dosing
|
9.5%
2/21 • 61 days of dosing
|
5.3%
1/19 • 61 days of dosing
|
10.0%
2/20 • 61 days of dosing
|
|
General disorders
Pyrexia
|
0.00%
0/20 • 61 days of dosing
|
9.5%
2/21 • 61 days of dosing
|
5.3%
1/19 • 61 days of dosing
|
10.0%
2/20 • 61 days of dosing
|
|
General disorders
Vessel puncture site haemorrhage
|
0.00%
0/20 • 61 days of dosing
|
4.8%
1/21 • 61 days of dosing
|
5.3%
1/19 • 61 days of dosing
|
0.00%
0/20 • 61 days of dosing
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
2/20 • 61 days of dosing
|
4.8%
1/21 • 61 days of dosing
|
5.3%
1/19 • 61 days of dosing
|
0.00%
0/20 • 61 days of dosing
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
1/20 • 61 days of dosing
|
4.8%
1/21 • 61 days of dosing
|
5.3%
1/19 • 61 days of dosing
|
5.0%
1/20 • 61 days of dosing
|
|
Infections and infestations
Pharyngitis
|
10.0%
2/20 • 61 days of dosing
|
9.5%
2/21 • 61 days of dosing
|
0.00%
0/19 • 61 days of dosing
|
0.00%
0/20 • 61 days of dosing
|
|
Infections and infestations
Rhinitis
|
5.0%
1/20 • 61 days of dosing
|
0.00%
0/21 • 61 days of dosing
|
5.3%
1/19 • 61 days of dosing
|
0.00%
0/20 • 61 days of dosing
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
1/20 • 61 days of dosing
|
4.8%
1/21 • 61 days of dosing
|
5.3%
1/19 • 61 days of dosing
|
5.0%
1/20 • 61 days of dosing
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20 • 61 days of dosing
|
0.00%
0/21 • 61 days of dosing
|
5.3%
1/19 • 61 days of dosing
|
5.0%
1/20 • 61 days of dosing
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/20 • 61 days of dosing
|
0.00%
0/21 • 61 days of dosing
|
15.8%
3/19 • 61 days of dosing
|
5.0%
1/20 • 61 days of dosing
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/20 • 61 days of dosing
|
0.00%
0/21 • 61 days of dosing
|
5.3%
1/19 • 61 days of dosing
|
10.0%
2/20 • 61 days of dosing
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place