CLINICAL PROTOCOL to Investigate the Long-term Safety and Efficacy of Metreleptin in Various Forms of Partial Lipodystrophy

Model scores of the 29,894 trials active now.

Model score 22% for any early termination, 10% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 26% of the time (136 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2019-11-14. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: abledefinedprotocolinsulinsafety and
  Phrases that lowered it: efficacythe followingboneliverpreviously
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 10.2% (raises risk) · Sponsor's track record
• Phase: 2 (raises risk) · Design
• Design: single group (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 101 (lowers risk) · Sponsor's track record
• Drug's FAERS reports with a death: 5.6% (lowers risk) · Drug's FDA history
• Disease area, cancer: No (lowers risk) · Disease area
• Sponsor type: academic or other (raises risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Sponsor's past trials: 284 (lowers risk) · Sponsor's track record
• Disease area, dermatology: Yes (raises risk) · Disease area
• Drug's FAERS reports marked serious: 80.6% (lowers risk) · Drug's FDA history
• Number of arms: 1 (raises risk) · Design
• Minimum age: 5 (lowers risk) · Who can join
• Responsible party: principal investigator (lowers risk) · Design
• Collaborators: 0 (raises risk) · Design

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

• Clinical Protocol to Investigate the Efficacy of Recombinant Human Leptin (Metreleptin) in Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) Associated With Lipodystrophy NCT01679197 · started 2012 · scored riskier than 53% of active trials completed
• A Study of the Safety of Mibavademab in Pediatric and Adult Participants Switching From Metreleptin to Mibavademab for the Treatment of Generalized Lipodystrophy (GLD) NCT06548100 · started 2024 · scored riskier than 78% of active trials completed
• Effects of Metreleptin in Type 1 Diabetes Mellitus NCT01268644 · started 2010 · scored riskier than 25% of active trials terminated
• Setmelanotide for the Treatment of Leptin Receptor (LEPR) Deficiency Obesity NCT03287960 · started 2018 · scored riskier than 24% of active trials completed
• Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy NCT04159415 · started 2020 · scored riskier than 21% of active trials completed

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.