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A Phase 3, two-part, double-blind, randomized, placebo-controlled study to investigate the safety and efficacy of efimosfermin alfa injection in adult
participants with compensated cirrhosis (stage F4 fibrosis) due to metabolic dysfunction-associated steatohepatitis (NEBULA-2)

A study to investigate safety and efficacy of efimosfermin compared with placebo in adult participants with compensated cirrhosis (stage F4 fibrosis) due to MASH (NEBULA-2)

Mendez Patricia

GlaxoSmithKline K.K.

Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan

jp.gskjrct@gsk.com

Mendez Patricia

GlaxoSmithKline K.K.

Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan

+81-120-561-007

jp.gskjrct@gsk.com

Pending

July. 27, 2026

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1. Participants aged between 18 and 75 years at enrollment.
2. Participants with history or presence of at least two components of metablic syndrome.
3. Liver biopsy consistent with cirrhosis (fibrosis stage 4)

1. Participants with other chronic liver diseases.
2. Participants with evidence or history of decompensated liver disease or hepatocellular carcinoma.
3. Participants with history of Type 1 diabetes mellitus or major Type 2 diabetes mellitus complications.
4. History or evidence of chronic pancreatic disease; pancreatic injury or acute pancreatitis within 6 months before screening.
5. A recent history or planned surgical procedures or medications intended to produce significant weight loss.
6. ALT or AST >= 5 times upper limit normal.
7. Current or history of excessive alcohol intake.

Both

Compensated cirrhosis (stage F4 fibrosis) due to metabolic dysfunction-associated steatohepatitis

Part A: Efimosfermin alfa or placebo (SC injection) will be administered.
Part B: Efimosfermin alfa (SC injection) will be administered.

Part A: Proportion of participants achieving improvement in liver fibrosis by >= 1 stage and no worsening of MASH

- Part A: Proportion of participants achieving change from Baseline in VSTE-LSM and ELF score at Week 96.
- Part A: Change from Baseline in VCTE-LSM at Week 96.
- Part A: Proportion of participants with treatment-emergent adverse events (TEAEs) and TEAEs by severity at Week 96.
- Part A: Proportion of participants with TEAEs leading to discontinuation and TEAEs leading to discontinuation by severity at Week 96.
- Part A: Proportion of participants with Grade 3 and Greade 4 laboratory abnormalities at Week 96.

+81-584-81-3341

No

Argentina/Australia/Austria/Belgium/Brazil/Bulgaria/Canada/Chile/China/France/Germany/Greece/Hong Kong/India/Israel/Italy/South Korea/Mexico/Netherlands/New Zealand/Poland/Saudi Arabia/Singapore/Spain/Taiwan/Turkiye/United Kingdom/United States/Puerto Rico