Nonalcoholic Steatohepatitis (NASH) Clinical Trial
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)
This is a safety study to evaluate BOS-580 administered subcutaneously over 12 weeks in Part A or 24 weeks in Part B.
| Status | Recruiting |
| Enrollment | 180 |
| Est. completion date | December 15, 2024 |
| Est. primary completion date | December 15, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | 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). |
| Country | Name | City | State |
|---|---|---|---|
| United States | Lovelace | Albuquerque | New Mexico |
| United States | Accelemed Research | Austin | Texas |
| United States | Pinnacle Clinical Research - Austin | Austin | Texas |
| United States | Apex Mobile Clinical Research | Bellaire | Texas |
| United States | Central Research Associates | Birmingham | Alabama |
| United States | South Texas Research Institute-Brownsville | Brownsville | Texas |
| United States | Alliance Research Institute | Canoga Park | California |
| United States | Arizona Liver Health | Chandler | Arizona |
| United States | Eagle Clinical Research | Chicago | Illinois |
| United States | Velocity Clinical Research | East Greenwich | Rhode Island |
| United States | South Texas Research Institute-Edinburg | Edinburg | Texas |
| United States | Lillestol Research LLC | Fargo | North Dakota |
| United States | Coastal Research Institute, LLC | Fayetteville | North Carolina |
| United States | GI Associates & Endocsopy Center | Flowood | Mississippi |
| United States | Covenant Metabolic Specialists - Fort Myers | Fort Myers | Florida |
| United States | Southwest General Healthcare Center | Fort Myers | Florida |
| United States | Fresno Clinical Research Center | Fresno | California |
| United States | Evolution Clinical Trials | Hialeah Gardens | Florida |
| United States | Houston Research Institute | Houston | Texas |
| United States | Liver Specialist of Texas | Houston | Texas |
| United States | Kansas City Research Institute | Kansas City | Missouri |
| United States | Entrust Clinical Research Center | Kendall | Florida |
| United States | Galenus Group | Lehigh Acres | Florida |
| United States | LA Universal | Los Angeles | California |
| United States | Tandem Clinical Research | Marrero | Louisiana |
| United States | Great Lakes Gastroenterology | Mentor | Ohio |
| United States | Admed Research | Miami | Florida |
| United States | Advanced Clinical Research | Miami | Florida |
| United States | Century Research | Miami | Florida |
| United States | G+C Research Group | Miami | Florida |
| United States | Miami Clinical Research | Miami | Florida |
| United States | Panex Clinical Research | Miami Lakes | Florida |
| United States | Catalina Research Institute | Montclair | California |
| United States | Gastroenterologist of Greater Orlando | Orange City | Florida |
| United States | Arizona Liver Health | Peoria | Arizona |
| United States | M3 Wake Research Associates | Raleigh | North Carolina |
| United States | Inland Empire Clinical Trials | Rialto | California |
| United States | Olympus Family Medicine | Salt Lake City | Utah |
| United States | American Research Corporation at Texas Liver Institute | San Antonio | Texas |
| United States | Pinnacle Clinical Research - San Antonio | San Antonio | Texas |
| United States | Quality Research, Inc | San Antonio | Texas |
| United States | Covenant Metabolic Specialists - Sarasota | Sarasota | Florida |
| United States | Liver Institute NorthWest | Seattle | Washington |
| United States | South Ogden Family Medicine | South Ogden | Utah |
| United States | Arizona Liver Health | Tucson | Arizona |
| United States | Liver Institute PPLC | Tucson | Arizona |
| United States | QLMC | Tucson | Arizona |
| United States | IMA Clinical Research | Warren | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Boston Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | |
| Primary | 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) | |
| Primary | 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) | |
| Primary | 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) | |
| Primary | 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) | |
| Primary | 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) | |
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | Part B only: BOS-580 serum concentration on Day 7 | The PK of BOS-580 will be assessed. | Day 7 | |
| Secondary | 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) | |
| Secondary | 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 |
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