Autopsy report · NCT03097107

Evaluate the Safety and Efficacy of Saroglitazar Mg in Patients With Fasting Triglyceride ≥500 mg/dL and ≤1500 mg/dL

“Management decision to suspend the study due to recruitment issues”

The sponsor’s own words in the registry.

Life of this trial

• Suspended: paused, and may or may not restart.
• 124 participants planned (an estimate, not an actual count).

Vital statistics

Status

Suspended

Phase

Phase 2

Sponsor

Zydus Therapeutics Inc.

Sponsor type

Industry

Conditions

Dyslipidemias

Interventions

Saroglitazar Magnesium 1 mg; Saroglitazar Magnesium 2 mg; Saroglitazar Magnesium 4 mg; Placebo

Participants

124 (planned, not actual)

Sites

33

Countries

United States

Trials that died the same way

• Efficacy of Educating Physical Therapists in the Treatment of Patients With Nonspecific Chronic Low Back Pain
  “We had many issues related to recruitment. After many attempts we want to suspend the study with 13 patients.” (83% match in meaning)
• Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome
  “The study was terminated due to recruitment challenges” (76% match in meaning)
• Early Versus Late Amniotomy Following EAB Cervical Ripening
  “Study was terminated due to difficulties in recruitment” (75% match in meaning)
• Exercise to Prevent Aromatase Inhibitor Side Effects in Breast Cancer Patients
  “The study was stopped due to recruitment difficulties” (74% match in meaning)
• DELPhI Evaluation of Psychiatric Conditions
  “Study was withdrawn due to recruitment difficulties” (74% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.