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This is a single blind phase 2a study to evaluate the safety, tolerability, pharmacokinetics, and exploratory efficacy of nimacimab in patients with diabetic gastroparesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nimacimab | Experimental | 2.5 mg/kg |
|
| Placebo | Placebo Comparator | 0.9% sodium chloride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nimacimab | Drug | 2.5 mg/kg |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of clinically significant laboratory abnormalities | Day 38 | |
| Frequency of clinically significant vital signs | Day 38 | |
| Frequency of clinically significant ECGs | Day 38 |
| Measure | Description | Time Frame |
|---|---|---|
| Nimacimab serum concentration | Area under the plasma concentration versus time curve (AUC) | Day 3, Day 8, Day 10, Day 38 |
| Measure | Description | Time Frame |
|---|---|---|
| Measure rate of gastric emptying after ingestion of a radio-labeled meal as measured by gamma scans (scintigraphy) at 0, 0.5, 1, 2, 3, and 4 hours post meal | Baseline, Day 10 | |
| Gastric emptying half-time as measured by gamma scans (scintigraphy) after ingestion of a radio-labeled meal. |
Inclusion Criteria:
Diagnosed with type 1 or type 2 diabetes
Diagnosed with diabetic gastroparesis, defined by:
BMI >= 20.0 and < = 50.0 kg/m2
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Panax Clinical Research | Miami | Florida | 33014 | United States | ||
| International Research Associates, LLC |
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| Drug |
0.9% sodium chloride |
|
Half time (t1/2) of gastric emptying (GE) of solids is the time for half of the ingested solids or liquids to leave the stomach.
| Baseline, Day 10 |
| Change from baseline in American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) Composite Score at 15 days | The ANMS GCSI-DD composite score includes score of nausea, early satiety, upper abdominal pain and postprandial fullness. The severity scores of these symptoms range from 0 ( none) to 4 (very severe). | Baseline and 15 days |
| Miami |
| Florida |
| 33183 |
| United States |
| PRN of Kansas | Wichita | Kansas | 67205 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| ClinSearch | Chattanooga | Tennessee | 37421 | United States |