Study of the Safety and Tolerability of AXA1125 and AXA1957 in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
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| ClinicalTrials.gov Identifier: NCT04073368 |
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Recruitment Status :
Completed
First Posted : August 29, 2019
Results First Posted : July 2, 2021
Last Update Posted : July 6, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| NAFLD | Dietary Supplement: AXA1957 Dietary Supplement: AXA1125 Dietary Supplement: Placebo | Not Applicable |
This was a 16-week, single-blind, randomized, placebo-controlled food study of the safety and tolerability of AXA1125 and AXA1957 in subjects with NAFLD.
Subjects signed an informed consent form and were screened for eligibility, per the inclusion and exclusion criteria below, up to 6 weeks before the start of the administration period. Subjects were randomized as soon as eligibility was confirmed.
Eligible subjects were randomized in a 2:2:2:1 ratio to receive either AXA1125 24 g twice daily (BID), AXA1957 20.3 g BID, AXA1957 13.5 g BID, or placebo 24 g BID. Randomization occurred via an interactive web response system after eligibility was confirmed and approximately 3 to 5 days prior to the Day 1 visit. Assigned study food product (AXA1125, AXA1957, or placebo) were shipped to the study site upon randomization of each subject.
Once randomization had occurred, subjects presented to the study site on Day 1 (Baseline/Visit 2) for their baseline assessments per the schedule of events. Study Day 1 was the beginning of the 16-week administration period.
Subjects returned to the study site at Week 1 (Visit 3), Week 2 (Visit 4), Week 4 (Visit 5), Week 8 (Visit 6), Week 12 (Visit 7), and Week 16 (Visit 8) to receive their study food product and/or to return any unused study food product, provide blood samples for biomarker and other laboratory testing, undergo liver imaging, and complete other study safety assessments per the schedule of events.
The Safety Follow-up Visit, which occurred approximately 2 weeks after the last visit in the administration period (ie, after the Week 16 visit or at the time of early termination), was the End of Study Visit (Visit 9).
There were 9 study visits in total, including the Screening and Follow-up Visits.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 112 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Basic Science |
| Official Title: | A 16-Week, Single-Blind Randomized, Placebo- Controlled Food Study of the Safety and Tolerability of AXA1125 and AXA1957 in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD) |
| Actual Study Start Date : | December 3, 2018 |
| Actual Primary Completion Date : | March 31, 2020 |
| Actual Study Completion Date : | September 3, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: AXA1957 high dose
AXA1957 20.3g
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Dietary Supplement: AXA1957
Amino acids, food study |
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Active Comparator: AXA1957 low dose
AXA1957 13.5g
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Dietary Supplement: AXA1957
Amino acids, food study |
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Active Comparator: AXA1125
AXA1125 24g
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Dietary Supplement: AXA1125
Amino acids, food study |
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Placebo Comparator: Placebo
Placebo 24g
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Dietary Supplement: Placebo
Amino acids, food study |
- Number of Subjects With Incidence of Study Product Emergent Adverse Events (AEs) and Any Serious Adverse Events (SAEs) [ Time Frame: Baseline to week 16 ]Subjects received AXA1125 at 24 g twice daily ( BID), AXA1957 at 20.3 g BID or 13.5 g BID with Product related AEs and any SAEs up to 16 weeks
- Percent Change in Liver Fat as Assessed by MRI- Proton Density Fat Fraction (PDFF) [ Time Frame: Baseline to week 16 ]Relative Changes From Baseline in MRI-PDFF at Week 16 in Overall Subjects (Safety Analysis Population)
- Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) [ Time Frame: Baseline to week 16 ]Absolute Changes From Baseline in HOMA-IR at Week 16 in Overall Subjects (Safety Analysis Population)
- Change in Glucose Homeostasis [ Time Frame: Baseline to week 16 ]Absolute Changes From Baseline in HbA1c at Week 16 in Subjects with Diabetes (Safety Analysis Population)
- Relative Change in Alanine Aminotransferase (ALT) [ Time Frame: Baseline to week 16 ]Relative Changes From Baseline in ALT at Week 16 in Overall Subjects (Safety Analysis Population)
- Change in Aspartate Aminotransferase (AST) [ Time Frame: Baseline to Week 16 ]Relative Changes From Baseline in AST at Week 16 in Overall Subjects (Safety Analysis Population)
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Willing to participate in the study and provide written informed consent.
- Male and female adults aged > 18 years.
- Subjects must not have participated in any diet/lifestyle intervention or observational studies, or engaged in any body weight altering regimens that resulted in body weight fluctuations (i.e. body weight loss or gain by 5%) in the preceding 3 months prior to Screening.
- A screening MRI consistent with liver inflammation and fibrosis.
Key Exclusion Criteria:
- Current or history of significant alcohol consumption.
- History or presence of liver disease (other than NAFLD/NASH).
- History or presence of cirrhosis and/or history or presence of hepatic decompensation.
- Any diabetes other than Type 2.
- Other poorly controlled medical condition (for example, uncontrolled hypertension with a systolic blood pressure > 100 mmHg).
- Known sensitivity and/or history of clinically significant food intolerance/allergies to proteins (including whey, soy, casein, amino acids, etc.).
- Unable or unwilling to adhere to contraception requirements.
- Any contraindications to a MRI scan.
- Any other condition that, in the opinion of the Investigator, renders the subject at risk for compliance, compromises the well-being of the subject, or hinders study completion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04073368
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| Principal Investigator: | Stephen Harrison, MD | Pinnacle Clinical Research |
Documents provided by Axcella Health, Inc:
| Responsible Party: | Axcella Health, Inc |
| ClinicalTrials.gov Identifier: | NCT04073368 |
| Other Study ID Numbers: |
AXA1125-003 |
| First Posted: | August 29, 2019 Key Record Dates |
| Results First Posted: | July 2, 2021 |
| Last Update Posted: | July 6, 2021 |
| Last Verified: | June 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Liver Diseases Fatty Liver Non-alcoholic Fatty Liver Disease Digestive System Diseases |