NCT01456052

A Study to Evaluate Safety and Efficacy of Telotristat Etiprate (LX1606) in Participants With Acute, Mild to Moderate Ulcerative Colitis

Completed Phase 2 Results posted Last updated 23 May 2019

What this trial tests

Phase 2 trial testing Telotristat Etiprate in Ulcerative Colitis in 59 participants. Completed in 3 September 2013.

Timeline

30 January 2012

Primary endpoint
3 September 2013

3 September 2013

Quick facts

Lead sponsor	Lexicon Pharmaceuticals
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	59
Start date	30 January 2012
Primary completion	3 September 2013
Estimated completion	3 September 2013
Sites	24 locations across Slovakia, Poland, United States, Lithuania

Drugs / interventions tested

• Telotristat Etiprate — full drug profile →
• Placebo

Conditions studied

• Ulcerative Colitis — all drugs for Ulcerative Colitis →

Sponsor

Lexicon Pharmaceuticals — full company profile →

Who can join

Adults 18 to 70, any sex, with Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Experiencing a Treatment Emergent Adverse Event Primary · 8 weeks

Group	Value	95% CI
Placebo	3
Low Dose LX1606	9
High Dose Telotristat Etiprate	10

Number of Participants Achieving Clinical Response Secondary · 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-

Group	Value	95% CI
Placebo	4
Low Dose Telotristat Etiprate	8
High Dose Telotristat Etiprate	8

Number of Participants Achieving Clinical Remission Secondary · 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 indicatin

Group	Value	95% CI
Placebo	2
Low Dose Telotristat Etiprate	2
High Dose Telotristat Etiprate	3

Change From Baseline in Total Modified Mayo Score Secondary · 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.

Group	Value	95% CI
Placebo	-2.38	± 2.973
Low Dose Telotristat Etiprate	-1.89	± 2.865
High Dose Telotristat Etiprate	-2.53	± 2.389

Adverse events — posted to ClinicalTrials.gov

Time frame: 10 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 1/10 (10%)

Deaths: —

Low Dose Telotristat Etiprate

Serious: 3/24 (13%)

Deaths: —

High Dose Telotristat Etiprate

Serious: 2/24 (8%)

Deaths: —

Serious adverse events (3 terms)

Reaction	System	Placebo	Low Dose Telotristat Etipr…	High Dose Telotristat Etip…
Colitis ulcerative	Gastrointestinal disorders	—	—	—
Appendicitis	Infections and infestations	—	—	—
Iron deficiency anemia	Blood and lymphatic system disorders	—	—	—

Other adverse events (9 terms — click to expand)

Reaction	System	Placebo	Low Dose Telotristat Etipr…	High Dose Telotristat Etip…
Colitis ulcerative	Gastrointestinal disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—
Sinusitis	Infections and infestations	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—
Influenza	Infections and infestations	—	—	—
Dizziness	Nervous system disorders	—	—	—
Memory impairment	Nervous system disorders	—	—	—

Most-reported serious reactions: Colitis ulcerative, Appendicitis, Iron deficiency anemia.

Data from ClinicalTrials.gov NCT01456052 adverse events section.

Sponsor's own description

This is a multicenter, placebo-controlled, parallel-group, pilot study to evaluate safety and preliminary effectiveness of two blinded dose levels of telotristat etiprate (LX1606) in participants with acute, mild to moderate ulcerative colitis on 5-aminosalicylic acid/mesalamine therapy.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.