A Study of BOS-580 in Obese Subjects at Risk for, or With Biopsy-confirmed, Nonalcoholic Steatohepatitis (NASH)
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| ClinicalTrials.gov Identifier: NCT04880031 |
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Recruitment Status :
Recruiting
First Posted : May 10, 2021
Last Update Posted : January 5, 2024
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Sponsor:
Boston Pharmaceuticals
Information provided by (Responsible Party):
Boston Pharmaceuticals
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Brief Summary:
This is a safety study to evaluate BOS-580 administered subcutaneously over 12 weeks in Part A or 24 weeks in Part B.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Nonalcoholic Steatohepatitis (NASH) | Drug: BOS-580 Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 180 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2a, Randomized, Blinded, Placebo-controlled Study of BOS-580 in Obese Subjects at Risk for, or With Biopsy-confirmed, Nonalcoholic Steatohepatitis (NASH) |
| Actual Study Start Date : | September 30, 2021 |
| Estimated Primary Completion Date : | December 15, 2024 |
| Estimated Study Completion Date : | December 15, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Non-alcoholic fatty liver disease
MedlinePlus related topics:
Biopsy
| Arm | Intervention/treatment |
|---|---|
| Experimental: Cohort A1: BOS-580 Dose 1 or placebo (PBO) |
Drug: BOS-580
BOS-580 will be administered by subcutaneous injection Drug: Placebo Placebo will be administered by subcutaneous injection |
| Experimental: Cohort A2: BOS-580 Dose 2 or PBO |
Drug: BOS-580
BOS-580 will be administered by subcutaneous injection Drug: Placebo Placebo will be administered by subcutaneous injection |
| Experimental: Cohort A3: BOS-580 Dose 3 or PBO |
Drug: BOS-580
BOS-580 will be administered by subcutaneous injection Drug: Placebo Placebo will be administered by subcutaneous injection |
| Experimental: Cohort A4: BOS-580 Dose 4 or PBO |
Drug: BOS-580
BOS-580 will be administered by subcutaneous injection Drug: Placebo Placebo will be administered by subcutaneous injection |
| Experimental: Cohort A5: BOS-580 Dose 5 or PBO |
Drug: BOS-580
BOS-580 will be administered by subcutaneous injection Drug: Placebo Placebo will be administered by subcutaneous injection |
| Experimental: Cohort B: BOS-580 Dose 1 or PBO |
Drug: BOS-580
BOS-580 will be administered by subcutaneous injection Drug: Placebo Placebo will be administered by subcutaneous injection |
Primary Outcome Measures :
- Part A and Part B: Number of participants with treatment-emergent adverse events (TEAE) and treatment-emergent serious adverse events (TESAE) [ Time Frame: Until End of study/Early Termination (Day 197) ]The effects of BOS-580 on safety and tolerability will be assessed.
- Part A and Part B: Changes from Baseline to Week 12 (Day 85) in systolic and diastolic blood pressure (BP) [ Time Frame: Baseline, Week 12 (Day 85) ]The effects of BOS-580 on safety and tolerability will be assessed.
- Part A and Part B: Changes from Baseline to Week 12 (Day 85) in heart rate [ Time Frame: Baseline, Week 12 (Day 85) ]The effects of BOS-580 on safety and tolerability will be assessed.
- Part A and Part B: Number of participants with Grade 3 and Grade 4 laboratory abnormalities at Week 12 (Day 85) [ Time Frame: Week 12 (Day 85) ]The effects of BOS-580 on safety and tolerability will be assessed.
- Part B only: Changes from Baseline to Week 24 (Day 169) and Week 28 (Day 197) in systolic and diastolic BP [ Time Frame: Baseline, Week 24 (Day 169), Week 28 (Day 197) ]The effects of BOS-580 on safety and tolerability will be assessed.
- Part B only: Changes from Baseline to Week 24 (Day 169) and Week 28 (Day 197) in heart rate [ Time Frame: Baseline, Week 24 (Day 169), Week 28 (Day 197) ]The effects of BOS-580 on safety and tolerability will be assessed.
- Part B only: Number of participants with Grade 3 and Grade 4 laboratory abnormalities at Week 24 (Day 169) and Week 28 (Day 197) [ Time Frame: Week 24 (Day 169) and Week 28 (Day 197) ]The effects of BOS-580 on safety and tolerability will be assessed.
Secondary Outcome Measures :
- Part A only: BOS-580 serum concentration on Day 8 of the first dose [ Time Frame: Day 8 ]The pharmacokinetics (PK) of BOS-580 will be assessed.
- Part A only: BOS-580 serum concentration at the end of the dosing interval (Ctrough) [ Time Frame: 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 ]The pharmacokinetics (PK) of BOS-580 will be assessed.
- Part B only: BOS-580 serum concentration on Day 7 [ Time Frame: Day 7 ]The PK of BOS-580 will be assessed.
- Part B only: BOS-580 serum concentration at the end of the dosing interval (Ctrough) [ Time Frame: Pre-dose at Days 29, 57, 85, 113, 141, 169 and at Day 196 (End of study/Early Termination) ]The PK of BOS-580 will be assessed.
- Part B Only: Area under the serum concentration-time curve (AUC) for BOS-580 for one dosing interval at steady state [ Time Frame: At Days 121, 127, 134 and pre-dose at Day 141 ]The PK of BOS-580 will be assessed.
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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) of ≥ 27 kg/m^2
- Hepatic fat fraction (HFF) measured by magnetic resonance imaging derived proton density fat fraction (MRI-PDFF) ≥8%
- 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 20.0 kPa (Part B only) inclusive and Liver injury assessment measured by aspartate aminotransferase (AST) >25U/L. A qualifying historical biopsy (confirmed eligibility based on the central pathology read) supersedes the LSM, controlled attenuation parameter (CAP) score criteria and AST criteria.
- Histopathologically confirmed F2 or F3 stage NASH on a diagnostic liver biopsy performed during Screening or within 6 months prior to the first day of dosing for historical biopsies (Part B only).
- History or presence of at least 2 of 4 components of metabolic syndrome: obesity/overweight, dyslipidemia (high triglycerides and/or low high density lipoprotein [HDL]), type 2 diabetes with elevated glycated hemoglobin (HbA1c), and hypertension.
Exclusion Criteria:
- Documented clinical, laboratory or radiologic evidence of cirrhosis (compensated or decompensated)
- Triglycerides ≥ 500 mg/dL
- Change in body weight (more than 5% self-reported OR 5 kg self-reported change during the previous 3 months from Screening, whichever is smaller)
- History of type 1 diabetes, diabetic ketoacidosis, or positive glutamic acid decarboxylase (GAD) auto-antibodies (latent autoimmune diabetes in adults)
- Hemoglobin A1c > 9.5%
- Subjects with a condition that requires substantial anticoagulant medication may not be eligible for the study enrollment (e.g., deep vein thrombosis).
Information from the National Library of Medicine
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): NCT04880031
Contacts
| Contact: Study Medical Director | (617) 655-9681 | clinicaltrials@bostonpharmaceuticals.com |
Locations
Show 48 study locations
Sponsors and Collaborators
Boston Pharmaceuticals
| Responsible Party: | Boston Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT04880031 |
| Other Study ID Numbers: |
BOS-580-201 |
| First Posted: | May 10, 2021 Key Record Dates |
| Last Update Posted: | January 5, 2024 |
| Last Verified: | June 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Boston Pharmaceuticals:
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BOS-580 Safety Tolerability Pharmacokinetics |
Additional relevant MeSH terms:
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Fatty Liver Non-alcoholic Fatty Liver Disease Liver Diseases Digestive System Diseases |