efimosfermin alfa (GSK6519754) / Novartis, Boston Pharma, GSK - LARVOL DELTA

ALLSTAR: A Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Compared With Placebo in Adult Participants With Alcohol-related Liver Disease (ALD) (clinicaltrials.gov) - P2 | N=274 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Efimosfermin Alfa Administered as a Single Dose to Healthy Participants of Chinese, Japanese, and White/u200bEuropean Ancestry (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

Trial completion • Hepatology • Metabolic Dysfunction-Associated Steatotic Liver Disease

ALLSTAR: A Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Compared With Placebo in Adult Participants With Alcohol-related Liver Disease (ALD) (clinicaltrials.gov) - P2 | N=274 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P2 trial • Hepatology

NEBULA-1: A Pivotal Clinical Study to Investigate the Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH) (clinicaltrials.gov) - P3 | N=1740 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Fibrosis • Hepatology • Immunology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

NEBULA-2: A Study to Investigate Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH) (clinicaltrials.gov) - P3 | N=380 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Fibrosis • Hepatology • Immunology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

Efimosfermin alfa: Initiation of P3 NEBULA-1 trial (NCT07701993) for F4 MASH in Q3 2026 (GSK) - Q2 2026 Results: Initiation of P3 NEBULA-2 trial (NCT07704892) for F4 MASH in Q3 2026

Trial initiation date • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH (clinicaltrials.gov) - P2 | N=42 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Dec 2027 ➔ Jul 2028 | Trial primary completion date: Nov 2027 ➔ Jul 2028

Trial completion date • Trial primary completion date • Fibrosis • Hepatology • Immunology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Efimosfermin Alfa Administered as a Single Dose to Healthy Participants of Chinese, Japanese, and White/European Ancestry (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting

Enrollment closed • Hepatology • Metabolic Dysfunction-Associated Steatotic Liver Disease

NEBULA-2: A Study to Investigate Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH) (clinicaltrials.gov) - P3 | N=380 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P3 trial • Fibrosis • Hepatology • Immunology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

NEBULA-1: A Pivotal Clinical Study to Investigate the Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH) (clinicaltrials.gov) - P3 | N=1740 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P3 trial • Fibrosis • Hepatology • Immunology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

306246: A clinical study to investigate the safety and tolerability of efimosfermin alfa injection in participants with known or suspected F2- or F3-stage MASH (BOS-580-302) (clinicaltrialsregister.eu) - P2/3 | N=90 | Not yet recruiting | Sponsor: Glaxosmithkline Research & Development Limited

New P2/3 trial • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

301160: A pivotal clinical study to investigate the safety and efficacy of efimosfermin alfa injection in participants with biopsyconfirmed F2- or F3-stage MASH (BOS-580-301) (clinicaltrialsregister.eu) - P2/3 | N=14 | Not yet recruiting | Sponsor: Glaxosmithkline Research & Development Limited

New P2/3 trial • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

Once-monthly efimosfermin alfa in participants with metabolic dysfunction-associated steatohepatitis with F2/F3 fibrosis: post hoc results from a 24-week, randomized, double-blind, placebo-controlled, phase 2 trial (EASL 2026) - P2 | "Efimosfermin (both doses) produced greater and simultaneous improvements in LSM, ELF, and fibrosis versus placebo; the strong correlation between ELF and LSM improvements supports an early and sustained anti-fibrotic effect. Although there were study limitations with a small sample size of pts receiving efimosfermin 225 mg and the short duration used to assess clinical benefits, these NIT findings complement the histological results and support continued evaluation in F2/F3 MASH for longer durations in the Phase 3 trials."

Clinical • Late-breaking abstract • P2 data • Retrospective data • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • FGF21

GSK’s investigational liver therapy, efimosfermin, receives US FDA Breakthrough Therapy and EMA Priority Medicines (PRIME) designations for MASH (GSK Press Release) - "The two designations were supported by data from MASH patients with moderate to advanced (F2/F3) and cirrhotic (F4) fibrosis. This includes phase II data at 48 weeks for F2/F3 patients who showed fibrosis improvement and MASH resolution with once-monthly efimosfermin versus placebo."

Breakthrough therapy • European regulatory • Metabolic Dysfunction-Associated Steatohepatitis

Efimosfermin alfa: Initiation of P3 NEBULA-1 trial for F4 MASH in H2 2026 (GSK) - Q1 2026 Results: Initiation of P3 NEBULA-2 trial for F4 MASH in H2 2026

New P3 trial • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

A Study of Efimosfermin Alfa in Adults With Hepatic Impairment (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology • Metabolic Dysfunction-Associated Steatotic Liver Disease

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Efimosfermin Alfa Administered as a Single Dose to Healthy Participants of Chinese, Japanese, and White/European Ancestry (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting | Trial primary completion date: Apr 2026 ➔ Aug 2026

Enrollment open • Trial primary completion date • Hepatology • Metabolic Dysfunction-Associated Steatotic Liver Disease

Once-Monthly Efimosfermin Alfa for Up to 48 Weeks in MASH With F2/F3 Fibrosis: Results From a Phase 2, Open-Label Extension Study. (PubMed, Gastroenterol Hepatol (N Y)) - No abstract available

Journal • P2 data • Fibrosis • Immunology • Metabolic Dysfunction-Associated Steatohepatitis

Efimosfermin alfa (BOS-580) once per month in people with metabolic dysfunction-associated steatohepatitis with F2 or F3 fibrosis: results from a 24-week, randomised, double-blind, placebo-controlled, phase 2 trial. (PubMed, Lancet) - P2 | "In this phase 2 trial, treatment with efimosfermin once per month was generally well tolerated in participants with biopsy-confirmed MASH and F2 or F3 fibrosis. These results support the further development of efimosfermin for treatment of MASH-related fibrosis."

Journal • P2 data • Fibrosis • Hepatology • Immunology • Inflammation • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • FGF21

A Study of Efimosfermin Alfa in Adults With Hepatic Impairment (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P1 trial • Hepatology • Metabolic Dysfunction-Associated Steatotic Liver Disease

ZENITH-2: A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected F2- or F3-stage MASH (clinicaltrials.gov) - P3 | N=1250 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Efimosfermin Alfa Administered as a Single Dose to Healthy Participants of Chinese, Japanese, and White/European Ancestry (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P1 trial • Hepatology • Metabolic Dysfunction-Associated Steatotic Liver Disease

GSK presents data from its advancing liver pipeline at AASLD 2025 (GSK Press Release) - "21 abstracts highlight advances in the treatment of liver conditions, building from GSK’s expertise in inflammation and fibrosis; Phase II B-Sure study sub-analysis shows durability of functional cure in chronic hepatitis B (CHB) patients treated with bepirovirsen and pegylated interferon (Peg-IFN); Late breaking results for once-monthly efimosfermin in metabolic dysfunction-associated steatohepatitis (MASH), supporting the start of phase III clinical trials"

Clinical data • Hepatitis B • Metabolic Dysfunction-Associated Steatohepatitis

BOS-580-201: A Study of BOS-580 in Obese Subjects at Risk for, or With Biopsy-confirmed, Nonalcoholic Steatohepatitis (NASH) With an Extension (clinicaltrials.gov) - P2 | N=231 | Completed | Sponsor: Boston Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis • Obesity

ZENITH-1: A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH (clinicaltrials.gov) - P3 | N=1200 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P3 trial • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease