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Recruiting Phase 3 Interventional

A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH

ClinicalTrials.gov ID: NCT07221227

Public ClinicalTrials.gov record NCT07221227. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 1, 2026, 2:11 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Efficacy of Efimosfermin Alfa in Participants With Biopsy-Confirmed F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-1)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to assess the safety and efficacy of efimosfermin alfa in the resolution of steatohepatitis and improvement of liver-related clinical outcome compared to placebo in individuals with MASH and biopsy-confirmed F2- or F3-stage fibrosis.

Study identification

NCT ID
NCT07221227
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
GlaxoSmithKline
Industry
Enrollment
1,200 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 23, 2025
Primary completion
Mar 28, 2028
Completion
Dec 11, 2031
Last update posted
Jul 26, 2026

2025 – 2031

United States locations

U.S. sites
74
U.S. states
18
U.S. cities
63
Facility City State ZIP Site status
GSK Investigational Site Chandler Arizona 85224 Recruiting
GSK Investigational Site Tucson Arizona 85712 Recruiting
GSK Investigational Site Little Rock Arkansas 72211 Recruiting
GSK Investigational Site Arcadia California 91006 Recruiting
GSK Investigational Site Covina California 91723 Recruiting
GSK Investigational Site Folsom California 95630 Recruiting
GSK Investigational Site Los Angeles California 90057 Recruiting
GSK Investigational Site Montclair California 91763 Recruiting
GSK Investigational Site Riverdale California 30274 Recruiting
GSK Investigational Site San Diego California 92120 Recruiting
GSK Investigational Site Santa Maria California 93458 Recruiting
GSK Investigational Site Van Nuys California 91405 Recruiting
GSK Investigational Site Colorado Springs Colorado 80907 Recruiting
GSK Investigational Site Boynton Beach Florida 33435 Recruiting
GSK Investigational Site Cape Coral Florida 33914 Recruiting
GSK Investigational Site Clermont Florida 34711 Recruiting
GSK Investigational Site Fort Myers Florida 33912 Recruiting
GSK Investigational Site Hialeah Florida 33016 Recruiting
GSK Investigational Site Homestead Florida 33033 Recruiting
GSK Investigational Site Inverness Florida 34452 Recruiting
GSK Investigational Site Jacksonville Florida 32216 Recruiting
GSK Investigational Site Kissimmee Florida 34744 Recruiting
GSK Investigational Site Lakeland Florida 33803 Recruiting
GSK Investigational Site Maitland Florida 32751 Recruiting
GSK Investigational Site Miami Florida 33135 Recruiting
GSK Investigational Site Miami Florida 33144 Recruiting
GSK Investigational Site Miami Florida 33155 Recruiting
GSK Investigational Site Miami Florida 33156 Recruiting
GSK Investigational Site Miami Florida 33173 Recruiting
GSK Investigational Site Miami Florida 33176 Recruiting
GSK Investigational Site Miami Florida 33184 Recruiting
GSK Investigational Site Miami Lakes Florida 33014 Recruiting
GSK Investigational Site Ocala Florida 34471 Recruiting
GSK Investigational Site Palmetto Bay Florida 33157 Recruiting
GSK Investigational Site Sarasota Florida 34201 Recruiting
GSK Investigational Site Marietta Georgia 30060 Recruiting
GSK Investigational Site Topeka Kansas 66606 Recruiting
GSK Investigational Site Bastrop Louisiana 71220 Recruiting
GSK Investigational Site Marrero Louisiana 70072 Recruiting
GSK Investigational Site Kansas City Missouri 64131 Recruiting
GSK Investigational Site Springfield Missouri 62703 Recruiting
GSK Investigational Site St Louis Missouri 63141 Recruiting
GSK Investigational Site Las Vegas Nevada 89106 Recruiting
GSK Investigational Site East Syracuse New York 13057 Recruiting
GSK Investigational Site New York New York 10036 Recruiting
GSK Investigational Site Fayetteville North Carolina 28304 Recruiting
GSK Investigational Site Morehead City North Carolina 28557 Recruiting
GSK Investigational Site Akron Ohio 44320 Recruiting
GSK Investigational Site Springboro Ohio 45066 Recruiting
GSK Investigational Site Westlake Ohio 44145 Recruiting
GSK Investigational Site Chattanooga Tennessee 37421 Recruiting
GSK Investigational Site Arlington Texas 76012 Recruiting
GSK Investigational Site Austin Texas 78704 Recruiting
GSK Investigational Site Austin Texas 78757 Recruiting
GSK Investigational Site Austin Texas 78759 Recruiting
GSK Investigational Site Bellaire Texas 77401 Recruiting
GSK Investigational Site Brownsville Texas 78526 Recruiting
GSK Investigational Site Dallas Texas 75243 Recruiting
GSK Investigational Site DeSoto Texas 75115 Recruiting
GSK Investigational Site Houston Texas 77004 Recruiting
GSK Investigational Site Irving Texas 75061 Recruiting
GSK Investigational Site Richmond Texas 77406 Recruiting
GSK Investigational Site San Antonio Texas 78209 Recruiting
GSK Investigational Site San Antonio Texas 78215 Recruiting
GSK Investigational Site San Antonio Texas 78229 Recruiting
GSK Investigational Site Seabrook Texas 77586 Recruiting
GSK Investigational Site Sugar Land Texas 77479 Recruiting
GSK Investigational Site Tomball Texas 77375 Recruiting
GSK Investigational Site Waco Texas 76710 Recruiting
GSK Investigational Site Waco Texas 76712 Recruiting
GSK Investigational Site West Jordan Utah 84088 Recruiting
GSK Investigational Site Manassas Virginia 20110 Recruiting
GSK Investigational Site Norfolk Virginia 23502 Recruiting
GSK Investigational Site Seattle Washington 98105 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 15 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07221227, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 26, 2026 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07221227 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →