Diabetic Gastroparesis
Conditions
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.
Interventions
DRUGNimacimab
2.5 mg/kg
DRUGPlacebo
0.9% sodium chloride
Sponsors
Bird Rock Bio, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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* Participants on prokinetic therapy should have these medications withdrawn at least 7 days prior to any study scintigraphy exam and at least 7 days prior to the first dose through Day 15 of treatment.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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of clinically significant laboratory abnormalities | Day 38 |
| Frequency of clinically significant ECGs | Day 38 |
| Frequency of clinically significant vital signs | Day 38 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nimacimab serum concentration | Day 3, Day 8, Day 10, Day 38 | Area under the plasma concentration versus time curve (AUC) |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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). |
| 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. |
Countries
United States
Outcome results
None listed