Trial to Learn About the Study Medicine (PF-07081532) and Rybelsus in People With Type 2 Diabetes and Separately PF-07081532 in People With Obesity

NCT05579977 on ClinicalTrials.gov Phase 2 Pfizer (industry) Started 2022-10-27 Terminated

Riskier than 38% of active trials

Model scores of the 29,894 trials active now.

Model score 14% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 11% of the time (493 trials).

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

How it ended

Terminated on 2023-09-22, after 2022-10-27 start.

Reason given by the sponsor: “other”

The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.

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 2023-09-22. 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

Sponsor's past termination rate: 15.8% (raises risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: pfulnmg dlegfractive
Phrases that lowered it: kgbmim2drugand safety
Sponsor's past trials: 2104 (raises risk) · Sponsor's track record
Phase: 2 (raises risk) · Design
Drug's FAERS reports marked serious: 42.6% (lowers risk) · Drug's FDA history
Has a data monitoring committee: Yes (raises risk) · Design
Blinding: quadruple (lowers risk) · Design
Drug's FAERS reports with a death: 1.5% (lowers risk) · Drug's FDA history
Design: parallel (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Number of arms: 13 (lowers risk) · Design
Primary purpose: treatment (raises risk) · Design
Trials the sponsor started in the prior 2 years: 190 (lowers risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Maximum age: 75 (raises risk) · Who can join
Minimum age: 18 (raises risk) · Who can join
Disease area, neurology: No (lowers risk) · Disease area
Disease area, metabolic: Yes (lowers risk) · Disease area
Drug's FAERS reports in the prior 12 months: 8157 (lowers risk) · Drug's FDA history

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: 2
Number of arms: 13 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: quadruple (typical: none)
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 2 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 75 (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 2104 (typical: 32)
Sponsor's past termination rate: 15.8% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 190 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 1
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 19391 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 8157 (typical: 412.5)
Drug's FAERS reports marked serious: 42.6% (typical: 85.6%)
Drug's FAERS reports with a death: 1.5% (typical: 15.9%)

Disease area and drugs

Disease areas: metabolic, endocrine
Drugs matched to FDA substances: semaglutide

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

Study of Multiple Oral Doses of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus NCT05158244 · started 2021 · scored riskier than 49% of active trials completed
A 12-week Study To Evaluate PF-06291874 Once a Day in Adults With T2DM Inadequately Controlled On Metformin NCT02554877 · started 2015 · scored riskier than 69% of active trials completed
A Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Obesity NCT04707313 · started 2021 · scored riskier than 81% of active trials completed
Effects of Roflumilast on Insulin and Blood Sugar Levels in Prediabetic Overweight and Obese Individuals NCT01862029 · started 2013 · scored riskier than 10% of active trials completed
Study of MEDI0382 in Combination With Dapagliflozin and Metformin in Overweight/Obese Participants With Type 2 Diabetes NCT03444584 · started 2018 · scored riskier than 20% 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.