Trial · NCT04599465
A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Participants With Cystic Fibrosis (CF)
NCT04599465, Phase 3, Completed, Vertex Pharmaceuticals Incorporated; results first posted 2023-08-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Participants With Cystic Fibrosis (CF). Trials, record NCT04599465. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04599465
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Participants With Cystic Fibrosis (CF)
- NCT number
- NCT04599465
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 69 participants, actual
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Conditions
- Cystic Fibrosis
- Interventions
- ELX/TEZ/IVA, IVA
- First posted
- 2020-10-22
- Last updated
- 2023-08-03
- Other registries' IDs
- eudract:2020-003170-44
- Results first posted
- 2023-08-03
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in 2-hour Blood Glucose Levels Following an OGTT to the Average of Week 36 and Week 48 | Baseline, Week 36 and 48 | Baseline 2-hour post-OGTT blood glucose level was defined as the average of valid pre-dose measurements at screening and Day 1. OGTT results were considered valid only when the participant was fasting for at least 8 hours. |
| Secondary | Percentage of Participants With Improvement in Dysglycemia Categorization at Week 48 | Baseline, Week 48 | Baseline dysglycemia category was defined as the most recent non-missing measurement before the first dose of study drug in the treatment period. Improvement in dysglycemia is a change from cystic fibrosis-related diabetes (CFRD) at baseline to impaired glucose tolerance (IGT)/normal glucose tolerance (NGT) at Week 48 OR change from IGT at baseline to NGT at Week 48. CFRD: 2-hour post-OGTT blood glucose level ≥200 mg/dL or fasting blood glucose level ≥126 mg/dL; IGT: 2-hour post-OGTT blood glucose level ≥140 to \<200 mg/dL and fasting blood glucose level \<126 mg/dL; NGT: 2 hour post-OGTT blood glucose level \<140 mg/dL and fasting blood glucose level \<126 mg/dL. |
| Secondary | Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Day 1 up to Week 52 |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in 2-hour Blood Glucose Levels Following an OGTT to the Average of Week 36 and Week 48 | Baseline, Week 36 and 48 | The Full Analysis Set (FAS) will include all enrolled participants who carry the intended CFTR allele mutation and have received at least 1 dose of study drug. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome. | milligrams per deciliter (mg/dl) | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Improvement in Dysglycemia Categorization at Week 48 | Baseline, Week 48 | FAS. Here, Overall Number of Participants Analyzed signifies the number participants with non-missing dysglycemia categorization at Week 48 among participants with abnormal glucose tolerance at baseline. | percentage of participants | NUMBER |
| SECONDARY | Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Day 1 up to Week 52 | Safety set included all participants who received at least 1 dose of study drug in the treatment period. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in 2-hour Blood Glucose Levels Following an OGTT to the Average of Week 36 and Week 48 | ELX/TEZ/IVA | -35.0 | 95% Confidence Interval -49.2 to -20.7 | milligrams per deciliter (mg/dl) | |
| Percentage of Participants With Improvement in Dysglycemia Categorization at Week 48 | ELX/TEZ/IVA | 37.7 | 95% Confidence Interval 24.8 to 52.1 | percentage of participants | |
| Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | ELX/TEZ/IVA | Participants with TEAEs | 67 | Participants | |
| Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | ELX/TEZ/IVA | Participants with SAEs | 6 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ELX/TEZ/IVA | 69 | |
| Overall Study | COMPLETED | ELX/TEZ/IVA | 66 | |
| Overall Study | NOT COMPLETED | ELX/TEZ/IVA | 3 |
Source ClinicalTrials.gov
Adverse events36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | ELX/TEZ/IVA | 9 | 69 | |
| other | Abdominal pain upper | Gastrointestinal disorders | ELX/TEZ/IVA | 8 | 69 | |
| other | Diarrhoea | Gastrointestinal disorders | ELX/TEZ/IVA | 13 | 69 | |
| other | Nausea | Gastrointestinal disorders | ELX/TEZ/IVA | 6 | 69 | |
| other | Vomiting | Gastrointestinal disorders | ELX/TEZ/IVA | 7 | 69 | |
| other | Fatigue | General disorders | ELX/TEZ/IVA | 5 | 69 | |
| other | Pyrexia | General disorders | ELX/TEZ/IVA | 16 | 69 | |
| other | Immunisation reaction | Immune system disorders | ELX/TEZ/IVA | 6 | 69 | |
| other | COVID-19 | Infections and infestations | ELX/TEZ/IVA | 22 | 69 | |
| other | Infective pulmonary exacerbation of cystic fibrosis | Infections and infestations | ELX/TEZ/IVA | 10 | 69 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ELX/TEZ/IVA | 0 | 69 |
| Total, other adverse events | ELX/TEZ/IVA | 62 | 69 |
| Total, serious adverse events | ELX/TEZ/IVA | 6 | 69 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40788823 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04599465
GET https://conductscience.org/api/trials/v1/NCT04599465/events?page=2