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

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Diabetic Gastroparesis

In brief

This is a single blind phase 2a study to evaluate the safety, tolerability, pharmacokinetics, and exploratory efficacy of nimacimab in patients with diabetic gastroparesis.

Key facts

Study ID

NCT03900325

Run by

Bird Rock Bio, Inc.

People needed

6

Starts

2019-08-01

Expected to finish

2020-04-01

Last updated by the study team

2020-01-18

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with type 1 or type 2 diabetes
• Diagnosed with diabetic gastroparesis, defined by:
• 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)
• 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

You may not qualify if…

• Participants on prokinetic therapy should have these medications withdrawn at least 7 days prior to any study scintigraphy exam and at least 7 days prior to the first dose through Day 15 of treatment.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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.