What WAYFIND measured first
| SEMA + CILO/FIR FDCn=124 | PTM SEMA + PTM CILO/FIRn=84 |
|---|---|
| 13.7(8.2 to 21.0) | 8.3(3.4 to 16.4) |
A Phase 2, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study Evaluating the Safety and Efficacy of Semaglutide, and the Fixed-Dose Combination of Cilofexor and Firsocostat, Alone and in Combination, in Subjects With Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)
Percentage of Participants Who Achieved ≥ 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 72 in Semaglutide (SEMA) + Cilofexor/Firsocostat (CILO/FIR) Fixed Dose Combination (FDC) Versus Placebo Groups (percentage of participants), Week 72. SEMA + CILO/FIR FDC: 13.7; PTM SEMA + PTM CILO/FIR: 8.3.
As posted on ClinicalTrials.gov (NCT04971785), updated at source Nov 26, 2025. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
| SEMA + CILO/FIR FDCn=124 | PTM SEMA + PTM CILO/FIRn=84 |
|---|---|
| 13.7(8.2 to 21.0) | 8.3(3.4 to 16.4) |
Percent of participants affected, All-cause mortality and Adverse events: Up to 72 weeks plus 35 days. The most common events the registry lists.
| Event | SEMA + CILO/FIR FDC | SEMA + PTM CILO/FIR | PTM SEMA + CILO/FIR FDC | PTM SEMA + PTM CILO/FIR |
|---|---|---|---|---|
| Any serious event | 13.7% | 10.7% | 14.6% | 13.1% |
| Nausea | 47.6% | 40.2% | 23.6% | 22.6% |
| Diarrhoea | 27.4% | 20.5% | 13% | 17.9% |
| Constipation | 24.2% | 21.3% | 8.9% | 8.3% |
| Vomiting | 21.8% | 17.2% | 5.7% | 7.1% |
| Covid-19 | 16.9% | 12.3% | 12.2% | 16.7% |
| Decreased appetite | 15.3% | 16.4% | 5.7% | 6% |
| Fatigue | 13.7% | 13.9% | 7.3% | 13.1% |
| Abdominal pain | 8.9% | 8.2% | 4.9% | 13.1% |
| Arthralgia | 6.5% | 4.9% | 9.8% | 13.1% |
| Hypoglycaemia | 11.3% | 3.3% | 2.4% | 6% |
| Gastrooesophageal reflux disease | 5.6% | 10.7% | 2.4% | 2.4% |
| Pruritus | 6.5% | 10.7% | 9.8% | 7.1% |
| Urinary tract infection | 10.5% | 4.9% | 6.5% | 3.6% |
| Upper respiratory tract infection | 5.6% | 3.3% | 9.8% | 4.8% |
| Headache | 5.6% | 9% | 9.8% | 3.6% |
| Dyspepsia | 9.7% | 1.6% | 3.3% | 3.6% |
| Abdominal pain upper | 5.6% | 9% | 4.9% | 9.5% |
| Dizziness | 5.6% | 8.2% | 7.3% | 9.5% |
| Back pain | 6.5% | 5.7% | 6.5% | 8.3% |
| Cough | 2.4% | 2.5% | 5.7% | 8.3% |
| Abdominal distension | 7.3% | 8.2% | 3.3% | 7.1% |
| Sinusitis | 6.5% | 6.6% | 3.3% | 7.1% |
| Hypertension | 2.4% | 0.8% | 2.4% | 7.1% |
| Bronchitis | 1.6% | 2.5% | 4.1% | 6% |
| Influenza | 0.8% | 1.6% | 2.4% | 6% |
| SEMA + CILO/FIR FDCn=124 | SEMA + PTM CILO/FIRn=122 |
|---|---|
| 13.7(8.2 to 21.0) | 15.6(9.6 to 23.2) |
| SEMA + CILO/FIR FDCn=82 | PTM SEMA + PTM CILO/FIRn=49 |
|---|---|
| 57.3(45.9 to 68.2) | 22.4(11.8 to 36.6) |
| SEMA + CILO/FIR FDCn=82 | PTM SEMA + CILO/FIR FDCn=88 |
|---|---|
| 57.3(45.9 to 68.2) | 31.8(22.3 to 42.6) |
The goal of this clinical study is to understand whether the study drugs, semaglutide (SEMA) with the fixed-dose combination (FDC) of cilofexor/firsocostat (CILO/FIR), cause fibrosis improvement and Nonalcoholic Steatohepatitis (NASH) resolution in participants with cirrhosis due to NASH.
Key Inclusion Criteria: * Liver biopsy consistent with cirrhosis (F4) due to nonalcoholic steatohepatitis (NASH) in the opinion of the central reader. In individuals who have never had a liver biopsy, a screening liver biopsy may be performed. * Screening laboratory parameters as determined by the study central laboratory: * Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m\^2, as calculated by the Modification of Diet in Renal Disease (MDRD) equation. * Hemoglobin A1c (HbA1c) ≤ 10% * International normalized ratio (INR) ≤ 1.4, unless due to therapeutic anticoagulation * Platelet count ≥ 125,000/µL * Alanine aminotransferase (ALT) \< 5 x upper limit of normal (ULN) * Serum albumin ≥ 3.5 g/dL * Serum alkaline phosphatase (ALP) ≤ 2 x ULN * Body mass index (BMI) ≥ 23 kg/m\^2 at screening. Key Exclusion Criteria: * Prior history of decompensated liver disease, including ascites, hepatic encephalopathy (HE), or variceal bleeding. * Child-Pugh (CP) score \> 6 at screening, unless due to an alternative etiology such as Gilbert's syndrome or therapeutic anticoagulation. * Model for End-stage Liver Disease (MELD) score \> 12 at screening, unless due to an alternative etiology such as therapeutic anticoagulation. * Other causes of liver disease based on medical history and/or central reader review of liver histology, including but not limited to: alcoholic liver disease, autoimmune disorders (eg, primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency. * Chronic hepatitis B virus (HBV) infection (HBsAg positive), or Chronic hepatitis C virus (HCV) infection (HCV antibody and HCV ribonucleic acid (RNA) positive). Individuals cured of HCV infection less than 2 years prior to the screening visit are not eligible. * History of liver transplantation. * Current or prior history of hepatocellular carcinoma (HCC). * Men who habitually drink greater than 21 units/week of alcohol or women who habitually drink greater than 14 units/week of alcohol (1 unit is equivalent to 12 ounce (oz)/360 mL of beer, a 4 oz/120 mL glass of wine, or 1 oz/30 mL of hard liquor). * For individuals on vitamin E regimen ≥ 800 IU/day, or pioglitazone, dose must be stable, in the opinion of the investigator for at least 180 days prior to the historical or screening liver biopsy. * For individuals on medications for diabetes, dose must be stable, in the opinion of the investigator, for at least 90 days prior to the historical or screening liver biopsy. * History of type 1 diabetes. * Treatment with a glucagon-like peptide-1 receptor agonist (GLP-1 RA) in the period from 90 days prior to the screening visit and for individuals with a qualifying historical liver biopsy, for 90 days prior to the date of the historical liver biopsy. * For individuals who have not completed a series of an authorized coronavirus...
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.