A Study of the Effect of Dulaglutide on How the Body Handles Oral Contraceptive in Healthy Female Participants

NCT01458210 on ClinicalTrials.gov Phase 1 Eli Lilly and Company (industry) Started 2011-10-31 Completed

Riskier than 3% of active trials

Model scores of the 29,894 trials active now.

Model score 4% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 6% of the time (816 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 2012-02-29, after 2011-10-31 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 2012-02-29. 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: surgerycancerprioracuteassociated
Phrases that lowered it: healthytabletparticipantseffect ofhistory or
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Phase: 1 (lowers risk) · Design
Sponsor's past termination rate: 5.3% (lowers risk) · Sponsor's track record
Design: single group (raises risk) · Design
Drug's FAERS reports with a death: 15.3% (lowers risk) · Drug's FDA history
Sponsor type: industry (lowers risk) · Sponsor's track record
Sponsor's past trials: 601 (raises risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Primary purpose: treatment (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Disease area, neurology: No (lowers risk) · Disease area
Minimum age: 18 (raises risk) · Who can join
Blinding: none (lowers risk) · Design
Maximum age: 45 (lowers risk) · Who can join

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 (typical: 2)
Number of arms: 1 (typical: 2)
Allocation: not applicable (typical: randomized)
Design: single group (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 45 (typical: 71)
Sex: female (typical: all)
Accepts healthy volunteers: Yes (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 601 (typical: 32)
Sponsor's past termination rate: 5.3% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 208 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 2 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 1631 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 336 (typical: 412.5)
Drug's FAERS reports marked serious: 88.5% (typical: 85.6%)
Drug's FAERS reports with a death: 15.3% (typical: 15.9%)

Disease area and drugs

Disease areas: metabolic, endocrine
Drugs matched to FDA substances: dulaglutide, moxifloxacin

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

A Study of the Effect of Dulaglutide on How Body Handles Digoxin in Healthy Participants NCT01436201 · started 2011 · scored riskier than 4% of active trials completed
A Study to Compare the Effect of Giving Dulaglutide Using an Auto-injector Versus a Manual Syringe NCT01524770 · started 2012 · scored riskier than 0% of active trials completed
A Study of LY2216684 in Healthy Females NCT01373931 · started 2011 · scored riskier than 2% of active trials completed
A Study of the Effect of Dulaglutide on the Action of Warfarin in Healthy Participants NCT01432938 · started 2011 · scored riskier than 2% of active trials completed
LY2189265 and Atorvastatin Interaction Study NCT01250834 · started 2010 · scored riskier than 2% 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.