Trial · NCT01456052
A Study to Evaluate Safety and Efficacy of Telotristat Etiprate (LX1606) in Participants With Acute, Mild to Moderate Ulcerative Colitis
NCT01456052, Phase 2, Completed, Lexicon Pharmaceuticals; results first posted 2015-03-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate Safety and Efficacy of Telotristat Etiprate (LX1606) in Participants With Acute, Mild to Moderate Ulcerative Colitis. Trials, record NCT01456052. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01456052
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Safety and Efficacy of Telotristat Etiprate (LX1606) in Participants With Acute, Mild to Moderate Ulcerative Colitis
- NCT number
- NCT01456052
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 59 participants, actual
- Lead sponsor
- Lexicon Pharmaceuticals
- Conditions
- Ulcerative Colitis
- Interventions
- Telotristat Etiprate, Placebo
- First posted
- 2011-10-20
- Last updated
- 2019-05-23
- Results first posted
- 2015-03-11
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Experiencing a Treatment Emergent Adverse Event | 8 weeks | |
| Secondary | Number of Participants Achieving Clinical Response | Baseline to 8 weeks | Clinical response is defined as a decrease in the total modified Mayo score from baseline of ≥3 or a ≥30% decrease in the total modified Mayo score from baseline, along with a decrease in the rectal bleeding score ≥1 or an absolute rectal bleeding score ≤1 at Week 8. A modified Mayo score was used to evaluate disease activity using 4 components, including stool frequency, rectal bleeding, endoscopy, and physician assessment. Components = Stool frequency score 0-3 (normal- \>4 stools/day more than normal), rectal bleeding score 0-3 (none-passing blood alone), mucosal appearance at endoscopy 0-3 (normal-severe disease), physician rating of disease activity 0-3 (normal-severe). The total Modified Mayo score ranges from 0 to 12, with higher scores indicating greater disease severity. |
| Secondary | Number of Participants Achieving Clinical Remission | Baseline to 8 weeks | Clinical remission is defined as a total modified Mayo score ≤2 with no individual score \>1 at Week 8. A modified Mayo score was used to evaluate disease activity using 4 components, including stool frequency, rectal bleeding, endoscopy, and physician assessment. Components = Stool frequency score 0-3 (normal- \>4 stools/day more than normal), rectal bleeding score 0-3 (none-passing blood alone), mucosal appearance at endoscopy 0-3 (normal-severe disease), physician rating of disease activity 0-3 (normal-severe). The total Modified Mayo score ranges from 0 to 12, with higher scores indicating greater disease severity. |
| Secondary | Change From Baseline in Total Modified Mayo Score | Baseline to 8 weeks | A modified Mayo score was used to evaluate disease activity using 4 components, including stool frequency, rectal bleeding, endoscopy, and physician assessment. Components = Stool frequency score 0-3 (normal- \>4 stools/day more than normal), rectal bleeding score 0-3 (none-passing blood alone), mucosal appearance at endoscopy 0-3 (normal-severe disease), physician rating of disease activity 0-3 (normal-severe). The total Modified Mayo score ranges from 0 to 12, with higher scores indicating greater disease severity. |
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 | Number of Participants Experiencing a Treatment Emergent Adverse Event | 8 weeks | Safety population included all treated participants who had taken any fraction of a study drug dose. | participants | NUMBER |
| SECONDARY | Number of Participants Achieving Clinical Response | Baseline to 8 weeks | Intent-to-treat (ITT) Population included all randomly assigned participants. | participants | NUMBER |
| SECONDARY | Number of Participants Achieving Clinical Remission | Baseline to 8 weeks | ITT Population included all randomly assigned participants. | participants | NUMBER |
| SECONDARY | Change From Baseline in Total Modified Mayo Score | Baseline to 8 weeks | Participants from the ITT Population, all randomly assigned participants, with data available for analysis. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Experiencing a Treatment Emergent Adverse Event | Placebo | 3 | participants | ||
| Number of Participants Experiencing a Treatment Emergent Adverse Event | Low Dose LX1606 | 9 | participants | ||
| Number of Participants Experiencing a Treatment Emergent Adverse Event | High Dose Telotristat Etiprate | 10 | participants | ||
| Number of Participants Achieving Clinical Response | Placebo | 4 | participants | ||
| Number of Participants Achieving Clinical Response | Low Dose Telotristat Etiprate | 8 | participants | ||
| Number of Participants Achieving Clinical Response | High Dose Telotristat Etiprate | 8 | participants | ||
| Number of Participants Achieving Clinical Remission | Placebo | 2 | participants | ||
| Number of Participants Achieving Clinical Remission | Low Dose Telotristat Etiprate | 2 | participants | ||
| Number of Participants Achieving Clinical Remission | High Dose Telotristat Etiprate | 3 | participants | ||
| Change From Baseline in Total Modified Mayo Score | Placebo | -2.38 | Standard Deviation 2.973 | units on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 10 | |
| Overall Study | STARTED | Low Dose Telotristat Etiprate | 25 | |
| Overall Study | STARTED | High Dose Telotristat Etiprate | 24 | |
| Overall Study | COMPLETED | Placebo | 8 | |
| Overall Study | COMPLETED | Low Dose Telotristat Etiprate | 20 | |
| Overall Study | COMPLETED | High Dose Telotristat Etiprate | 19 | |
| Overall Study | NOT COMPLETED | Placebo | 2 | |
| Overall Study | NOT COMPLETED | Low Dose Telotristat Etiprate | 5 | |
| Overall Study | NOT COMPLETED | High Dose Telotristat Etiprate | 5 |
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 | Colitis ulcerative | Gastrointestinal disorders | Placebo | 1 | 10 | 1 |
| other | Colitis ulcerative | Gastrointestinal disorders | Low Dose Telotristat Etiprate | 2 | 24 | 2 |
| other | Colitis ulcerative | Gastrointestinal disorders | High Dose Telotristat Etiprate | 1 | 24 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 0 | 10 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Low Dose Telotristat Etiprate | 2 | 24 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | High Dose Telotristat Etiprate | 0 | 24 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 0 | 10 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Low Dose Telotristat Etiprate | 2 | 24 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | High Dose Telotristat Etiprate | 0 | 24 | 0 |
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 0 | 10 | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Low Dose Telotristat Etiprate | ||
| Total, all-cause mortality | High Dose Telotristat Etiprate | ||
| Total, other adverse events | Placebo | 3 | 10 |
| Total, other adverse events | Low Dose Telotristat Etiprate | 9 | 24 |
| Total, other adverse events | High Dose Telotristat Etiprate | 2 | 24 |
| Total, serious adverse events | Placebo | 1 | 10 |
| Total, serious adverse events | Low Dose Telotristat Etiprate | 3 | 24 |
| Total, serious adverse events | High Dose Telotristat Etiprate | 2 | 24 |
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 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/NCT01456052
GET https://conductscience.org/api/trials/v1/NCT01456052/events?page=2