GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2Results posted

Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Participants With Nonalcoholic Steatohepatitis (NASH)

A Proof of Concept, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Subjects With Nonalcoholic Steatohepatitis (NASH)

Lead sponsor

Gilead Sciences

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

109

actual

Study population

MASH / NAFLD / liver fibrosis

Key I/E criteria

•BMI ≥23•HbA1c ≤9.5%•eGFR ≥30

Primary endpoints

•Treatment-emergent AEs (any)•Treatment-Emergent Laboratory Abnormalities

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 IDNCT03987074

Org study IDGS-US-454-5533

Timeline

Milestones

Study first posted2019-06-14actual

Study start2019-07-29actual

Primary completion2020-07-13actual

Study completion2020-07-13actual

Last update posted2021-07-15actual

Results first posted2021-07-15actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

MASH / NAFLD / liver fibrosis

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Eligibility criteria

Key Inclusion Criteria:

•Historical liver biopsy consistent with NASH with stage 2-3 fibrosis according to NASH Clinical Research Network (CRN) classification OR clinical diagnosis of nonalcoholic fatty liver disease and screening FibroTest, magnetic resonance imaging - proton density fat fraction (MRI-PDFF), and FibroScan

•Screening laboratory parameters, as determined by central laboratory:

–Alanine aminotransferase (ALT) ≤ 5 x upper limit of the normal range (ULN)

–Estimated glomerular filtration rate (eGFR) ≥ 30 milliliter/minute (mL/min), as calculated by the Modification of Diet in Renal Disease (MDRD) study equation

–HbA1c ≤ 9.5%

–International normalized ratio (INR) ≤ 1.2, unless due to therapeutic anti-coagulation therapy

–Platelet count ≥ 100,000/μL

–Total bilirubin < 1.3 x ULN unless alternate etiology such as Gilbert's syndrome present

–Calcitonin ≤ 100 ng/L

•Body Mass Index (BMI) > 23 kg/m^2 and body weight of > 60 kg

Key Exclusion Criteria:

•Any historical liver biopsy consistent with cirrhosis

•Any history of decompensated liver disease, including ascites, hepatic encephalopathy, or variceal bleeding

•Other causes of liver disease, including but not limited to: alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders (eg, primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency requiring treatment

•History of liver transplantation

•History of hepatocellular carcinoma

•History of pancreatitis (acute or chronic)

•Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma

•Treatment with glucagon-like peptide-1 receptor agonists (GLP-1 RA) in the period from 90 days prior to the date of the Screening Visit

•Individuals on antidiabetic medications must be on a stable dose for at least 90 days prior to the date of the Screening Visit and in the period between the date of the Screening Visit and Enrollment (Day -14)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Endpoints (4)

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.

Safety / tolerability / PK

4 endpoints

Primary/registry result

Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)

Time frame:First dose date up to Week 24 plus 30 days

Treatment-emergent AEs (any)

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
Semaglutide	81.0	—
Semaglutide + Firsocostat 20 mg	86.4	—
Semaglutide + Cilofexor 30 mg	81.8	—
Semaglutide + Cilofexor 100 mg	72.7	—
Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg	90.5	—

Primary/registry result

Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities

Time frame:First dose date up to 24 weeks plus 30 days

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
SemaglutideGrade 1	61.9	—
Grade 2	23.8	—
Grade 3	0.0	—
Grade 4	0.0	—
Semaglutide + Firsocostat 20 mgGrade 1	63.6	—
Grade 2	22.7	—
Grade 3	4.5	—
Grade 4	0.0	—
Semaglutide + Cilofexor 30 mgGrade 1	36.4	—
Grade 2	31.8	—
Grade 3	0.0	—
Grade 4	0.0	—
Semaglutide + Cilofexor 100 mgGrade 1	50.0	—
Grade 2	18.2	—
Grade 3	0.0	—
Grade 4	9.1	—
Semaglutide + Firsocostat 20 mg + Cilofexor 30 mgGrade 1	66.7	—
Grade 2	9.5	—
Grade 3	0.0	—
Grade 4	0.0	—

Primary/protocol endpoint

Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)

Time frame:First dose date up to Week 24 plus 30 days

Treatment-emergent AEs (any)

threshold achievement, event

Primary/protocol endpoint

Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities

Time frame:First dose date up to 24 weeks plus 30 days

threshold achievement, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Safety and efficacy of combination therapy with semaglutide, cilofexor and firsocostat in patients with non-alcoholic steatohepatitis: A randomised, open-label phase II trial.
Journal of hepatology2022 Sep (month)PMID35439567doi:10.1016/j.jhep.2022.04.003via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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.