A Phase 2 interventional study of Nimacimab and Placebo in Diabetic Gastroparesis, sponsored by Bird Rock Bio, Inc.. Status unknown at 5 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-01-18.
Sponsored by Bird Rock Bio, Inc. · Phase 2, Interventional, and Treatment
This is a single blind phase 2a study to evaluate the safety, tolerability, pharmacokinetics, and exploratory efficacy of nimacimab in patients with diabetic gastroparesis.
307 studies on the registry are indexed under Gastroparesis; 68 are open to participants now.
This study's enrollment of 6 is below the median of 44 across 202 interventional studies indexed under Gastroparesis.
Browse Gastroparesis studies →Bird Rock Bio, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Diagnosed with diabetic gastroparesis, defined by:
Exclusion Criteria:
2.5 mg/kg
Drug: Nimacimab
0.9% sodium chloride
Drug: Placebo
2.5 mg/kg
0.9% sodium chloride
Frequency of clinically significant laboratory abnormalities
Time frame: Day 38
Frequency of clinically significant vital signs
Time frame: Day 38
Frequency of clinically significant ECGs
Time frame: Day 38
Nimacimab serum concentration
Area under the plasma concentration versus time curve (AUC)
Time frame: Day 3, Day 8, Day 10, Day 38
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
Time frame: Baseline, Day 10
Gastric emptying half-time as measured by gamma scans (scintigraphy) after ingestion of a radio-labeled meal.
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.
Time frame: 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).
Time frame: Baseline and 15 days
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Bird Rock Bio, Inc.