Phase 2 Study of Velusetrag in Diabetic or Idiopathic Gastroparesis

Study Overview
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Brief Summary
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This is a multicenter, randomized, double-blind, incomplete block, three period fixed sequence crossover, multicenter, placebo-controlled study. The study will assess three oral doses of velusetrag (5 mg, 15 mg, and/or 30 mg) or placebo, administered once daily in three periods of 1-week duration each, with a 1-week washout period between treatment periods, in subjects with diabetic or idiopathic gastroparesis. Study 0093 will evaluate the effect of velusetrag in subjects with diabetic or idiopathic gastroparesis by assessing changes in gastric emptying.

Official Title
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A Multicenter, Double-Blind, Randomized, Placebo- Controlled, Phase 2 Study to Evaluate Velusetrag Effects on Gastric Emptying in Subjects With Diabetic or Idiopathic Gastroparesis

Conditions
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Gastroparesis

Intervention / Treatment
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* Drug: velusetrag dose 1
* Drug: velusetrag dose 2
* Drug: velusetrag dose 3
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptoms of gastroparesis (e.g., nausea, early satiety, fullness, bloating, upper abdominal pain, retching or vomiting) for at least 3 months prior to Screening Body Mass Index (BMI) between 18 and 35 kg/m2, inclusive Gastroparesis Cardinal Symptom Index (GCSI-2W) composite score ≥2 and ≤4 at Screening Delayed gastric emptying, defined as a gastric emptying half-time (GE t1/2) > 160 minutes as determined by [13C]-octanoate breath test, at Screening Upper gastrointestinal (UGI) obstruction ruled out by endoscopy or other imaging reasonably proximal to the diagnosis of gastroparesis Exclusion Criteria: Acute severe gastroenteritis within 2 weeks prior to Screening History of gastric outlet obstruction Prior history of gastric surgery, including but not limited to gastrectomy, gastric bypass, gastric banding, pyloroplasty, vagotomy, or fundoplication Recurrent vomiting, defined as vomiting more than 2 days per week Hospitalization for treatment of gastroparesis or complications of diabetes within 4 weeks prior to Screening Presence of thyroid dysfunction not controlled by treatment. Subjects with abnormal thyroid stimulating hormone (TSH), hypothyroidism, or hyperthyroidism at Screening If Type 1 or Type 2 diabetic, a glycosylated hemoglobin (HbA1c) level >10% or a glucose > 250 mg/dL at Screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>3-way crossover of velusetrag or placebo | Drug: velusetrag dose 1<br> <br> * Other names: TD-5108;Drug: velusetrag dose 2<br> <br> * Other names: TD-5108;Drug: velusetrag dose 3<br> <br> * Other names: TD-5108;Drug: placebo<br> <br> |
| Experimental: Sequence 2<br>3-way crossover of velusetrag or placebo | Drug: velusetrag dose 1<br> <br> * Other names: TD-5108;Drug: velusetrag dose 2<br> <br> * Other names: TD-5108;Drug: velusetrag dose 3<br> <br> * Other names: TD-5108;Drug: placebo<br> <br> |
| Experimental: Sequence 3<br>3-way crossover of velusetrag or placebo | Drug: velusetrag dose 1<br> <br> * Other names: TD-5108;Drug: velusetrag dose 2<br> <br> * Other names: TD-5108;Drug: velusetrag dose 3<br> <br> * Other names: TD-5108;Drug: placebo<br> <br> |
| Experimental: Sequence 4<br>3-way crossover of velusetrag or placebo | Drug: velusetrag dose 1<br> <br> * Other names: TD-5108;Drug: velusetrag dose 2<br> <br> * Other names: TD-5108;Drug: velusetrag dose 3<br> <br> * Other names: TD-5108;Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric emptying half time (GE t1/2) |  | From baseline to week 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of lag time to gastric emptying (tlag) |  | From baseline to Week 5 | 
| Vital signs | Assess the safety and tolerability in subjects with diabetic or idiopathic gastroparesis | From baseline to Day 49 | 
| ECGs |  | From baseline to Day 49 | 
| Number of adverse events |  | From baseline to Day 49 | 

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