Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy of Nimacimab in Patients With Diabetic Gastroparesis
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Nimacimab 2.5 mg/kg |
Drug: Nimacimab
2.5 mg/kg
|
Placebo Comparator: Placebo 0.9% sodium chloride |
Drug: Placebo
0.9% sodium chloride
|
Outcome Measures
Primary Outcome Measures
- 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
- Nimacimab serum concentration [Day 3, Day 8, Day 10, Day 38]
Area under the plasma concentration versus time curve (AUC)
Other Outcome Measures
- 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 [Baseline, Day 10]
- Gastric emptying half-time as measured by gamma scans (scintigraphy) after ingestion of a radio-labeled meal. [Baseline, Day 10]
Half time (t1/2) of gastric emptying (GE) of solids is the time for half of the ingested solids or liquids to leave the stomach.
- Change from baseline in American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) Composite Score at 15 days [Baseline and 15 days]
The ANMS GCSI-DD composite score includes score of nausea, early satiety, upper abdominal pain and postprandial fullness. The severity scores of these symptoms range from 0 ( none) to 4 (very severe).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosed with type 1 or type 2 diabetes
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Diagnosed with diabetic gastroparesis, defined by:
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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)
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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.
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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.
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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.
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Participants with uncontrolled diabetes. Participants with controlled diabetes are allowed (insulin is allowed). HbA1c>9.9% at screening are excluded.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Panax Clinical Research | Miami | Florida | United States | 33014 |
2 | International Research Associates, LLC | Miami | Florida | United States | 33183 |
3 | PRN of Kansas | Wichita | Kansas | United States | 67205 |
4 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
5 | ClinSearch | Chattanooga | Tennessee | United States | 37421 |
Sponsors and Collaborators
- Bird Rock Bio, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BRB-018-200DG