Trial Outcomes & Findings for A Study of Siliphos in Adults With Non-alcoholic Steatohepatitis (NASH) (NCT NCT00443079)

Results Overview

Side effect profile was collected at each study visit as tracked by study participants. Any new onset symptoms reported by study participants were recorded as side effects of treatment and analyzed according to whether they occurred while participants were treated with placebo or Siliphos. An increase in ALT value to greater than or equal to 2 x baseline value was also evaluated for possible drug induced liver injury.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

6 weeks

Results posted on

2021-03-24

Participant Flow

Adults with biopsy-proven NASH were recruited from outpatient hepatology clinics. Liver biopsy had to be within the previous year (no liver biopsies were done specifically to enroll in the study). ALT was elevated (normal ALT defined as 30U/L for men and 20U/L for women) and other types of chronic liver disease (viral hepatitis, alcohol, autoimmune) evaluated and excluded. Baseline kidney function was also normal (creatinine less than or equal to 1).

There were no participants who were excluded from study between informed consent/screening visit and study group allocation/randomization.

Participant milestones

Participant milestones
Measure	Siliphos/Placebo Subjects treated with study drug (IdB 1016 1 pill by mouth 3 times daily) for 6 weeks with 2 weeks of washout followed by placebo 1 pill by mouth three times daily for 6 weeks	Placebo/Siliphos Subjects treated with placebo 1 pill by mouth three times daily for 6 weeks with 2 weeks of washout followed by study drug (IdB 1016 1 pill by mouth 3 times daily) for 6 weeks
Overall Study STARTED	3	3
Overall Study COMPLETED	3	2
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Siliphos/Placebo Subjects treated with study drug (IdB 1016 1 pill by mouth 3 times daily) for 6 weeks with 2 weeks of washout followed by placebo 1 pill by mouth three times daily for 6 weeks	Placebo/Siliphos Subjects treated with placebo 1 pill by mouth three times daily for 6 weeks with 2 weeks of washout followed by study drug (IdB 1016 1 pill by mouth 3 times daily) for 6 weeks
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Siliphos/Placebo n=3 Participants Subjects treated with Siliphos (1 pill by mouth three times daily) for 6 weeks with 2 weeks of washout followed by placebo (1 pill by mouth three times daily) for 6 weeks	Placebo/Siliphos n=3 Participants Subjects treated with Placebo (1 pill by mouth three times daily) for 6 weeks with 2 weeks of washout followed by Siliphos (1 pill by mouth three times daily) for 6 weeks	Total n=6 Participants Total of all reporting groups
Age, Customized Age <50 years	6 participants n=3 Participants	6 participants n=3 Participants	12 participants n=6 Participants
Sex: Female, Male Female	2 Participants n=3 Participants	0 Participants n=3 Participants	2 Participants n=6 Participants
Sex: Female, Male Male	1 Participants n=3 Participants	3 Participants n=3 Participants	4 Participants n=6 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 6 weeks

Population: side effects and adverse events were gathered from study participants at each clinic visit

Side effect profile was collected at each study visit as tracked by study participants. Any new onset symptoms reported by study participants were recorded as side effects of treatment and analyzed according to whether they occurred while participants were treated with placebo or Siliphos. An increase in ALT value to greater than or equal to 2 x baseline value was also evaluated for possible drug induced liver injury.

Outcome measures

Outcome measures
Measure	Siliphos n=6 Participants All participants received both study drug and placebo. Adverse events were evaluated for all participants during the time period that they were receiving Siliphos. IdB 1016 (Siliphos): 1 pill 3 times daily x 6 weeks	Placebo n=6 Participants Adverse events were evaluated for all participants during the time period that they received placebo. Placebo: 1 pill 3 times daily x 6 weeks
Number of Study Participants With Adverse Events	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 weeks

Population: Number participants with a decrease in ALT value greater than or equal to 15 U/L from baseline to the end of the treatment era.

Change in ALT value from baseline to end of treatment arm during the time treated with Placebo in comparison to the time treated with Siliphos. Significant change in ALT was defined as a decrease by 15 or more units from baseline to end of treatment period.

Outcome measures

Outcome measures
Measure	Siliphos n=6 Participants All participants received both study drug and placebo. Adverse events were evaluated for all participants during the time period that they were receiving Siliphos. IdB 1016 (Siliphos): 1 pill 3 times daily x 6 weeks	Placebo n=6 Participants Adverse events were evaluated for all participants during the time period that they received placebo. Placebo: 1 pill 3 times daily x 6 weeks
Number of Participants With a Decrease in ALT Value Greater Than or Equal to 15 U/L From Baseline to the End of the Treatment Era	0 Participants	0 Participants

Adverse Events

Siliphos

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Heather Patton

UCSDMED

Phone: 619-543-2470

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place