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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
231
Efimosfermin will be administered by subcutaneous injection
Placebo will be administered by subcutaneous injection
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)
The effects of Efimosfermin on safety and tolerability will be assessed.
Time frame: Until End of study/Early Termination (Day 393)
Part A, Part B, Part C, and Part D: Changes from Baseline in systolic and diastolic blood pressure (BP)
The effects of Efimosfermin on safety and tolerability will be assessed.
Time frame: 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)
Part A, Part B, Part C, and Part D: Changes from Baseline in heart rate
The effects of Efimosfermin on safety and tolerability will be assessed.
Time frame: 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)
Part A, Part B, Part C, and Part D: Number of participants with Grade 3 and Grade 4 laboratory abnormalities
The effects of Efimosfermin on safety and tolerability will be assessed.
Time frame: 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)
Part A only: Efimosfermin serum concentration on Day 8 of the first dose
The pharmacokinetics (PK) of Efimosfermin will be assessed.
Time frame: Day 8
Part A only: Efimosfermin serum concentration at the end of the dosing interval (Ctrough)
The PK of Efimosfermin will be assessed.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Central Research Associates
Birmingham, Alabama, United States
Arizona Liver Health
Chandler, Arizona, United States
Arizona Liver Health
Peoria, Arizona, 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
...and 38 more locations
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
Part B only: Efimosfermin serum concentration on Day 7
The PK of Efimosfermin will be assessed.
Time frame: Day 7
Part B and Part C: Efimosfermin serum concentration at the end of the dosing interval (Ctrough)
The PK of Efimosfermin will be assessed.
Time frame: 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)
Part B and Part C: Area under the serum concentration-time curve (AUC) for Efimosfermin for one dosing interval at steady state
The PK of Efimosfermin will be assessed.
Time frame: At Days 121, 127, 134, 316, 323, 330 and pre-dose at Days 141 and 337