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A Study of BOS-580 in Obese Subjects at Risk for Nonalcoholic Steatohepatitis (NASH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04880031
Recruitment Status : Recruiting
First Posted : May 10, 2021
Last Update Posted : March 28, 2022
Sponsor:
Information provided by (Responsible Party):
Boston Pharmaceuticals

Brief Summary:
This is a safety study to evaluate BOS-580 administered subcutaneously over 12 weeks.

Condition or disease Intervention/treatment Phase
Nonalcoholic Steatohepatitis (NASH) Drug: BOS-580 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 12-week Phase 2a Randomized, Blinded, Placebo Controlled Study of BOS-580 in Obese Subjects at Risk for Nonalcoholic Steatohepatitis (NASH)
Actual Study Start Date : September 30, 2021
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 113) ]
    The effects of BOS-580 on safety and tolerability will be assessed.

  2. 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.

  3. 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.

  4. Number of participants with Grade 3-4 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.


Secondary Outcome Measures :
  1. Maximum serum drug concentration (Cmax) for BOS-580 [ Time Frame: At Days 1, 15, 29, 43, 57, 85 (Pre-dose), at Day 8, and at End of study/Early Termination (Day 113) ]
    The pharmacokinetics (PK) of BOS-580 will be assessed.

  2. Minimum serum drug concentration (Cmin) for BOS-580 [ Time Frame: At Days 1, 15, 29, 43, 57, 85 (Pre-dose), at Day 8, and at End of study/Early Termination (Day 113) ]
    The PK of BOS-580 will be assessed.

  3. Average serum drug concentration (Cavg) for BOS-580 [ Time Frame: At Days 1, 15, 29, 43, 57, 85 (Pre-dose), at Day 8, and at End of study/Early Termination (Day 113) ]
    The PK of BOS-580 will be assessed.

  4. Time to reach maximum serum concentration (Tmax) for BOS-580 [ Time Frame: At Days 1, 15, 29, 43, 57, 85 (Pre-dose), at Day 8, and at End of study/Early Termination (Day 113) ]
    The PK of BOS-580 will be assessed.

  5. Area under the serum concentration-time curve (AUC) from time zero to time of last measurable concentration (AUClast) for BOS-580 [ Time Frame: At Days 1, 15, 29, 43, 57, 85 (Pre-dose), at Day 8, and at End of study/Early Termination (Day 113) ]
    The PK of BOS-580 will be assessed.

  6. Area under the serum concentration-time curve during a dosage interval (AUCtau) for BOS-580 [ Time Frame: At Days 1, 15, 29, 43, 57, 85 (Pre-dose), at Day 8, and at End of study/Early Termination (Day 113) ]
    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) within the range of 30 to 45 kg/m^2 (inclusive)
  • Hepatic fat fraction (HFF) measured by magnetic resonance imaging derived proton density fat fraction (MRI-PDFF) ≥10%
  • Liver injury and fibrosis assessment based on vibration controlled transient elastography (VCTE) liver stiffness measurement (LSM) score between 7 and 9.9kPa inclusive and aspartate aminotransferase (AST) >20U/L.

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)
  • History of type 1 diabetes, diabetic ketoacidosis, or positive glutamic acid decarboxylase (GAD) auto-antibodies (latent autoimmune diabetes in adults)
  • Hemoglobin A1c > 9.5%.

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
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Contact: Etienne Dumont, MD (484) 986 8699 clinicaltrials@bostonpharmaceuticals.com

Locations
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United States, Alabama
Central Research Associates Recruiting
Birmingham, Alabama, United States, 35205
United States, Arizona
QLMC Recruiting
Tucson, Arizona, United States, 85712
United States, California
Catalina Research Institute Recruiting
Montclair, California, United States, 91763
United States, Florida
Southwest General Healthcare Center Recruiting
Fort Myers, Florida, United States, 33907
Galenus Group Recruiting
Lehigh Acres, Florida, United States, 33976
Panex Clinical Research Recruiting
Miami Lakes, Florida, United States, 33014
Century Research Recruiting
Miami, Florida, United States, 33173
United States, New Mexico
Lovelace Withdrawn
Albuquerque, New Mexico, United States, 87108
United States, North Dakota
Lillestol Research LLC Recruiting
Fargo, North Dakota, United States, 58104
United States, Texas
Accelemed Research Recruiting
Austin, Texas, United States, 78745
United States, Utah
Olympus Family Medicine Recruiting
Salt Lake City, Utah, United States, 84117
South Ogden Family Medicine Recruiting
South Ogden, Utah, United States, 84405
United States, Washington
Liver Institute NorthWest Recruiting
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Boston Pharmaceuticals
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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: March 28, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston Pharmaceuticals:
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