Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.

NCT02229851 on ClinicalTrials.gov Phase 3 Novo Nordisk A/S (industry) Started 2014-10-31 Completed

Riskier than 19% of active trials

Model scores of the 29,894 trials active now.

Model score 11% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 15% of the time (734 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 2018-05-07, after 2014-10-31 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 2018-05-07. 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: 6.1% (lowers risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: placebongcarcinoma ofsubjects withcell
Phrases that lowered it: openinsulinto comparekgbmi
Minimum age: 23 (lowers risk) · Who can join
Phase: 3 (lowers risk) · Design
Disease area, neurology: Yes (raises risk) · Disease area
Design: parallel (raises risk) · Design
Trials the sponsor started in the prior 2 years: 89 (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 11.4% (lowers risk) · Drug's FDA history
Maximum age: 79 (raises risk) · Who can join
Sponsor type: industry (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Blinding: double (raises risk) · Design
Drug's FAERS reports marked serious: 91.4% (raises risk) · Drug's FDA history
Has a data monitoring committee: No (lowers risk) · Design
Sponsor's past trials: 524 (raises risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Number of arms: 3 (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: 3 (typical: 2)
Number of arms: 3 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: double (typical: 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: 23 (typical: 18)
Maximum age: 79 (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: 524 (typical: 32)
Sponsor's past termination rate: 6.1% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 89 (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: 3072 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 904 (typical: 412.5)
Drug's FAERS reports marked serious: 91.4% (typical: 85.6%)
Drug's FAERS reports with a death: 11.4% (typical: 15.9%)

Disease area and drugs

Disease areas: neurology, musculoskeletal, endocrine
Drugs matched to FDA substances: somapacitan, somatropin

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 Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency NCT01973244 · started 2013 · scored riskier than 9% of active trials completed
A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency NCT03075644 · started 2017 · scored riskier than 22% of active trials completed
A Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency NCT02382939 · started 2015 · scored riskier than 15% of active trials completed
Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency NCT02616562 · started 2016 · scored riskier than 35% of active trials completed
A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency NCT01706783 · started 2012 · scored riskier than 9% 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.