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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
Awards & highlights
Study Summary
This is a single blind phase 2a study to evaluate the safety, tolerability, pharmacokinetics, and exploratory efficacy of nimacimab in patients with diabetic gastroparesis.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency of clinically significant ECGs
Frequency of clinically significant laboratory abnormalities
Frequency of clinically significant vital signs
Secondary outcome measures
Nimacimab serum concentration
Other outcome measures
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.
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
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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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