Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy of Nimacimab in Patients With Diabetic 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 3, day 8, day 10, day 38 for reporting.

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.