The Diabetic and Idiopathic Gastroparesis Efficacy, Safety, and Tolerability (DIGEST) Study

Study Overview
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Brief Summary
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Study 0099 explores the efficacy and safety of multiple doses of velusetrag in the treatment of symptoms in subjects with diabetic or idiopathic gastroparesis. Three dose levels of velusetrag will be evaluated and compared to placebo for approximately 12 weeks of therapy. In addition, the study will be used to evaluate the psychometric properties of the Gastroparesis Rating Scale (GRS), a daily patient-reported outcome (PRO) measure.

Official Title
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A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy, Safety, and Tolerability of Velusetrag for the Treatment of Diabetic or Idiopathic Gastroparesis

Conditions
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Gastroparesis

Intervention / Treatment
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* Drug: Velusetrag
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptoms of gastroparesis (eg, nausea, early satiety, fullness, bloating, upper abdominal pain, retching or vomiting) for at least 3 months prior to Screening Composite score ≥2and <5 on nausea, bloating, feeling excessively full after meals, and not able to finish a normal-sized meal items (on the GCSI-2W) at Screening Delayed gastric emptying by either GES (gastric emptying scintigraphy) or GEBT(gastric emptying breath test) Upper gastrointestinal obstruction ruled out by endoscopy or other imaging (eg, computed tomography) after the onset of gastroparesis symptoms Willing to abstain from prohibited medications, including but not limited to, anticholinergics, acetylcholinesterase antagonists, or promotility medications (eg, metoclopramide, domperidone, prucalopride, erythromycin) for: 24 hours prior to gastric emptying test during Screening, if applicable; 24 hours prior to start of the Baseline period; and during the Baseline Period GCSI-24H 7-day mean composite score ≥2.5 and <5 at Day 1 Exclusion Criteria: If Type 1 or Type 2 diabetic, a glycosylated hemoglobin (HbA1c) level >11% Prior history of gastric surgery, including but not limited to gastrectomy, gastric bypass, gastric banding, pyloroplasty, vagotomy, or fundoplication, which has manipulated the natural anatomy of the stomach History of intrapyloric botulinum toxin injection within 3 months of Screening or currently has functioning implantable electric stimulator History of alcohol or drug abuse or dependence within the last year prior to Screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Velusetrag 5mg<br>Velusetrag 5mg capsules QD (once daily) x 12 weeks | Drug: Velusetrag<br> <br> * Other names: TD-5108;|
| Experimental: Velusetrag 15mg<br>Velusetrag 15mg capsules QD x 12 weeks | Drug: Velusetrag<br> <br> * Other names: TD-5108;|
| Experimental: Velusetrag 30mg<br>Velusetrag 30mg capsules QD x 12 weeks | Drug: Velusetrag<br> <br> * Other names: TD-5108;|
| Placebo Comparator: Placebo<br>Placebo capsules QD x 12 weeks | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day mean GCSI-24H (Gastroparesis Cardinal Symptoms Index) composite score |  | At Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric emptying half-time |  | At Week 4 | 
| Adverse events |  | 103 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroparesis, Diabetic, Idiopathic