CLINICAL TRIALS PROFILE FOR TELOTRISTAT ETHYL

Clinical Trials for Telotristat ethyl

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT03302845 ↗	A Phase 1 Study to Evaluate the Effects of Omeprazole and Famotidine on the Absorption of Telotristat Ethyl in Healthy Subjects	Completed	Lexicon Pharmaceuticals	Phase 1	This drug-drug interaction study will evaluate the impact of two different acid reducing agents (from two different drug classes) co-administered with a single dose of telotristat ethyl.
NCT03423446 ↗	Study to Evaluate the Pharmacokinetics of Telotristat Ethyl in Subjects With Severe Hepatic Impairment	Completed	Lexicon Pharmaceuticals	Phase 1	This study is designed to evaluate the effect of severe hepatic impairment on the pharmacokinetics (PK) of telotristat ethyl (TE) ( LP-778902 active moiety, metabolite), following administration of a single dose of TE 250 mg (1 x 250-mg tablet) compared to healthy, demographically-matched subjects with normal hepatic function.
NCT03790111 ↗	A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer	Active, not recruiting	Lexicon Pharmaceuticals	Phase 2	A Phase 2, multicenter, open-label, 2-stage study to assess the safety, tolerability, and efficacy of XERMELO in combination with first-line (1L) therapy (cisplatin [cis] plus gemcitabine [gem])
NCT03790111 ↗	A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer	Active, not recruiting	TerSera Therapeutics LLC	Phase 2	A Phase 2, multicenter, open-label, 2-stage study to assess the safety, tolerability, and efficacy of XERMELO in combination with first-line (1L) therapy (cisplatin [cis] plus gemcitabine [gem])
NCT03910387 ↗	Telotristat Ethyl to Promote Weight Stability in Patients With Advanced Stage Pancreatic Cancer	Recruiting	Lexicon Pharmaceuticals	Phase 2	This phase II trial studies how well telotristat ethyl works in promoting weight stability in patients with pancreatic adenocarcinoma that has come back and spread to other places in the body. Telotristat ethyl may decrease bowel movements which may make patients gain weight. Stabilizing weight may help patients tolerate chemotherapy better and improve longevity.
NCT03910387 ↗	Telotristat Ethyl to Promote Weight Stability in Patients With Advanced Stage Pancreatic Cancer	Recruiting	TerSera Therapeutics LLC	Phase 2	This phase II trial studies how well telotristat ethyl works in promoting weight stability in patients with pancreatic adenocarcinoma that has come back and spread to other places in the body. Telotristat ethyl may decrease bowel movements which may make patients gain weight. Stabilizing weight may help patients tolerate chemotherapy better and improve longevity.

Clinical Trial Conditions for Telotristat ethyl

Condition Name

Condition Name for
Intervention	Trials
Carcinoid Syndrome	2
Neuroendocrine Tumors	2
Biliary Tract Cancer	1
Recurrent Pancreatic Adenocarcinoma	1

Condition MeSH

Condition MeSH for
Intervention	Trials
Neuroendocrine Tumors	5
Carcinoid Tumor	4
Malignant Carcinoid Syndrome	3
Serotonin Syndrome	3

Clinical Trial Locations for Telotristat ethyl

Trials by Country

Trials by Country for
Location	Trials
United States	19

Trials by US State

Trials by US State for
Location	Trials
Texas	5
Florida	2
California	1
Arizona	1
Iowa	1

Clinical Trial Progress for Telotristat ethyl

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 3	2
Phase 2	5
Phase 1	2

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Recruiting	3
Withdrawn	2
Completed	2

Clinical Trial Sponsors for Telotristat ethyl

Sponsor Name

Sponsor Name for
Sponsor	Trials
Lexicon Pharmaceuticals	4
TerSera Therapeutics LLC	3
M.D. Anderson Cancer Center	2

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	8
Other	7