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Trial · NCT04034745

Open Label Study to Analyze the Effect of Telotristat Ethyl on Weight Regulation/Gain

NCT04034745, Withdrawn, Andrew Hendifar, MD

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Open Label Study to Analyze the Effect of Telotristat Ethyl on Weight Regulation/Gain. Trials, record NCT04034745. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04034745

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Open Label Study to Analyze the Effect of Telotristat Ethyl on Weight Regulation/Gain
NCT number
NCT04034745
Status
Withdrawn
Enrollment
0 participants, actual
Lead sponsor
Andrew Hendifar, MD
Conditions
Pancreatic Cancer, Neuroendocrine Tumors, Cachexia; Cancer
Interventions
telotristat ethyl
First posted
2019-07-26
Last updated
2020-12-30

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryMean change in lean body mass (measured using DXA Scan) from baseline and after 13 weeks of treatment.From baseline to 13 weeks after treatment
SecondaryMean change in patient reported outcomes using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) from baseline up to 3 years post treatment.From baseline to 3 years post treatmentThe summary score (SS) is a mean of 13 QLQ-C30 subscale scores, ranging from 0 to 100, with a higher SS rating reflecting a better health status.
SecondaryMean change in patient reported outcomes using the Montreal Cognitive Assessment (MOCA) test from baseline up to 3 years post treatment.From baseline to 3 years post treatmentMOCA scores range between 0 and 30, with higher scores indicating higher cognitive function.
SecondaryMean change in patient reported outcomes using a stool survey measured from baseline and after 13 weeks of treatment.From baseline to 13 weeks post-treatment.
The stool survey is a non-validated descriptive measure of gastrointestinal symptoms by taking the mean score on a scale of 0 - 10, where 0 indicates no symptoms and higher scores denote a worsening of symptoms.
SecondaryMean change in calories consumed using a 24-hour food diary from baseline and after 13 weeks of treatment.From baseline to 13 weeks post-treatment
SecondaryMean change in daily activity levels (steps) as measured using a wrist-worn fitness tracker (e.g., Fitbit) from baseline and for the duration of the 13 weeks of treatment.From baseline to 13 weeks post-treatment
SecondaryMean change in daily activity levels [stairs (floors) climbed] as measured using a wrist-worn fitness tracker (e.g., Fitbit) from baseline and for the duration of the 13 weeks of treatment.From baseline to 13 weeks post-treatment
SecondaryMean change in daily activity levels (sleep duration) as measured using a wrist-worn fitness tracker (e.g., Fitbit) from baseline and for the duration of the 13 weeks of treatment.From baseline to 13 weeks post-treatment
SecondaryMean change in daily activity levels (heart rate) as measured using a wrist-worn fitness tracker (e.g., Fitbit) from baseline and for the duration of the 13 weeks of treatment.From baseline to 13 weeks post-treatment
SecondaryMean change in daily activity levels (active minutes) as measured using a wrist-worn fitness tracker (e.g., Fitbit) from baseline and for the duration of the 13 weeks of treatment.From baseline to 13 weeks post-treatment

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT04034745

GET https://conductscience.org/api/trials/v1/NCT04034745/registered