Trial Outcomes & Findings for Aramchol for HIV-associated Nonalcoholic Fatty Liver Disease and Lipodystrophy (NCT NCT02684591)

NCT ID: NCT02684591

Last Updated: 2020-07-17

Results Overview

To examine the efficacy of aramchol at 600 mg orally daily versus placebo in improving hepatic steatosis assessed by magnetic resonance imaging in patients with HIV-associated NAFLD

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 50 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2020-07-17

Participant Flow

Participant milestones

Measure	Aramchol 600 mg Orally Daily Total 600 mg Aramchol (200 mg/tablet and 400 mg/tablet) per day once a day orally for 12 weeks. Intervention: Aramchol Aramchol: Aramchol, a conjugate of Cholic acid and Arachidic acid, is a first in class member of a novel family of synthetic Fatty-Acid / Bile-Acid Conjugates (FABACs). FABACs are composed of endogenic compounds, orally administrated with potentially good safety and tolerability parameters	Placebo Placebo in the form of a tablet; Two bottles will be given to patient and they will take two pills, once a day orally for 12 weeks. Placebo: Placebo
Overall Study STARTED	25	25
Overall Study COMPLETED	24	22
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Aramchol for HIV-associated Nonalcoholic Fatty Liver Disease and Lipodystrophy

Baseline characteristics by cohort

Measure	Aramchol 600 mg Orally Daily n=25 Participants Total 600 mg Aramchol (200 mg/tablet and 400 mg/tablet) per day once a day orally for 12 weeks. Intervention: Aramchol Aramchol: Aramchol, a conjugate of Cholic acid and Arachidic acid, is a first in class member of a novel family of synthetic Fatty-Acid / Bile-Acid Conjugates (FABACs). FABACs are composed of endogenic compounds, orally administrated with potentially good safety and tolerability parameters	Placebo n=25 Participants Placebo in the form of a tablet; Two bottles will be given to patient and they will take two pills, once a day orally for 12 weeks. Placebo: Placebo	Total n=50 Participants Total of all reporting groups
Age, Continuous	46.6 years STANDARD_DEVIATION 11.4 • n=5 Participants	49.7 years STANDARD_DEVIATION 9.0 • n=7 Participants	48.2 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	24 Participants n=7 Participants	46 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	14 Participants n=5 Participants	19 Participants n=7 Participants	33 Participants n=5 Participants
MRI PDFF - Magnetic resonance imaging proton density fat fraction	16.2 percentage of fat n=5 Participants	12.1 percentage of fat n=7 Participants	12.8 percentage of fat n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

To examine the efficacy of aramchol at 600 mg orally daily versus placebo in improving hepatic steatosis assessed by magnetic resonance imaging in patients with HIV-associated NAFLD

Outcome measures

Measure	Aramchol 600 mg Orally Daily n=24 Participants Total 600 mg Aramchol (200 mg/tablet and 400 mg/tablet) per day once a day orally for 12 weeks. Intervention: Aramchol Aramchol: Aramchol, a conjugate of Cholic acid and Arachidic acid, is a first in class member of a novel family of synthetic Fatty-Acid / Bile-Acid Conjugates (FABACs). FABACs are composed of endogenic compounds, orally administrated with potentially good safety and tolerability parameters	Placebo n=22 Participants Placebo in the form of a tablet; Two bottles will be given to patient and they will take two pills, once a day orally for 12 weeks. Placebo: Placebo
Efficacy of Aramchol 600 mg vs. Placebo in Improving Hepatic Steatosis Assessed by Magnetic Resonance Imaging in Patients With HIV-associated NAFLD	13.7 percentage of fat Interval 1.5 to 26.3	11.1 percentage of fat Interval 2.7 to 24.3

SECONDARY outcome

Timeframe: 12 Weeks

To examine the efficacy of two doses of aramchol: 200 mg/tablet and 400 mg/tablet / day orally daily versus placebo in improving serum alanine aminotransferase (ALT) levels in patients with HIV-associated NAFLD

Outcome measures

Measure	Aramchol 600 mg Orally Daily n=24 Participants Total 600 mg Aramchol (200 mg/tablet and 400 mg/tablet) per day once a day orally for 12 weeks. Intervention: Aramchol Aramchol: Aramchol, a conjugate of Cholic acid and Arachidic acid, is a first in class member of a novel family of synthetic Fatty-Acid / Bile-Acid Conjugates (FABACs). FABACs are composed of endogenic compounds, orally administrated with potentially good safety and tolerability parameters	Placebo n=22 Participants Placebo in the form of a tablet; Two bottles will be given to patient and they will take two pills, once a day orally for 12 weeks. Placebo: Placebo
Serum Alanine Aminotransferase (ALT)	51 IU/L Interval 12.0 to 100.0	35 IU/L Interval 14.0 to 83.0

Adverse Events

Aramchol 600 mg Orally Daily

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Aramchol 600 mg Orally Daily n=25 participants at risk Total 600 mg Aramchol (200 mg/tablet and 400 mg/tablet) per day once a day orally for 12 weeks. Intervention: Aramchol Aramchol: Aramchol, a conjugate of Cholic acid and Arachidic acid, is a first in class member of a novel family of synthetic Fatty-Acid / Bile-Acid Conjugates (FABACs). FABACs are composed of endogenic compounds, orally administrated with potentially good safety and tolerability parameters	Placebo n=25 participants at risk Placebo in the form of a tablet; Two bottles will be given to patient and they will take two pills, once a day orally for 12 weeks. Placebo: Placebo
Gastrointestinal disorders Acid Reflux	0.00% 0/25 • 12 Weeks	4.0% 1/25 • Number of events 1 • 12 Weeks
Gastrointestinal disorders Diarrhea	0.00% 0/25 • 12 Weeks	4.0% 1/25 • Number of events 1 • 12 Weeks
Gastrointestinal disorders Nausea	4.0% 1/25 • Number of events 1 • 12 Weeks	0.00% 0/25 • 12 Weeks
Gastrointestinal disorders Abdominal Pain	4.0% 1/25 • Number of events 1 • 12 Weeks	0.00% 0/25 • 12 Weeks
Skin and subcutaneous tissue disorders Cellulitis	4.0% 1/25 • Number of events 1 • 12 Weeks	0.00% 0/25 • 12 Weeks
General disorders Fatigue	0.00% 0/25 • 12 Weeks	4.0% 1/25 • Number of events 1 • 12 Weeks
Nervous system disorders Dizziness	4.0% 1/25 • Number of events 1 • 12 Weeks	0.00% 0/25 • 12 Weeks

Additional Information

Rohit Loomba, MD, MHSc

UCSD

Phone: 858-246-2201

Email: roloomba@ucsd.edu

Results disclosure agreements

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