Study of Semaglutide, and Cilofexor/Firsocostat, Alone and in Combination, in Adults With Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)

Conditions

• Nonalcoholic Steatohepatitis

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Semaglutide (SEMA) — DRUG
  Administered as subcutaneous (SC) injection
• Cilofexor (CILO)/Firsocostat (FIR) — DRUG
  Tablets administered orally
• PTM SEMA — DRUG
  Administered as SC injection
• PTM CILO/FIR — DRUG
  Tablets administered orally

Study Details

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 Dates

Start date

Aug 9, 2021

Status verified

Nov 2025

Primary completion

Nov 12, 2024

Completion

Dec 9, 2024

Study Design

Enrollment

457 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: SEMA + CILO/FIR FDC
  Participants will receive semaglutide (SEMA) 3.0 mg/mL, once weekly and cilofexor and firsocostat (CILO/FIR) 30 mg/20 mg fixed-dose combination (FDC) tablet, once daily up to 72 weeks.
• Experimental: SEMA + PTM CILO/FIR
  Participants will receive SEMA 3.0 mg/mL, once weekly and Placebo-To-Match (PTM) CILO/FIR FDC tablet, once daily up to 72 weeks.
• Experimental: PTM SEMA + CILO/FIR FDC
  Participants will receive PTM SEMA, once weekly and CILO/FIR 30 mg/20 mg FDC tablet, once daily up to 72 weeks.
• Placebo Comparator: PTM SEMA + PTM CILO/FIR
  Participants will receive PTM SEMA, once weekly and PTM CILO/FIR FDC tablet, once daily up to 72 weeks.

Primary Outcome Measure

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 [ Time Frame: Week 72 ]

Locations (175)

Related coverage on Hipa.ai

• Semaglutide Combination Therapy Shows Significant NASH Resolution in Cirrhosis
  Semaglutide · Nov 26, 2025 · ClinicalTrials.gov

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