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

Phase 2

• Conditions: Diabetic Gastroparesis
• Interventions: Drug: Nimacimab; Drug: Placebo

• Registration Number: NCT03900325
• Lead Sponsor: Bird Rock Bio, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-27
• Study First Submitted QC: 2019-04-01
• Study First Posted: 2019-04-03
• Status Verified: 2019-08
• Study Start: 2019-08-01
• Primary Completion: 2020-01
• Last Update Submitted: 2020-01-14
• Last Update Posted: 2020-01-18
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6

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• Participants on prokinetic therapy should have these medications withdrawn at least 7 days prior to any study scintigraphy exam and at least 7 days prior to the first dose through Day 15 of treatment.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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Nimacimab	Nimacimab	2.5 mg/kg
Placebo	Placebo	0.9% sodium chloride

Primary Outcome Measures

Name	Time	Method
Frequency of clinically significant laboratory abnormalities	Day 38
Frequency of clinically significant vital signs	Day 38
Frequency of clinically significant ECGs	Day 38

Secondary Outcome Measures

Name	Time	Method
Nimacimab serum concentration	Day 3, Day 8, Day 10, Day 38	Area under the plasma concentration versus time curve (AUC)

Trial Locations

Locations (5)

Panax Clinical Research; 🇺🇸 Miami, Florida, United States

International Research Associates, LLC; 🇺🇸 Miami, Florida, United States

PRN of Kansas; 🇺🇸 Wichita, Kansas, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

ClinSearch; 🇺🇸 Chattanooga, Tennessee, United States