Report workspace

Add to folder
NCT03863574COMPLETEDanonymous

A Phase 2, Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Saroglitazar Magnesium 2 mg and 4 mg in Patients With Non-alcoholic Steatohepatitis (NASH)

Sponsor

Source record

Zydus Therapeutics Inc.

Phase

Source record

Phase 2

Modality

AI-normalized

small molecule

Target

AI-normalized

Dual PPAR alpha/gamma agonist

Indication / condition

AI-normalized

Non Alcoholic Steatohepatitis

Intervention

Source record

Saroglitazar Magnesium 2mg, Saroglitazar Magnesium 4mg, Placebos

Source & freshness

Source record

NCT ID

NCT03863574

Original source

ClinicalTrials.gov

Source last updated

Oct 15, 2024

Ingested at

Jun 13, 2026

Internal sync

Jun 13, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT03863574

Title

A Phase 2, Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Saroglitazar Magnesium 2 mg and 4 mg in Patients With Non-alcoholic Steatohepatitis (NASH)

Sponsor

Zydus Therapeutics Inc.

Status

COMPLETED

Phase

Phase 2

Condition raw

Non Alcoholic Steatohepatitis

Condition normalized

Non Alcoholic Steatohepatitis

Modality raw

small molecule

Modality normalized

small molecule

Target raw

Dual PPAR alpha/gamma agonist

Target normalized

Dual PPAR alpha/gamma agonist

Interventions

Saroglitazar Magnesium 2mg, Saroglitazar Magnesium 4mg, Placebos

Public preview

Source record

Saroglitazar Magnesium is being evaluated for its efficacy in treating Non-alcoholic Steatohepatitis (NASH), a condition with increasing prevalence and limited treatment options. The market for NASH therapeutics is projected to grow significantly, driven by rising obesity rates and increasing awareness of liver diseases. Zydus Therapeutics Inc. is positioned to capture market share if Saroglitazar demonstrates superior efficacy and safety compared to existing therapies. Competitive landscape includes other investigational drugs targeting NASH, necessitating robust clinical data to differentiate Saroglitazar. Diligence should focus on regulatory pathways and potential market access strategies, particularly in regions with high NASH prevalence.

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

Report access

Create an account to unlock this report

Choose the access model that matches the job: one urgent report, reusable credits for project work, or unlimited monthly access with AI and folders.

Full protocol, outcomes, eligibility, contacts and results sections
Patent/IP landscape with verified records when available
Board-ready PDF export with source provenance
Save to folders and synthesize multiple assets in premium workspace
Create account

Create a free account first, then unlock a single report, buy credits or subscribe.