DelfaGLP-1 Atlas

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Active not recruitingPhase 2

Study to Evaluate Efficacy, Safety and Tolerability of HM15211(Efocipegtrutide) in Subjects

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Efficacy, Safety and Tolerability of HM15211(Efocipegtrutide) Treatment for 12 Months in Subjects With Biopsy Confirmed NASH

Asset

Efocipegtrutide

Subcutaneous · GLP-1 / GIP / glucagon triple

Listed sites

60

Recruiting sites

—

Enrollment

215

actual

Study population

MASH / NAFLD / liver fibrosis

Key I/E criterion

•BMI ≥18

Primary endpoint

•MASH resolution, no fibrosis worsening

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04505436
Org study IDHM-TRIA-201

Timeline

Milestones

Study start2020-07-31actual
Study first posted2020-08-10actual
Last update posted2025-11-19actual
Primary completion2026-06-27estimated
Study completion2026-07-27estimated

Assets

Investigational agents

Efocipegtrutide

Study populations

Who this study enrolls

MASH / NAFLD / liver fibrosis

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•United States Sites: Adults ≥ 18 to ≤ 70 years.
•Korean Sites: Adults ≥ 19 to ≤ 70 years.
•BMI ≥ 18 kg/m2, with stable body weight (defined as change < 5%) by history for 3 months prior to screening or since baseline liver biopsy, whichever is earlier.
•Subjects have a diagnosis of non-cirrhotic NASH with liver fibrosis (Fibrosis stage F1-F3) confirmed by liver biopsy within 6 months of Day -7.
•MRI-PDFF performed at screening with ≥ 8% steatosis.

Exclusion criteria

•Subjects with a history of active or chronic liver disease, including alcoholic liver disease, viral hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, Wilson's disease, hemochromatosis, alpha-1 antitrypsin deficiency, human immunodeficiency virus (HIV).
•Any history of clinically significant chronic liver disease including esophageal varices, ascites, hepatic encephalopathy, splenomegaly, or any hospitalization for treatment of chronic liver disease; or Model for End Stage Liver Disease >12.
•Recent (within 3 months of baseline biopsy) use of therapies associated with development of NAFLD (e.g., systemic corticosteroids, methotrexate, tamoxifen, aromatase inhibitors, amiodarone, or long-term use of tetracyclines).
•Type 1 diabetes subjects, or T2DM subjects on GLP-1 receptor agonist therapy, or other therapies not allowed for this study

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

MASH / liver

1 endpoint
Primary/protocol endpoint

pharmacodynamic (PD) effect of HM15211

Time frame:12 months

MASH resolution, no fibrosis worsening

categorical status, improvement

SNOMED 442685003

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.