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

• Status: Unknown status
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bird Rock Bio, Inc.

Criteria

Inclusion Criteria:

• Diagnosed with type 1 or type 2 diabetes

• Diagnosed with diabetic gastroparesis, defined by:

1. 3 month past or current history of symptoms of gastroparesis (e.g. nausea, vomiting, bloating, abdominal pain, or feeling full earlier than normal after eating)

2. Screening or historical scintigraphy (3 years prior to screening) with > 20% of solid contents retained at 4 hours.

• BMI >= 20.0 and < = 50.0 kg/m2

Exclusion Criteria:

• Participants on prokinetic therapy should have these medications withdrawn at least 7 days prior to any study scintigraphy exam and at least 7 days prior to the first dose through Day 15 of treatment.

• Participants with any active prokinetic device are excluded, unless device is turned off for at least 7 days prior to any study scintigraphy exam and at least 7 days prior to the first dose through Day 15 of treatment.

• Participants who are currently participating in or have participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.

• Participants with uncontrolled diabetes. Participants with controlled diabetes are allowed (insulin is allowed). HbA1c>9.9% at screening are excluded.