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NCT05083390UNKNOWNanonymous

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

Sponsor

Source record

Dr. Falk Pharma GmbH

Phase

Source record

Phase 2b

Modality

AI-normalized

small molecule

Target

AI-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.

Indication / condition

AI-normalized

Nonalcoholic Steatohepatitis

Intervention

Source record

norUrsodeoxycholic acid

Source & freshness

Source record

NCT ID

NCT05083390

Original source

ClinicalTrials.gov

Source last updated

Feb 20, 2024

Ingested at

Jun 09, 2026

Internal sync

Jun 09, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT05083390

Title

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

Sponsor

Dr. Falk Pharma GmbH

Status

UNKNOWN

Phase

Phase 2b

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.

Interventions

norUrsodeoxycholic acid

Public preview

Source record

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-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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TrialSignal

Clinical trial intelligence report

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

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 13, 2026

NCT ID

NCT05083390

Status

UNKNOWN

Phase

Phase 2b

Sponsor

Dr. Falk Pharma GmbH

Executive brief

Investment-Ready Snapshot

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.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedFeb 20, 2024
Internal syncJun 09, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT05083390

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.

Intervention

norUrsodeoxycholic acid

Source record

Protocol Description

Detailed source ingestion pending.

Source record

Outcome Measures

Detailed source ingestion pending.

Source record

Eligibility

Detailed source ingestion pending.

AI analysis

Known Results And Readout Context

Detailed source ingestion pending.

IP intelligence

Patent And IP Landscape

Detailed source ingestion pending.

Source record

Contacts

Detailed source ingestion pending.