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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
Must not have
History of type 1 diabetes, diabetic ketoacidosis, or positive glutamic acid decarboxylase (GAD) auto-antibodies (latent autoimmune diabetes in adults)
Documented clinical, laboratory or radiologic evidence of cirrhosis (compensated or decompensated)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose at days 29, 57, 85, 113, 141, 169, 225, 253, 281, 309, 316, 323, 330, 337, 365 and at day 393 (end of study/early termination)

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%.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have type 1 diabetes or have had diabetic ketoacidosis or tested positive for GAD auto-antibodies.
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I have been diagnosed with cirrhosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose at days 29, 57, 85, 113, 141, 169, 225, 253, 281, 309, 316, 323, 330, 337, 365 and at day 393 (end of study/early termination)
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose at days 29, 57, 85, 113, 141, 169, 225, 253, 281, 309, 316, 323, 330, 337, 365 and at day 393 (end of study/early termination) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part A, Part B, Part C, and Part D: Changes from Baseline in heart rate
Part A, Part B, Part C, and Part D: Changes from Baseline in systolic and diastolic blood pressure (BP)
Part A, Part B, Part C, and Part D: Number of participants with Grade 3 and Grade 4 laboratory abnormalities
+1 more
Secondary study objectives
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 and Part C: Area under the serum concentration-time curve (AUC) for BOS-580 for one dosing interval at steady state
+12 more

Trial Design

9Treatment groups
Experimental Treatment
Group I: Part D: BOS-580 Dose 6 or PBOExperimental Treatment2 Interventions
Group II: Part D: BOS-580 Dose 1 or PBOExperimental Treatment2 Interventions
Group III: Part C: BOS-580 Dose 1Experimental Treatment1 Intervention
Group IV: Part B: BOS-580 Dose 1 or PBOExperimental Treatment2 Interventions
Group V: Cohort A5: BOS-580 Dose 5 or PBOExperimental Treatment2 Interventions
Group VI: Cohort A4: BOS-580 Dose 4 or PBOExperimental Treatment2 Interventions
Group VII: Cohort A3: BOS-580 Dose 3 or PBOExperimental Treatment2 Interventions
Group VIII: Cohort A2: BOS-580 Dose 2 or PBOExperimental Treatment2 Interventions
Group IX: 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: Part B: BOS-580 Dose 1 or PBO, Part C: BOS-580 Dose 1, Part D: BOS-580 Dose 6 or PBO, Part D: BOS-580 Dose 1 or PBO, 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 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
~82 spots leftby Jul 2026
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