Diabetic GastroparesisPhase 2NCT03900325
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy of Nimacimab in Patients With Diabetic Gastroparesis
A Phase 2 study testing Nimacimab in people with Diabetic Gastroparesis, run by Bird Rock Bio, Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Gastroparesis
- What is being tested?
- Nimacimab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Aug 2019to Apr 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participants on prokinetic therapy should have these medications withdrawn at least 7 days prior to any study scintigraphy exam and at least 7 days prior to the first dose through Day 15 of treatment.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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
ClinSearch
Chattanooga, Tennessee, 37421
Panax Clinical Research
Miami, Florida, 33014
International Research Associates, LLC
Miami, Florida, 33183
Mayo Clinic
Rochester, Minnesota, 55905
PRN of Kansas
Wichita, Kansas, 67205
About this study
Official title: A Single-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy of Nimacimab in Patients With Diabetic Gastroparesis
This is a single blind phase 2a study to evaluate the safety, tolerability, pharmacokinetics, and exploratory efficacy of nimacimab in patients with diabetic gastroparesis.
- Conditions
- Diabetic Gastroparesis
- Being tested
- Nimacimab, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimacimabDrug
2.5 mg/kg
PlaceboDrug
0.9% sodium chloride
| Study group | Role | What they receive |
|---|---|---|
| Nimacimab | Experimental | 2.5 mg/kg Receives: Drug: Nimacimab |
| Placebo | Placebo comparator | 0.9% sodium chloride Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of clinically significant laboratory abnormalities
Measured: Day 38
Frequency of clinically significant vital signs
Measured: Day 38
Frequency of clinically significant ECGs
Measured: Day 38
Secondary outcomes (1)
Nimacimab serum concentration
Area under the plasma concentration versus time curve (AUC)
Measured: Day 3, Day 8, Day 10, Day 38
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start1 Aug 2019
- Primary completionJan 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic GastroparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bird Rock Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900325
- Sponsor's protocol ID
- BRB-018-200DG
- Status last verified
- Aug 2019
- First submitted
- 27 Mar 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy of Nimacimab in Patients With Diabetic Gastroparesis
- ClinicalTrials.gov ID
- NCT03900325
- Acronym / sponsor ID
- BRB-018-200DG
- Conditions
- Diabetic Gastroparesis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Bird Rock Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single blind phase 2a study to evaluate the safety, tolerability, pharmacokinetics, and exploratory efficacy of nimacimab in patients with diabetic gastroparesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nimacimab | Experimental | Drug: Nimacimab2.5 mg/kg |
| Placebo | Placebo comparator | Drug: Placebo0.9% sodium chloride |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with type 1 or type 2 diabetes
- Diagnosed with diabetic gastroparesis, defined by:
- BMI >= 20.0 and < = 50.0 kg/m2
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nimacimab2.5 mg/kg | Drug | Nimacimab |
| Placebo0.9% sodium chloride | Drug | Placebo |
Primary outcome
Frequency of clinically significant laboratory abnormalities
Time frame: Day 38
Frequency of clinically significant vital signs
Time frame: Day 38
Frequency of clinically significant ECGs
Time frame: Day 38
1 secondary outcome
Nimacimab serum concentration
Time frame: Day 3, Day 8, Day 10, Day 38
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nimacimab in people with Diabetic Gastroparesis, run by Bird Rock Bio, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of clinically significant laboratory abnormalities (time frame: Day 38). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.