Clinical trialObsWithdrawn
Open Label Study to Analyze the Effect of Telotristat Ethyl on Weight Regulation/Gain
IIT2018-26 -Hendifar-NETCx: A Descriptive, Multicenter, Single-arm, Open Label Study to Analyze the Effect of Telotristat Ethyl on Weight Regulation/Gain
- Outcome
- Stopped earlylack of funding (Business decision)
- Phase
- Obs
- Status
- Withdrawn
- Study type
- Observational
- Start
- October 2020
- Expected end
- November 2023
- Enrollment
- 0 participants
- Sites
- 0
- Primary outcomes
- Mean change in lean body mass (measured using DXA Scan) from baseline and after 13 weeks of treatment.
- Sponsor
- Other
- Results posted
- No
- Last update
- 30 December 2020
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Brief summary public domain (ClinicalTrials.gov)
This single arm study will evaluate whether Xermelo (telotristat ethyl) associated weight gain is affects lean body mass, dietary intake, and physical and cognitive functioning among neuroendocrine tumor (NET) patients with a history of carcinoid syndrome.
Detailed description public domain (ClinicalTrials.gov)
The purpose of this study is to examine the mechanisms of weight gain associated with the drug telotristat ethyl (Xermelo) among patients with a neuroendocrine tumor (NET) with history of carcinoid syndrome. We want to know if taking Xermelo affects patients' lean body mass, quality of life, dietary intake, and physical and cognitive functioning during treatment. A better understanding of the mechanisms of weight gain from Xermelo may allow us to determine whether this drug may be beneficial for treating carcinoid syndrome, cachexia, or weight loss seen in other diseases.