A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GZR4 in Subjects With Type 2 Diabetes

NCT06553248 on ClinicalTrials.gov Phase 1 Gan and Lee Pharmaceuticals, USA (industry) Started 2023-03-22 Completed

Riskier than 10% of active trials

Model scores of the 29,894 trials active now.

Model score 8% 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 in 2015 or later: the model never saw it during training.

How it ended

Completed on 2023-11-01, after 2023-03-22 start.

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 2023-11-01. 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: 0% (lowers risk) · Sponsor's track record
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: to screeningmonths priorprior towithin monthstrial is
Phrases that lowered it: type diabetesmellituswith typepharmacokineticsdrug
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 1 (lowers risk) · Design
Drug's FAERS reports marked serious: 51.9% (lowers risk) · Drug's FDA history
Drug's FAERS reports with a death: 4.7% (lowers risk) · Drug's FDA history
Design: parallel (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Has a data monitoring committee: No (lowers risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Maximum age: 65 (raises risk) · Who can join
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Number of arms: 2 (raises risk) · Design
Sponsor's past trials: 11 (lowers risk) · Sponsor's track record
Disease area, neurology: No (lowers risk) · Disease area
Blinding: none (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 (typical: 2)
Number of arms: 2
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 3 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 65 (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: 11 (typical: 32)
Sponsor's past termination rate: 0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 7 (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: 17988 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 2327 (typical: 412.5)
Drug's FAERS reports marked serious: 51.9% (typical: 85.6%)
Drug's FAERS reports with a death: 4.7% (typical: 15.9%)

Disease area and drugs

Disease areas: metabolic, endocrine
Drugs matched to FDA substances: insulin degludec

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 GZR18 Injection in Chinese Adult Patients With Type 2 Diabetes Mellitus (T2DM) NCT06256523 · started 2022 · scored riskier than 14% of active trials completed
A Trial Comparing Efficacy and Safety of GZR101 and IDegAsp in Insulin Naïve or Insulin Treated Subjects with T2DM NCT06199505 · started 2023 · scored riskier than 4% of active trials completed
A Trial Comparing the Efficacy and Safety of GZR4 Injection Versus Insulin Degludec in Subjects with Type 2 Diabetes Mellitus NCT06202079 · started 2023 · scored riskier than 8% of active trials completed
A Study of BGM0504 in Chinese Patients With Type 2 Diabetes NCT06974825 · started 2023 · scored riskier than 10% of active trials completed
A Study of LY3209590 in Chinese Participants With Type 2 Diabetes Mellitus NCT05596747 · started 2022 · scored riskier than 8% 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.