A Study of BOS-580 in Obese Subjects at Risk for, or With Biopsy-confirmed, Nonalcoholic Steatohepatitis (NASH) With an Extension
- Conditions
- Nonalcoholic Steatohepatitis (NASH)
- Interventions
- Drug: EfimosferminDrug: Placebo
- Registration Number
- NCT04880031
- Lead Sponsor
- Boston Pharmaceuticals
- Brief Summary
This is a randomized, blinded, placebo-controlled study of Efimosfermin in obese participants at risk for, or with biopsy-confirmed, nonalcoholic steatohepatitis (NASH), with a single arm open-label extension. It includes Parts A, B, C and D.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 231
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort A1: Efimosfermin Dose 1 or placebo (PBO) Efimosfermin - Cohort A1: Efimosfermin Dose 1 or placebo (PBO) Placebo - Cohort A2: Efimosfermin Dose 2 or PBO Efimosfermin - Cohort A2: Efimosfermin Dose 2 or PBO Placebo - Cohort A3: Efimosfermin Dose 3 or PBO Efimosfermin - Cohort A3: Efimosfermin Dose 3 or PBO Placebo - Cohort A4: Efimosfermin Dose 4 or PBO Efimosfermin - Cohort A4: Efimosfermin Dose 4 or PBO Placebo - Cohort A5: Efimosfermin Dose 5 or PBO Efimosfermin - Cohort A5: Efimosfermin Dose 5 or PBO Placebo - Part B: Efimosfermin Dose 1 or PBO Efimosfermin - Part B: Efimosfermin Dose 1 or PBO Placebo - Part C: Efimosfermin Dose 1 Efimosfermin - Part D: Efimosfermin Dose 6 or PBO Efimosfermin - Part D: Efimosfermin Dose 6 or PBO Placebo - Part D: Efimosfermin Dose 1 or PBO Efimosfermin - Part D: Efimosfermin Dose 1 or PBO Placebo -
- Primary Outcome Measures
Name Time Method Part A, Part B, Part C, and Part D: Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) Until End of study/Early Termination (Day 393) The effects of Efimosfermin on safety and tolerability will be assessed.
Part A, Part B, Part C, and Part D: Changes from Baseline in systolic and diastolic blood pressure (BP) Baseline, Week 12 (Day 85, Part A), Week 24 (Day 169, Part B), Week 56 (Day 393, Part C), and Weeks 36 (Day 253), and 48 (Day 337) (Part D) The effects of Efimosfermin on safety and tolerability will be assessed.
Part A, Part B, Part C, and Part D: Changes from Baseline in heart rate Baseline, Week 12 (Day 85, Part A), Week 24 (Day 169, Part B), Week 56 (Day 393, Part C), and Weeks 36 (Day 253), and 48 (Day 337) (Part D) The effects of Efimosfermin on safety and tolerability will be assessed.
Part A, Part B, Part C, and Part D: Number of participants with Grade 3 and Grade 4 laboratory abnormalities Baseline, Week 12 (Day 85, Part A), Week 24 (Day 169, Part B), Week 56 (Day 393, Part C), and Weeks 36 (Day 253), and 48 (Day 337) (Part D) The effects of Efimosfermin on safety and tolerability will be assessed.
- Secondary Outcome Measures
Name Time Method Part A only: Efimosfermin serum concentration on Day 8 of the first dose Day 8 The pharmacokinetics (PK) of Efimosfermin will be assessed.
Part A only: Efimosfermin serum concentration at the end of the dosing interval (Ctrough) 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 PK of Efimosfermin will be assessed.
Part B only: Efimosfermin serum concentration on Day 7 Day 7 The PK of Efimosfermin will be assessed.
Part B and Part C: Efimosfermin serum concentration at the end of the dosing interval (Ctrough) 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) The PK of Efimosfermin will be assessed.
Part B and Part C: Area under the serum concentration-time curve (AUC) for Efimosfermin for one dosing interval at steady state At Days 121, 127, 134, 316, 323, 330 and pre-dose at Days 141 and 337 The PK of Efimosfermin will be assessed.
Trial Locations
- Locations (46)
Central Research Associates
🇺🇸Birmingham, Alabama, United States
Arizona Liver Health
🇺🇸Tucson, Arizona, United States
Liver Institute PPLC
🇺🇸Tucson, Arizona, United States
QLMC
🇺🇸Tucson, Arizona, United States
Alliance Research Institute
🇺🇸Canoga Park, California, United States
Ark Clinical Research
🇺🇸Fountain Valley, California, United States
Fresno Clinical Research Center
🇺🇸Fresno, California, United States
Catalina Research Institute
🇺🇸Montclair, California, United States
Knowledge Research Center
🇺🇸Orange, California, United States
FOMAT Medical Research
🇺🇸Oxnard, California, United States
Scroll for more (36 remaining)Central Research Associates🇺🇸Birmingham, Alabama, United States