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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 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

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

Find a Location

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.
~1 spots leftby Apr 2025