Autopsy report · NCT02179151

Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Beloranib) in Obese Subjects With Prader-Willi Syndrome

“FDA Clinical Hold”

The sponsor’s own words in the registry.

Life of this trial

• Registered 3 months before it started.
• Ran for about 2 years 1 month before it stopped.
• 108 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Zafgen, Inc.

Sponsor type

Industry

Conditions

Prader-Willi Syndrome; Obesity

Interventions

ZGN-440 for Injectable Suspension; ZGN-440 Placebo for Injectable Suspension

Participants

108

Sites

15

Countries

United States

Trials that died the same way

• A Phase I/II Study of BI-505 in Conjunction With Autologous Stem Cell Transplant in Multiple Myeloma
  “Full clinical hold from FDA” (95% match in meaning)
• DB289 Versus TMP-SMX for the Treatment of Acute Pneumocystis Jiroveci Pneumonia (PCP)
  “FDA Clinical Hold as of 12/21/07 due to safety concerns” (88% match in meaning)
• Safety of SP-420 in the Treatment of Transfusional Iron Overload
  “Study is on hold by FDA in the US.” (77% match in meaning)
• MAS-1 Adjuvanted Compared to Unadjuvanted Influenza Vaccines in the Elderly
  “FDA hold on the project” (74% match in meaning)
• AZD1222 Vaccine for the Prevention of COVID-19
  “The study was put on hold in September 2020 due to a safety concern in another trial but never restarted. In the meantime our clinical development program now includes a similar study with a different design, which we prefer to complete now.” (69% 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.