NCT07221188 (ZENITH-2) is a Phase 3 clinical trial of Efimosfermin Alfa in Non-alcoholic Fatty Liver Disease, sponsored by GlaxoSmithKline.

Who is sponsoring NCT07221188?

NCT07221188 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT07221188?

Interventions in NCT07221188: Efimosfermin Alfa, Placebo.

What condition does NCT07221188 study?

NCT07221188 studies Non-alcoholic Fatty Liver Disease.

Is NCT07221188 still recruiting?

NCT07221188 is currently recruiting now. Last updated 16 April 2026.

Last reviewed 2026-04-16 · How we verify

NCT07221188: ZENITH-2

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected F2- or F3-stage MASH

Recruiting now Phase 3 Last updated 16 April 2026

What this trial tests

Phase 3 trial testing Efimosfermin Alfa in Non-alcoholic Fatty Liver Disease in 1,250 participants. Currently enrolling.

Timeline

12 December 2025

Primary endpoint
24 March 2028

24 March 2028

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	1,250
Start date	12 December 2025
Primary completion	24 March 2028
Estimated completion	24 March 2028
Sites	43 locations across United States

Drugs / interventions tested

Efimosfermin Alfa — full drug profile →
Placebo

Conditions studied

Non-alcoholic Fatty Liver Disease — all drugs for Non-alcoholic Fatty Liver Disease →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 75, any sex, with Non-alcoholic Fatty Liver Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will evaluate the safety and tolerability of Efimosfermin Alfa for participants with known or suspected MASH with fibrosis consistent with stage F2 or F3.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Once-Monthly Efimosfermin Alfa for Up to 48 Weeks in MASH With F2/F3 Fibrosis: Results From a Phase 2, Open-Label Extension Study.
· 2025 · PMID 41660650

Verify or expand the search:

Other recruiting trials for Non-alcoholic Fatty Liver Disease

Currently open trials in the same condition.

NCT07358546 — A Study of Efimosfermin Alfa in Adults With Hepatic Impairment · Phase 1 · recruiting
NCT07335198 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Efimosfermin Alfa Administered as a · Phase 1 · recruiting
NCT07221227 — A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH · Phase 3 · recruiting
NCT07514377 — JiGenerations Health Cohort Study：Parental Exposure and Intergenerational Health in China · active not recruiting
NCT06950710 — Mechanisms of Macrophage Polarization in HIRI in Patients With NAFLD · active not recruiting

Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT07221188 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 16 April 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07221188.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing