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Unknown

BOS-580 for Nonalcoholic Steatohepatitis (NASH)

Phase 2
Recruiting
Research Sponsored by Boston Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Liver fibrosis assessment based on a vibration controlled transient elastography (VCTE) liver stiffness measurement (LSM) score of 7.0 to 9.9 kPa (Part A only) inclusive or 7.0 to 12.0 kPa (Part B only) inclusive and Liver injury assessment measured by aspartate aminotransferase (AST) >20U/L.
Participant is either male or female and 18 to 75 years of age inclusive, at the time of signing the informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose at days 15, 29, 43, 57, 71, 85 and 113 (end of study/early termination) for bi-weekly schedule; pre-dose on days 29, 57, 85 and 113 (end of study/early termination) for the monthly schedule
Awards & highlights

Study Summary

This trial is testing a new drug to see if it's safe and effective when taken by injection over 12 weeks.

Who is the study for?
This trial is for obese adults aged 18-75 with a BMI of 30-45 who are at risk for or have NASH, as indicated by specific liver stiffness and injury markers. Candidates must not have cirrhosis, extremely high triglycerides, type 1 diabetes, significant recent weight changes, or an HbA1c >9.5%.Check my eligibility
What is being tested?
The study tests BOS-580's safety in treating NASH over two periods: one group receives the drug subcutaneously for either 12 weeks (Part A) or 24 weeks (Part B), while another group gets a placebo to compare effects.See study design
What are the potential side effects?
Potential side effects of BOS-580 aren't detailed here but typically include reactions at the injection site, gastrointestinal issues, fatigue, and possible allergic responses. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver stiffness is within the required range and my AST levels are above 20U/L.
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I am between 18 and 75 years old and can give informed consent.
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My BMI is between 30 and 45.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose at days 15, 29, 43, 57, 71, 85 and 113 (end of study/early termination) for bi-weekly schedule; pre-dose on days 29, 57, 85 and 113 (end of study/early termination) for the monthly schedule
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose at days 15, 29, 43, 57, 71, 85 and 113 (end of study/early termination) for bi-weekly schedule; pre-dose on days 29, 57, 85 and 113 (end of study/early termination) for the monthly schedule for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A and Part B: Changes from Baseline to Week 12 (Day 85) in heart rate
Part A and Part B: Changes from Baseline to Week 12 (Day 85) in systolic and diastolic blood pressure (BP)
Part A and Part B: Number of participants with Grade 3 and Grade 4 laboratory abnormalities at Week 12 (Day 85)
+4 more
Secondary outcome measures
Part A only: BOS-580 serum concentration at the end of the dosing interval (Ctrough)
Part A only: BOS-580 serum concentration on Day 8 of the first dose
Part B Only: Area under the serum concentration-time curve (AUC) for BOS-580 for one dosing interval at steady state
+2 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Cohort B: BOS-580 Dose 1 or PBOExperimental Treatment2 Interventions
Group II: Cohort A5: BOS-580 Dose 5 or PBOExperimental Treatment2 Interventions
Group III: Cohort A4: BOS-580 Dose 4 or PBOExperimental Treatment2 Interventions
Group IV: Cohort A3: BOS-580 Dose 3 or PBOExperimental Treatment2 Interventions
Group V: Cohort A2: BOS-580 Dose 2 or PBOExperimental Treatment2 Interventions
Group VI: Cohort A1: BOS-580 Dose 1 or placebo (PBO)Experimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Boston PharmaceuticalsLead Sponsor
11 Previous Clinical Trials
680 Total Patients Enrolled

Media Library

BOS-580 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT04880031 — Phase 2
Non-alcoholic Fatty Liver Disease Research Study Groups: Cohort A3: BOS-580 Dose 3 or PBO, Cohort A2: BOS-580 Dose 2 or PBO, Cohort A4: BOS-580 Dose 4 or PBO, Cohort A5: BOS-580 Dose 5 or PBO, Cohort B: BOS-580 Dose 1 or PBO, Cohort A1: BOS-580 Dose 1 or placebo (PBO)
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: BOS-580 Highlights & Side Effects. Trial Name: NCT04880031 — Phase 2
BOS-580 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04880031 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does BOS-580 carry any risks for human patients?

"BOS-580 is still in Phase 2 of clinical trials, so there is not yet data supporting its efficacy. There is, however, some evidence that it is safe for human use which gives it a score of 2."

Answered by AI

What are the main goals of this clinical trial?

"The primary objective of this study, which will be assessed at Week 12 (Day 85), is the number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs). Additionally, this trial will also measure secondary outcomes including average serum drug concentration (Cavg) for BOS-580, maximum serum drug concentration (Cmax) for BOS-580, and time to reach maximum serum concentration (Tmax) for BOS-580."

Answered by AI

Where is this research being conducted?

"Presently, this study is being conducted at 6 different sites. The Miami and Fort Myers locations in the USA are closest to South Ogden. To cut down on travel, it would be best to select a clinic near you if you plan on enrolling."

Answered by AI

If I join this clinical trial, what are the expectations for my involvement?

"This clinical trial is for 102 people between the ages of 18 and 75 who have nonalcoholic steatohepatitis. The following criteria must be met: -Hepatic fat fraction (HFF) measured by magnetic resonance imaging derived proton density fat fraction (MRI-PDFF) ≥10%-Participant is either male or female and 18 to 75 years of age inclusive, at the time of signing the informed consent-Obese participants with body mass index (BMI) within the range of 30 to 45 kg/m^2 (inclusive)-Liver injury and fib"

Answered by AI

Are we still enrolling participants for this research?

"The clinicaltrials.gov website indicates that this particular study is no longer recruiting patients for participation. The trial was originally announced on September 30th, 2021 but the most recent update was on September 26th, 2022. Although this experiment isn't looking for more volunteers, there are 246 other studies that are currently seeking participants."

Answered by AI

Will this study's benefits be available to patients that are 55 and older?

"The age requirement to participate in this clinical trial is between 18-75 years old."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
Florida
What site did they apply to?
Miami Clinical Research
Apex Mobile Clinical Research
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
A Study of BOS-580 in Obese Subjects at Risk for, or With Biopsy-confirmed, Nonalcoholic Steatohepatitis (NASH)
2021. "A Study of BOS-580 in Obese Subjects at Risk for, or With Biopsy-confirmed, Nonalcoholic Steatohepatitis (NASH)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04880031.
All > Autoimmune Hepatitis > Nash
~33 spots leftby Dec 2024
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