Trial · NCT02597712
YF476 in Barrett's Esophagus
NCT02597712, Phase 2, Completed, Trio Medicines Ltd.; results first posted 2021-04-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. YF476 in Barrett's Esophagus. Trials, record NCT02597712. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02597712
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- YF476 in Barrett's Esophagus
- NCT number
- NCT02597712
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 27 participants, actual
- Lead sponsor
- Trio Medicines Ltd.
- Conditions
- Barrett's Esophagus
- Interventions
- YF476, YF476 placebo
- First posted
- 2015-11-05
- Last updated
- 2021-04-12
- Results first posted
- 2021-04-12
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Ki67 Biomarker Expression | Baseline and Week 12 | Esophagogastroduodenoscopy (EGD) was performed to enable taking biopsies for assessment of Ki67 expression, a marker of cellular proliferation. Ki67 expression was assessed by immunohistochemistry and calculating the number of Ki67 positive cells per mm\^2 of Barrett's epithelium. |
| Secondary | Expression of Biomarkers Potentially Associated With Esophageal Adenocarcinoma (EAC) | Week 12 | Blood samples were taken for assay of biomarkers associated with esophageal adenocarcinoma. Changes in biomarker expression were derived from RNA-Sequencing and calculated as log-fold change comparing the treatment group to the placebo group. The nature of how results are derived by RNA-sequencing means summary statistics cannot be generated individually for each arm and a value has not been calculated for each individual participant. Therefore, results are reported as the relative change in biomarker expression in the treatment arm compared to the placebo arm. |
| Secondary | Abundance of Biomarkers of Gastric Acid Suppression | Week 4, Week 6, Week 8, Week 12 and Follow-up (4 weeks after stopping YF476 treatment) | Blood samples were taken to assess the effects of YF476 on fasting serum gastrin, a marker of gastric acid suppression |
| Secondary | Abundance of Biomarkers of ECL Cell Hyperplasia | Week 4, Week 6, Week 8, Week 12 and Follow-up (4 weeks after stopping YF476 treatment) | Blood samples were taken to assess the effects of YF476 on fasting plasma CgA, a marker of ECL cell hyperplasia |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Ki67 Biomarker Expression | Baseline and Week 12 | 3 patients in the treatment arm and 1 patient in the placebo arm were withdrawn from the study due to reasons unrelated to the treatment. Therefore, Week 12 data show results from 10 patients per arm. | cells/mm^2 | MEAN |
| SECONDARY | Expression of Biomarkers Potentially Associated With Esophageal Adenocarcinoma (EAC) | Week 12 | 3 patients in the treatment arm were withdrawn from the study due to reasons unrelated to the treatment. Therefore, results are reported for 10 patients. | relative log-fold change | NUMBER |
| SECONDARY | Abundance of Biomarkers of Gastric Acid Suppression | Week 4, Week 6, Week 8, Week 12 and Follow-up (4 weeks after stopping YF476 treatment) | After 6 patients (3 per treatment) had their Week 4 and 8 visits, the protocol was amended so that those visits were replaced by a single visit at Week 6 in order to reduce the total number of visits. | pmol/L | MEAN |
| SECONDARY | Abundance of Biomarkers of ECL Cell Hyperplasia | Week 4, Week 6, Week 8, Week 12 and Follow-up (4 weeks after stopping YF476 treatment) | After 6 patients (3 per treatment) had their Week 4 and 8 visits, the protocol was amended so that those visits were replaced by a single visit at Week 6 in order to reduce the total number of visits. | nmol/L | MEAN |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Ki67 Biomarker Expression | Treatment | Baseline | 1539 | Standard Deviation 514 | cells/mm^2 |
| Change in Ki67 Biomarker Expression | YF476 Placebo | Baseline | 1556 | Standard Deviation 622 | cells/mm^2 |
| Change in Ki67 Biomarker Expression | Treatment | Week 12 | 1575 | Standard Deviation 620.7 | cells/mm^2 |
| Change in Ki67 Biomarker Expression | YF476 Placebo | Week 12 | 1864 | Standard Deviation 640.3 | cells/mm^2 |
| Expression of Biomarkers Potentially Associated With Esophageal Adenocarcinoma (EAC) | Treatment | CCK2R, Week 12 | -1.19 | relative log-fold change | |
| Expression of Biomarkers Potentially Associated With Esophageal Adenocarcinoma (EAC) | Treatment | PTGS2, Week 12 | 0.31 | relative log-fold change | |
| Expression of Biomarkers Potentially Associated With Esophageal Adenocarcinoma (EAC) | Treatment | DCLK1, Week 12 | -0.34 | relative log-fold change | |
| Abundance of Biomarkers of Gastric Acid Suppression | Treatment | Week 4 | 242.6 | Standard Deviation 142.3 | pmol/L |
| Abundance of Biomarkers of Gastric Acid Suppression | YF476 Placebo | Week 4 | 43.6 | Standard Deviation 9.9 | pmol/L |
| Abundance of Biomarkers of Gastric Acid Suppression | Treatment | Week 6 | 103.3 | Standard Deviation 89.9 | pmol/L |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment | 13 | |
| Overall Study | STARTED | YF476 Placebo | 11 | |
| Overall Study | COMPLETED | Treatment | 10 | |
| Overall Study | COMPLETED | YF476 Placebo | 10 | |
| Overall Study | NOT COMPLETED | Treatment | 3 | |
| Overall Study | NOT COMPLETED | YF476 Placebo | 1 |
Source ClinicalTrials.gov
Adverse events60
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 | Constipation | Gastrointestinal disorders | Treatment | 2 | 13 | 2 |
| other | Constipation | Gastrointestinal disorders | YF476 Placebo | 1 | 11 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Treatment | 2 | 13 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | YF476 Placebo | 1 | 11 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Treatment | 1 | 13 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | YF476 Placebo | 1 | 11 | 1 |
| other | Nausea | Gastrointestinal disorders | Treatment | 1 | 13 | 1 |
| other | Nausea | Gastrointestinal disorders | YF476 Placebo | 1 | 11 | 1 |
| other | Rectal haemorrhage | Gastrointestinal disorders | Treatment | 1 | 13 | 1 |
| other | Rectal haemorrhage | Gastrointestinal disorders | YF476 Placebo | 1 | 11 | 1 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment | 0 | 13 |
| Total, all-cause mortality | YF476 Placebo | 0 | 11 |
| Total, other adverse events | Treatment | 13 | 13 |
| Total, other adverse events | YF476 Placebo | 11 | 11 |
| Total, serious adverse events | Treatment | 1 | 13 |
| Total, serious adverse events | YF476 Placebo | 0 | 11 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment vs YF476 Placebo: deaths from any cause | Trial comparisons |
| Treatment vs YF476 Placebo: serious adverse events | Trial comparisons |
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/NCT02597712
GET https://conductscience.org/api/trials/v1/NCT02597712/results?page=2