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Efimosfermin

Phase 2

Nonalcoholic Steatohepatitis (NASH) | Small molecule | Infectious Disease |GSK plc|Last Updated: Oct 30, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment231
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04880031A Study of BOS-580 in Obese Subjects at Risk for, or With Biopsy-confirmed, Nonalcoholic Steatohepatitis (NASH) With an ExtensionPHASE2 COMPLETED 231 — — Sep 30, 2021Oct 27, 2025Oct 30, 202548 United States
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Study Endpoints
Primary Endpoints
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 Endpoints
Part A only: Efimosfermin serum concentration on Day 8 of the first dose
Day 8
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
Part B only: Efimosfermin serum concentration on Day 7
Day 7
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort A1: Efimosfermin Dose 1 or placebo (PBO)EXPERIMENTAL -
Cohort A2: Efimosfermin Dose 2 or PBOEXPERIMENTAL -
Cohort A3: Efimosfermin Dose 3 or PBOEXPERIMENTAL -
Cohort A4: Efimosfermin Dose 4 or PBOEXPERIMENTAL -
Cohort A5: Efimosfermin Dose 5 or PBOEXPERIMENTAL -
Part B: Efimosfermin Dose 1 or PBOEXPERIMENTAL -
Part C: Efimosfermin Dose 1EXPERIMENTAL -
Part D: Efimosfermin Dose 6 or PBOEXPERIMENTAL -
Part D: Efimosfermin Dose 1 or PBOEXPERIMENTAL -
Interventions
NameTypeDescription
EfimosferminDRUGEfimosfermin will be administered by subcutaneous injection
PlaceboDRUGPlacebo will be administered by subcutaneous injection
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites48

Inclusion Criteria (Part A and Part B): * 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...

Countries:United States
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