indication directory

MASH / NASH clinical trial intelligence

Trials are included only when the source condition or controlled indication mapping directly matches this disease area. Full protocol, result, eligibility and IP analysis is available inside the premium workspace.

Validated reports

Directory type

indication

Association rule

source condition

NCT05083390

Source recordAI-normalized

Double-blind, Randomised, Placebo-controlled, Phase IIb Trial on the Efficacy and Safety of Norursodeoxycholic Acid Tablets in Patients With Non-alcoholic Steatohepatitis (NASH)

Dr. Falk Pharma GmbH is advancing norUDCA as a potential treatment for NASH, a condition with significant unmet medical need and a growing patient population. The Phase 2b trial aims to establish the efficacy and safety of norUDCA compared to placebo, with two dosing regimens (1000 mg/d and 1500 mg/d). If successful, this could position norUDCA favorably in a competitive landscape that includes other emerging therapies for NASH, such as obeticholic acid and elafibranor. The trial's outcomes may influence future partnerships or acquisition interest, particularly given the increasing focus on liver diseases in the biopharmaceutical sector.

AI analysis

Indication: Nonalcoholic Steatohepatitis

Modality: small molecule

Target: Norursodeoxycholic Acid (norUDCA) is a bile acid derivative that may modulate liver metabolism and inflammation, targeting pathways involved in non-alcoholic steatohepatitis (NASH) pathology.

Sponsor: Dr. Falk Pharma GmbH

Source URL: ClinicalTrials.gov

Source updated: Feb 20, 2024

Ingested: Jun 09, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by conditions: Nonalcoholic Steatohepatitis

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Condition raw: Nonalcoholic Steatohepatitis

Condition normalized: Nonalcoholic Steatohepatitis

Modality raw: small molecule

Modality normalized: small molecule

Target raw: Norursodeoxycholic Acid (norUDCA) is a bile acid derivative that may modulate liver metabolism and inflammation, targeting pathways involved in non-alcoholic steatohepatitis (NASH) pathology.

Target normalized: Norursodeoxycholic Acid (norUDCA) is a bile acid derivative that may modulate liver metabolism and inflammation, targeting pathways involved in non-alcoholic steatohepatitis (NASH) pathology.

Open report

NCT07466017

Source recordAI-normalized

A Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Study to Evaluate the Efficacy and Safety of CS060380 Tablets in Patients With Metabolic Dysfunction-associated Steatohepatitis (MASH) and Obesity.

Cascade Pharmaceuticals, Inc. is advancing CS060380 in a Phase II trial to evaluate its efficacy and safety in combination with semaglutide for treating MASH and obesity. The market for obesity and related liver diseases is significant, with increasing prevalence globally. The combination therapy approach may provide a competitive edge against existing treatments, particularly as semaglutide has shown promise in weight management. Successful trial outcomes could position Cascade favorably in a growing market, but diligence is required regarding regulatory pathways and potential competition from other obesity and liver disease therapies.

AI analysis

Indication: Metabolic Dysfunction-associated Steatohepatitis (MASH)

Modality: small molecule

Target: CS060380 is a THR-beta agonist targeting metabolic dysfunction-associated steatohepatitis (MASH) and obesity.

Sponsor: Cascade Pharmaceuticals, Inc

Source URL: ClinicalTrials.gov

Source updated: May 20, 2026

Ingested: Jun 09, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by conditions: Metabolic Dysfunction-associated Steatohepatitis (MASH)

View original source fields

Condition raw: Metabolic Dysfunction-associated Steatohepatitis (MASH), Obesity

Condition normalized: Metabolic Dysfunction-associated Steatohepatitis (MASH), Obesity

Modality raw: small molecule

Modality normalized: small molecule

Target raw: CS060380 is a THR-beta agonist targeting metabolic dysfunction-associated steatohepatitis (MASH) and obesity.

Target normalized: CS060380 is a THR-beta agonist targeting metabolic dysfunction-associated steatohepatitis (MASH) and obesity.

Open report

NCT06465186

Source recordAI-normalized

Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Adults With Compensated Cirrhosis Secondary to Metabolic Dysfunction-Associated Steatohepatitis

Efinopegdutide is being developed by Merck Sharp & Dohme LLC for the treatment of compensated cirrhosis secondary to MASH, a condition with significant unmet medical need and increasing prevalence due to rising obesity and diabetes rates. The global market for therapies targeting liver diseases, particularly NASH/MASH, is projected to grow substantially, with numerous competitors also in development. Successful outcomes from this trial could position Merck favorably in a competitive landscape, potentially leading to a first-in-class designation if efinopegdutide demonstrates superior efficacy and safety. Diligence should focus on the regulatory pathway, potential market access challenges, and the evolving competitive landscape as other candidates progress through clinical trials.

AI analysis

Indication: Non-alcoholic Fatty Liver Disease

Modality: combination therapy

Target: Efinopegdutide (MK-6024) targets metabolic dysfunction-associated steatohepatitis (MASH) by potentially reducing liver fat, inflammation, and fibrosis.

Sponsor: Merck Sharp & Dohme LLC

Source URL: ClinicalTrials.gov

Source updated: Mar 02, 2026

Ingested: Jun 09, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by conditions: Nonalcoholic Steatohepatitis

View original source fields

Condition raw: Non-alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis, NAFLD, Metabolic Dysfunction-associated Steatotic Liver Disease, Metabolic Dysfunction-associated Steatohepatitis

Condition normalized: Non-alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis, NAFLD, Metabolic Dysfunction-associated Steatotic Liver Disease, Metabolic Dysfunction-associated Steatohepatitis

Modality raw: combination therapy

Modality normalized: combination therapy

Target raw: Efinopegdutide (MK-6024) targets metabolic dysfunction-associated steatohepatitis (MASH) by potentially reducing liver fat, inflammation, and fibrosis.

Target normalized: Efinopegdutide (MK-6024) targets metabolic dysfunction-associated steatohepatitis (MASH) by potentially reducing liver fat, inflammation, and fibrosis.

Open report

NCT06318169

Source recordAI-normalized

A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis is a PHASE3 clinical asset sponsored by 89bio, Inc. in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis. SEO and diligence focus: Pegozafermin, Placebo, endpoint relevance, enrollment feasibility, competitive positioning, readout timing and IP durability.

AI analysis

Indication: Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis

Modality: protein therapy

Target: Pegozafermin, Placebo

Sponsor: 89bio, Inc.

Source URL: ClinicalTrials.gov

Source updated: Jun 04, 2026

Ingested: May 23, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis

View original source fields

Condition raw: Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis

Condition normalized: Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis

Modality raw: protein therapy

Modality normalized: protein therapy

Target raw: Pegozafermin, Placebo

Target normalized: Pegozafermin, Placebo

Open report