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A Randomized, Double-blind, Parallel-group, Placebo-controlled, Exploratory Study of DSP-1747 in Patients with Nonalcoholic Steatohepatitis

A Randomized, Double-blind, Parallel-group, Placebo-controlled, Exploratory Study of DSP-1747 in Patients with Nonalcoholic Steatohepatitis(Phase 2 Study)

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221948
Enrollment
200
Registered
2012-10-25
Start date
2012-10-25
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonalcoholic Steatohepatitis

Interventions

investigational material(s) Generic name etc : DSP-1747 INN of investigational material : Obeticholic acid Therapeutic category code : 391 Agents for liver disease Dosage and Administration for Inves

Sponsors

Sumitomo Dainippon Pharma Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Patients with Nonalcoholic Steatohepatitis based on the liver biopsy -Outpatients etc.

Exclusion criteria

Exclusion criteria: - Patients with significant alcohol consumption - Patients with complication by other chronic liver disease etc.

Design outcomes

Primary

MeasureTime frame
Histological improvement Last observation

Secondary

MeasureTime frame
Change in indicators of hepatic function Change in disease markers Last observation

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026