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Monoclonal Antibodies
Nimacimab for Gastroparesis
Phase 2
Waitlist Available
Research Sponsored by Bird Rock Bio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 3, day 8, day 10, day 38
Summary
This trial is testing a new medication called nimacimab to see if it can help people with diabetes who have stomach problems. The study focuses on patients whose stomachs take too long to empty, a condition known as diabetic gastroparesis. Researchers want to find out if nimacimab can improve their symptoms and how the body handles the medication.
Eligible Conditions
- Gastroparesis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 3, day 8, day 10, day 38
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 3, day 8, day 10, day 38
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Nimacimab serum concentration
Other study objectives
Change from baseline in American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) Composite Score at 15 days
Gastric emptying half-time as measured by gamma scans (scintigraphy) after ingestion of a radio-labeled meal.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: NimacimabExperimental Treatment1 Intervention
2.5 mg/kg
Group II: PlaceboPlacebo Group1 Intervention
0.9% sodium chloride
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Who is running the clinical trial?
Bird Rock Bio, Inc.Lead Sponsor
2 Previous Clinical Trials
84 Total Patients Enrolled
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