Trial of Leptin Administration After Roux-en-Y Gastric Bypass
Model scores of the 29,894 trials active now.
Model score 8% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 12% of the time (56 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2014-07-31, after 2008-04-30 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2014-07-31. 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.
What moved the score
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: surgerytimesbypasstissuewomen
Phrases that lowered it: bodybmiindividualskgday -
Design: crossover (lowers risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 8.7% (raises risk) · Sponsor's track record
-
Phase: 1/2 (raises risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Collaborators: 3 (lowers risk) · Design
-
Minimum age: 25 (lowers risk) · Who can join
-
Trials the sponsor started in the prior 2 years: 35 (lowers risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Blinding: triple (raises risk) · Design
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
-
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
-
Sponsor's past trials: 23 (lowers risk) · Sponsor's track record
-
Responsible party: principal investigator (lowers 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.
The trial
Design
- Phase
- 1/2 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 3 (typical: 0)
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 25 (typical: 18)
- Maximum age
- 65 (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 23 (typical: 32)
- Sponsor's past termination rate
- 8.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 35 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic
- Drugs matched to FDA substances
- metreleptin
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Effect of GLP-1 Receptor Agonism After Sleeve Gastrectomy NCT03115424 · started 2017 · scored riskier than 8% of active trials completed
- Ghrelin and Insulin Resistance NCT00884494 · started 2011 · scored riskier than 11% of active trials completed
- Leptin in the Maintenance of Reduced Body Weight NCT01155180 · started 2008 · scored riskier than 20% of active trials completed
- Pharmacological and Behavioral Treatment After Bariatric Surgery: Acute (Stage 1) NCT04599478 · started 2021 · scored riskier than 44% of active trials completed
- Adjunct Phentermine + Topiramate After Bariatric Surgery in 12-24 Year Olds NCT04095104 · started 2020 · scored riskier than 46% 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.