A Study of BOS-580 in Obese Subjects at Risk for, or With Biopsy-confirmed, Nonalcoholic Steatohepatitis (NASH)

A Phase 2a, Randomized, Blinded, Placebo-controlled Study of BOS-580 in Obese Subjects at Risk for, or With Biopsy-confirmed, Nonalcoholic Steatohepatitis (NASH)

This is a safety study to evaluate BOS-580 administered subcutaneously over 12 weeks in Part A or 24 weeks in Part B.

Study Overview

• Status: Recruiting
• Conditions: Nonalcoholic Steatohepatitis (NASH)
• Intervention / Treatment: Drug: BOS-580; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Study Medical Director; Phone Number: (617) 655-9681; Email: clinicaltrials@bostonpharmaceuticals.com

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Completed
      • Central Research Associates
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Recruiting
      • Arizona Liver Health
    • Peoria, Arizona, United States, 85381
      • Recruiting
      • Arizona Liver Health
    • Tucson, Arizona, United States, 85712
      • Recruiting
      • Arizona Liver Health
    • Tucson, Arizona, United States, 85712
      • Completed
      • QLMC
    • Tucson, Arizona, United States, 85712
      • Completed
      • Liver Institute PPLC
  • California
    • Canoga Park, California, United States, 91304
      • Recruiting
      • Alliance Research Institute
    • Fresno, California, United States, 92720
      • Recruiting
      • Fresno Clinical Research Center
    • Los Angeles, California, United States, 90057
      • Withdrawn
      • LA Universal
    • Montclair, California, United States, 91763
      • Completed
      • Catalina Research Institute
    • Rialto, California, United States, 92377
      • Recruiting
      • Inland Empire Clinical Trials
  • Florida
    • Fort Myers, Florida, United States, 33907
      • Recruiting
      • Southwest General Healthcare Center
    • Fort Myers, Florida, United States, 33912
      • Recruiting
      • Covenant Metabolic Specialists - Fort Myers
    • Hialeah Gardens, Florida, United States, 33016
      • Recruiting
      • Evolution Clinical Trials
    • Kendall, Florida, United States, 33176
      • Recruiting
      • Entrust Clinical Research Center
    • Lehigh Acres, Florida, United States, 33976
      • Completed
      • Galenus Group
    • Miami, Florida, United States, 33155
      • Recruiting
      • Miami Clinical Research
    • Miami, Florida, United States, 33126
      • Recruiting
      • G+C Research Group
    • Miami, Florida, United States, 33156
      • Recruiting
      • Advanced Clinical Research
    • Miami, Florida, United States, 33173
      • Recruiting
      • Century Research
    • Miami, Florida, United States, 33173
      • Recruiting
      • Admed Research
    • Miami Lakes, Florida, United States, 33014
      • Completed
      • Panex Clinical Research
    • Orange City, Florida, United States, 32763
      • Withdrawn
      • Gastroenterologist of Greater Orlando
    • Sarasota, Florida, United States, 34240
      • Recruiting
      • Covenant Metabolic Specialists - Sarasota
  • Illinois
    • Chicago, Illinois, United States, 60621
      • Withdrawn
      • Eagle Clinical Research
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Recruiting
      • Tandem Clinical Research
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Withdrawn
      • GI Associates & Endocsopy Center
  • Missouri
    • Kansas City, Missouri, United States, 64131
      • Recruiting
      • Kansas City Research Institute
  • New Jersey
    • Warren, New Jersey, United States, 07059
      • Withdrawn
      • IMA Clinical Research
  • New Mexico
    • Albuquerque, New Mexico, United States, 87108
      • Withdrawn
      • Lovelace
  • North Carolina
    • Fayetteville, North Carolina, United States, 28304
      • Recruiting
      • Coastal Research Institute, LLC
    • Raleigh, North Carolina, United States, 27612
      • Withdrawn
      • M3 Wake Research Associates
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Completed
      • Lillestol Research LLC
  • Ohio
    • Mentor, Ohio, United States, 44060
      • Withdrawn
      • Great Lakes Gastroenterology
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • Recruiting
      • Velocity Clinical Research
  • Texas
    • Austin, Texas, United States, 78757
      • Recruiting
      • Pinnacle Clinical Research - Austin
    • Austin, Texas, United States, 78745
      • Recruiting
      • Accelemed Research
    • Bellaire, Texas, United States, 77401
      • Recruiting
      • Apex Mobile Clinical Research
    • Brownsville, Texas, United States, 78520
      • Recruiting
      • South Texas Research Institute-Brownsville
    • Edinburg, Texas, United States, 75839
      • Recruiting
      • South Texas Research Institute-Edinburg
    • Houston, Texas, United States, 77079
      • Recruiting
      • Houston Research Institute
    • Houston, Texas, United States, 77030
      • Withdrawn
      • Liver Specialist of Texas
    • San Antonio, Texas, United States, 78215
      • Recruiting
      • American Research Corporation at Texas Liver Institute
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • Pinnacle Clinical Research - San Antonio
    • San Antonio, Texas, United States, 78209
      • Recruiting
      • Quality Research, Inc
  • Utah
    • Salt Lake City, Utah, United States, 84117
      • Completed
      • Olympus Family Medicine
    • South Ogden, Utah, United States, 84405
      • Completed
      • South Ogden Family Medicine
  • Washington
    • Seattle, Washington, United States, 98105
      • Recruiting
      • Liver Institute Northwest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A and Part B: Changes from Baseline to Week 12 (Day 85) in systolic and diastolic blood pressure (BP)	The effects of BOS-580 on safety and tolerability will be assessed.	Baseline, Week 12 (Day 85)
Part A and Part B: Changes from Baseline to Week 12 (Day 85) in heart rate	The effects of BOS-580 on safety and tolerability will be assessed.	Baseline, Week 12 (Day 85)
Part A and Part B: Number of participants with treatment-emergent adverse events (TEAE) and treatment-emergent serious adverse events (TESAE)	The effects of BOS-580 on safety and tolerability will be assessed.	Until End of study/Early Termination (Day 197)
Part A and Part B: Number of participants with Grade 3 and Grade 4 laboratory abnormalities at Week 12 (Day 85)	The effects of BOS-580 on safety and tolerability will be assessed.	Week 12 (Day 85)
Part B only: Changes from Baseline to Week 24 (Day 169) and Week 28 (Day 197) in systolic and diastolic BP	The effects of BOS-580 on safety and tolerability will be assessed.	Baseline, Week 24 (Day 169), Week 28 (Day 197)
Part B only: Changes from Baseline to Week 24 (Day 169) and Week 28 (Day 197) in heart rate	The effects of BOS-580 on safety and tolerability will be assessed.	Baseline, Week 24 (Day 169), Week 28 (Day 197)
Part B only: Number of participants with Grade 3 and Grade 4 laboratory abnormalities at Week 24 (Day 169) and Week 28 (Day 197)	The effects of BOS-580 on safety and tolerability will be assessed.	Week 24 (Day 169) and Week 28 (Day 197)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A only: BOS-580 serum concentration on Day 8 of the first dose	The pharmacokinetics (PK) of BOS-580 will be assessed.	Day 8
Part A only: BOS-580 serum concentration at the end of the dosing interval (Ctrough)	The pharmacokinetics (PK) of BOS-580 will be assessed.	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
Part B only: BOS-580 serum concentration on Day 7	The PK of BOS-580 will be assessed.	Day 7
Part B only: BOS-580 serum concentration at the end of the dosing interval (Ctrough)	The PK of BOS-580 will be assessed.	Pre-dose at Days 29, 57, 85, 113, 141, 169 and at Day 196 (End of study/Early Termination)
Part B Only: Area under the serum concentration-time curve (AUC) for BOS-580 for one dosing interval at steady state	The PK of BOS-580 will be assessed.	At Days 121, 127, 134 and pre-dose at Day 141

Collaborators and Investigators

• Sponsor: Boston Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2021
• Primary Completion (Estimated): December 15, 2024
• Study Completion (Estimated): December 15, 2024

Study Registration Dates

• First Submitted: May 5, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (Actual): May 10, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetics; Tolerability; BOS-580
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: BOS-580-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No