Autopsy report · NCT02916056

2-Year Extension Study of Azeliragon in Subjects With Alzheimer's Disease (STEADFAST Extension)

“Not due to safety but due to a lack of efficacy at the 5 mg azeliragon dose.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 4 months before it started.
• Ran for about 1 year 6 months before it stopped.
• 297 participants enrolled.
• Results were posted on the registry 3 years after it ended.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

vTv Therapeutics

Sponsor type

Industry

Conditions

Alzheimer's Disease

Interventions

Azeliragon 5mg

Participants

297

Sites

71

Countries

Canada, United States

Trials that died the same way

• Biomarker Qualification for Risk of Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease (AD) and Safety and Efficacy Evaluation of Pioglitazone in Delaying Its Onset
  “Lack of efficacy of the drug; no safety concern” (64% match in meaning)
• Combination Therapy of RMC-4630 and LY3214996 in Metastatic KRAS Mutant Cancers
  “Due to a lack of safety and efficacy.” (60% match in meaning)
• Study of ADI-PEG 20 or Placebo Plus Gem and Doc in Previously Treated Subjects With Leiomyosarcoma (ARGSARC)
  “Lack of Efficacy, no safety concern.” (59% match in meaning)
• Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Sapablursen (Formerly ISIS 702843, IONIS-TMPRSS6-LRx)
  “Favorable safety and tolerability were seen, but efficacy results in the mid-stage study did not meet Ionis' minimum target product profile to justify further development.” (57% match in meaning)
• Safety and Tolerability of ABM-1310 in Patients With Advanced Solid Tumors
  “Not related to safety concerns or lack of efficacy” (56% 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.