CLINICAL TRIALS PROFILE FOR TELOTRISTAT ETIPRATE

All Clinical Trials for TELOTRISTAT ETIPRATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00853047 ↗	Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome Not Managed by Stable-Dose Octreotide Therapy	Completed	Lexicon Pharmaceuticals	Phase 2	2009-03-01	The purpose of this study is to evaluate the safety and tolerability of telotristat etiprate (LX1606) versus a placebo control in participants with symptomatic carcinoid syndrome not managed by stable-dose long-acting octreotide therapy. Following determination of the maximally tolerated or effective dose, cohort expansion will occur to confirm effect on symptoms and safety profile.
NCT01104415 ↗	Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome	Completed	Lexicon Pharmaceuticals	Phase 2	2010-06-15	The purpose of the study is to evaluate the safety and tolerability of orally administered telotristat etiprate (LX1606) in participants with symptomatic carcinoid syndrome.
NCT01456052 ↗	A Study to Evaluate Safety and Efficacy of Telotristat Etiprate (LX1606) in Participants With Acute, Mild to Moderate Ulcerative Colitis	Completed	Lexicon Pharmaceuticals	Phase 2	2012-01-30	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.
NCT01677910 ↗	TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)	Completed	Lexicon Pharmaceuticals	Phase 3	2013-01-08	The primary objective of the study is to confirm that at least 1 or more doses of telotristat etiprate compared to placebo is effective in reducing the number of daily bowel movements (BMs) from baseline averaged over the 12-week double-blind portion (Treatment Period) of the trial in patients not adequately controlled by current SSA therapy.
NCT01932528 ↗	An Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate in Males	Completed	Lexicon Pharmaceuticals	Phase 1	2013-08-01	To evaluate the metabolism and routes and extent of elimination of telotristat etiprate and its primary metabolite LX1033.
NCT02026063 ↗	Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms	Completed	Lexicon Pharmaceuticals	Phase 3	2014-01-14	The primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate.
NCT02063659 ↗	Telotristat Etiprate for Carcinoid Syndrome Therapy	Completed	Lexicon Pharmaceuticals	Phase 3	2014-03-11	The purpose of the study is to evaluate the effect of telotristat etiprate versus placebo on the incidence of treatment-emergent adverse events and on 5-hydroxyindoleacetic acid (5-HIAA) levels.

Clinical Trial Conditions for TELOTRISTAT ETIPRATE

Condition Name

Condition Name for TELOTRISTAT ETIPRATE
Intervention	Trials
Carcinoid Syndrome	7
Drug Interactions	3
QT Interval	1
Renal Impairment	1

Condition MeSH

Condition MeSH for TELOTRISTAT ETIPRATE
Intervention	Trials
Malignant Carcinoid Syndrome	7
Serotonin Syndrome	7
Carcinoid Tumor	5
Syndrome	5

Clinical Trial Locations for TELOTRISTAT ETIPRATE

Trials by Country

Trials by Country for TELOTRISTAT ETIPRATE
Location	Trials
United States	46
Australia	11
Canada	6
United Kingdom	5
Germany	5

Trials by US State

Trials by US State for TELOTRISTAT ETIPRATE
Location	Trials
California	5
New York	4
Texas	4
Massachusetts	4
Iowa	4

Clinical Trial Progress for TELOTRISTAT ETIPRATE

Clinical Trial Phase

Clinical Trial Phase for TELOTRISTAT ETIPRATE
Clinical Trial Phase	Trials
Phase 3	3
Phase 2	4
Phase 1	8

Clinical Trial Status

Clinical Trial Status for TELOTRISTAT ETIPRATE
Clinical Trial Phase	Trials
Completed	14
Recruiting	1

Clinical Trial Sponsors for TELOTRISTAT ETIPRATE

Sponsor Name

Sponsor Name for TELOTRISTAT ETIPRATE
Sponsor	Trials
Lexicon Pharmaceuticals	12
Ipsen	2
National Cancer Institute (NCI)	1

Sponsor Type

Sponsor Type for TELOTRISTAT ETIPRATE
Sponsor	Trials
Industry	14
NIH	1
Other	1